Evaluation of Pulsed Radiofrequency Ablation of the Superior Hypogastric Plexus for Treatment of Bladder Pain Syndrome: A Randomized, Placebo-Controlled Pilot Study
Phase: NA
Conditions: Bladder Pain Syndrome
Sponsor: Walter Reed National Military Medical Center

Evaluation of Pulsed Radiofrequency Ablation of the Superior Hypogastric Plexus for Treatment of 
Bladder Pain Syndrome: A Randomized, Placebo-Controlled Pilot Study 
Principal Investigator: Eli Medvescek, MD 
NCT Number: Not yet assigned 
Document date: 16 NOV 2023 

EIRB Protocol Template (Version 1.3)
1.0
General Information
*Please enter the full title of your study:
Evaluation of Pulsed Radiofrequency Ablation of the Superior Hypogastric Plexus for Treatment 
of Bladder Pain Syndrome: A Randomized, Placebo-Controlled Pilot Study
 
 
*Please enter the Protocol Number you would like to use to reference the protocol:
WRNMMC.1111
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this protocol.
 
 
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
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Does this protocol involve the use of animals?
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2.0
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2.1 List sites associated with this study:
Primary 
Dept?
Department Name
P and R - Walter Reed National Military Medical Center (WRNMMC)
 
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
 
Medvescek, Eli David
Select if applicable
Student
Site Chair
Resident
Fellow
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
Dengler, Katherine Laura, MD LTC 
 Associate Investigator
Griswold, Lauren Hoepfner, MD Capt 
N

 Associate Investigator
Wilson, Sara Merkl 
 Associate Investigator
B) Research Support Staff
Park, Edward Jongseok, MD CPT 
 Monitor
3.3 *Please add a Protocol Contact:
 
Dengler, Katherine Laura, MD LTC 
Griswold, Lauren Hoepfner, MD Capt 
Medvescek, Eli David 
Wilson, Sara Merkl 
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BERRY, KYLE Russel 
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4.1  
What department(s) will be associated with this protocol?
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Anesthesiology
Obstetrics And Gynecology
4.2  
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Is this protocol research, expanded access, or humanitarian use device?
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 What type of protocol is this?
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Behavioral Research
Biomedical Research
Clinical trial (FDA regulated)
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Humanitarian Use Device (HUD)
Psychosocial Research
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4.7  
Is this human subjects research? (As defined by 32 CFR 219) 
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   Human subject means a living 
individual about whom an investigator (whether professional or student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, and 
uses, studies, or analyzes the information or biospecimens; or 
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biospecimens.  
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 Do you believe this human subjects research is exempt from IRB review?
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5.0
 
Personnel Details
5.1  Does the Principal Investigator have a Permanent Change of Station (PCS) Date or Estimated 
Institutional Departure Date (EIDD)?
 Yes   
 No
Principal Investigator
Eli David Medvescek
06/30/2026
5.2  List any Research Team members without EIRB access that are not previously entered in the protocol:
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  Yes   
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5.4  
Will you have a Research Monitor for this study?
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N/A 
Research Monitor Qualifications
Ensure the individual has expertise consistent with the nature of risk(s) identified within your 
study and is independent of the team conducting the research.
Research Monitor Role:
1. Promptly reporting any observations and findings to the Institutional Review Board (IRB), the 
Human Protections Administrator (HPA), or the Institutional Official;
2. Stop the research study in the presence of safety concerns for the human subjects involved in 
the protocol. The RM may remove human subjects from the study and take any others actions 
necessary to protect the subjects of the study. The RM may discuss the protocol with the 
investigators, interview human subjects, and consult with others outside the protocol about the 
research;
3. Review the study monitoring plans, review Adverse Events and determine their relatedness to 
the protocol, review Unanticipated Problems Involving Risks to Subjects of Others, make 
recommendations on changes to the informed consent process based on the review of study 
events, and review and sign the continuing review report and other substantial submissions to 
the IRB.
4. Observe recruitment, enrollment, consent procedures and oversee study interventions.
If applicable, you may nominate an individual to serve as the Research Monitor:
Edward Jongseok Park, MD CPT
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
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Selected Users

7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
All personnel engaged in research must complete and attach a Conflict of Interest (COI) form.
8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
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8.2  Study Facilities and Locations:
Institution
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agreement?
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Attach international approval documents, if applicable, when prompted. Note: Ensure local 
research context has been considered
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Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to 
study approval)
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9.0
 
Study Details
9.1  Key Words:

Provide up to 5 key words that identify the broad topic(s) of your study
chronic pelvic pain, bladder pain syndrome, interstitial cystitis, superior hypogastric plexus, 
pulsed radiofrequency ablation
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the 
protocol.  The background section should clearly support the choice of study variables and 
explain the basis for the research questions and/or study hypotheses.  This section establishes 
the relevance of the study and explains the applicability of its findings
Interstitial cystitis / bladder pain syndrome (IC/BPS) is a complex chronic pain syndrome 
characterized by bladder pain, pressure, and discomfort with urinary urgency and frequency, 
without signs of infectious or alternative cause [1]. It disproportionately affects women, with an 
estimated 3-7% prevalence among women in the United States [2, 3], and with a prevalence of 
61% among women with chronic pelvic pain [4]. Pathophysiology is currently poorly understood 
and the cause is unknown [2, 5]. It is widely accepted that IC/BPS may be broken into Hunner-
type and non-Hunner type variants; however, beyond this histopathologic distinction, there 
remains a wide variety of proposed inflammatory, structural, autoimmune, infectious, functional, 
and neurogenic contributors to the overall picture of disease [2, 5]. 
Current treatment of IC/BPS in the United States is guided by recommendations from the 
American Urological Association (AUA) and the American Urogynecologic Society (AUGS). In 
2022, the AUA released updated guidance for treatment of IC/BPS. They outline a graded 
approach to uncomplicated IC/BPS, including non-pharmacologic and behavioral treatments 
(diet, education, stress management, physical therapy), oral medications, intravesical 
instillations, or procedures such as cystoscopy with hydrodistension, onabotulinumtoxinA 
injections, or neuromodulation [1]. Rather than presenting these therapies in a “step-up” 
fashion, the AUA notes that initial treatment type should depend on symptom severity and 
patient preference, and multiple simultaneous therapies may be considered. Surgery with 
cystectomy or bladder augmentation are considered last-resort therapies. Of note, many of these 
established treatment options may come with undesirable side effects, intolerable complications, 
risks associated with general anesthesia, or shorter-than-optimal duration of action. 
Some authors note that there is no one consistently effective treatment for IC/BPS [3, 6], and 
one estimate states that 10% of patients with IC/BPS are refractory to conservative, non-
surgical treatments [3]. There is also a substantial psychosocial burden of IC/BPS; most patients 
with the disease have seen numerous providers before being appropriately diagnosed, and have 
tried multiple therapies unsuccessfully [6]. These patients frequently experience concomitant 
voiding and bowel dysfunction, sexual dysfunction, mood disorders, social isolation, and greater 
unemployment [6]. 
One important contributor to the constellation of findings in IC/BPS is a shift towards 
sympathetically-mediated pain sensation in the setting of chronic pain [5]. Central sensitization 
is hypothesized to occur in IC/BPS as well as other chronic pelvic pain syndromes [2, 4, 5]. 
Williams et al found that subjects with IC/BPS had diminished vagal activity and a shift towards 
sympathetic nervous system dominance as reflected by decreased high-frequency heart rate 
variability on tilt table testing [7]. Charrua et al had similar findings, showing significantly lower 
mean variation of the standard deviation of the P wave interval (a marker of sympathetic 
overactivity) on tilt table testing as well as significantly higher twenty-four hour urinary 
noradrenaline in patients with IC/BPS [8]. These studies implicate autonomic nervous system 
aberrancy as a key factor in IC/BPS. Neuromodulation is the intervention of choice for managing 
hyperalgesic autonomic nervous system dysfunction [4]. While neuromodulation using 
implantable stimulators has been extensively studied in IC/BPS [3], little research has been done 
on chemical neurolysis, radiofrequency ablation, or other nerve interruption strategies for pain 
management in IC/BPS.  
Superior hypogastric plexus block (SHPB) is an interventional strategy used in chronic pain 
management initially investigated for the management of chronic cancer-related pelvic pain [9]. 
The procedure targets the superior hypogastric nerve plexus, which is a bilateral retroperitoneal 
structure at the approximate level of L5/S1. The structure provides innervation to pelvic viscera 
including the bladder, urethra, vagina, vulva, ovaries, uterus, and pelvic floor. A study conducted 
by Plancarte et al investigated the first use of SHPB for chronic pelvic pain related to cancer in 28 

patients. By injecting aqueous phenol in the retroperitoneal space overlying the superior 
hypogastric plexus, their team demonstrated a mean pain reduction of 70% in those treated with 
the block, with 3 patients experiencing durable pain relief for over two years [9].
Since it was first described, the method has been studied extensively in the management of 
chronic pelvic pain, having been demonstrated to be safe and effective in several prospective, 
retrospective, and randomized-controlled trials [10]. Rocha et al analyzed 180 patients across 10 
years treated with the block in a retrospective cohort study; their findings supported those of 
Plancarte et al, with 50% pain reduction observed in 48.8% of patients at 6 month follow-ups 
with no major complications or procedure-related morbidity [11]. Literature on the block is 
steadily growing, with numerous articles showing effective and safe use of the block in the 
conditions such as endometriosis [12, 13], adenomyosis [13], post-cesarean section pain [14], 
and even in a case of pain associated with Mayer-Rokitansky-Kuster-Hauser syndrome [15]. 
SHPB has also been explored for treatment of IC/BPS, though overall studies are lacking. A 
prospective unblinded randomized trial performed in Egypt [16] found that superior hypogastric 
plexus chemical neurolysis was inferior to bladder hydrodistention in some markers of IC/BPS 
relief; however, of note, this study was not placebo-controlled and lacked statistical power.
Since its inception, the SHPB has gone through several iterations. One exciting forefront is the 
use of pulsed radiofrequency ablation (pRFA) in targeting the nerves of the superior hypogastric 
plexus. pRFA was first introduced in the mid-1990s, and since then has been used extensively in 
the treatment of pain conditions such as cervical radicular pain, trigeminal neuralgia, groin and 
perineal  pain, myofascial pain, and complex regional pain syndrome [17, 18]. pRFA works by 
sending millisecond-duration bursts of current through an electrode tip inserted adjacent to a 
structure of interest [18]. Its exact mechanism is unknown [18], but is hypothesized to involve 
local thermal effects, high-intensity electric fields at the electrode tip, lower electric field 
phenomena that potentiate long-term depression of neuronal transmission, modifications to 
morphology of mitochondria in target tissues, and disruption of microfilaments and microtubules 
[17]. The evidence behind pRFA is promising, and its safety is extremely well established [17, 
18, 19] however, there is a striking paucity of prospective randomized controlled trials assessing 
its efficacy [18, 20]. Our literature review uncovered only one article investigating the use of 
pRFA of the superior hypogastric plexus for treatment of IC/BPS - a case report in which the 
patient experienced durable symptom relief for over two years. In their conclusion, the authors 
of this case report note that prospective randomized controlled study is warranted to confirm the 
clinical efficacy and safety of this procedure for the treatment of interstitial cystitis [21]. 
Given the factors outlined above - namely, (1) the predominance of central sensitization and 
sympathetic overactivation in IC/BPS, (2) the efficacy and anatomic relevance of SHPB in 
multiple pelvic pain syndromes, and (3) the established neuromodulatory utility of pRFA - it is 
reasonable to consider that pRFA of the superior hypogastric plexus may be an efficacious 
therapy for treatment of IC/BPS. Therefore, the primary aim of this study is to assess the 
efficacy of pRFA of the superior hypogastric plexus, as compared to treatment with sham, in 
patients with IC/BPS. The primary outcome will be post-intervention VAS pain scores at 1, 3, and 
6 month follow-ups. Secondary outcomes will include ratings of urinary manifestations, measures 
of mood symptoms, measures of sexual function, and overall patient satisfaction in both 
treatment and sham groups.
--
Citations:
[1] Clemens JQ, Erickson DR, Varela NP, Lai HH. Diagnosis and treatment of interstitial cystitis
/bladder pain syndrome. J Urol. 2022;208(1):34-42.
[2] Homma Y, Akiyama Y, Tomoe H, Furuta A, Ueda T, Maeda D, Lin AT, Kuo HC, Lee MH, Oh SJ, 
Kim JC, Lee KS. Clinical guidelines for interstitial cystitis/bladder pain syndrome. Int J Urol. 2020 
Jul;27(7):578-589. doi: 10.1111/iju.14234. Epub 2020 Apr 14. PMID: 32291805.
[3] Wang J, Chen Y, Chen J, Zhang G, Wu P. Sacral Neuromodulation for Refractory Bladder Pain 
Syndrome/Interstitial Cystitis: a Global Systematic Review and Meta-analysis. Sci Rep. 2017 Sep 
8;7(1):11031. doi: 10.1038/s41598-017-11062-x. PMID: 28887515; PMCID: PMC5591255.
[4] Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):
e98-e109. doi: 10.1097/AOG.0000000000003716. PMID: 32080051.
[5] Birder LA. Pathophysiology of interstitial cystitis. Int J Urol. 2019 Jun;26 Suppl 1:12-15. doi: 
10.1111/iju.13985. PMID: 31144735.

[6] Gupta P, Gaines N, Sirls LT, Peters KM. A multidisciplinary approach to the evaluation and 
management of interstitial cystitis/bladder pain syndrome: an ideal model of care. Transl Androl 
Urol. 2015 Dec;4(6):611-9. doi: 10.3978/j.issn.2223-4683.2015.10.10. PMID: 26816861; 
PMCID: PMC4708537.
[7] Williams DP, Chelimsky G, McCabe NP, Koenig J, Singh P, Janata J, Thayer JF, Buffington CA, 
Chelimsky T. Effects of Chronic Pelvic Pain on Heart Rate Variability in Women. J Urol. 2015 Nov;
194(5):1289-94. doi: 10.1016/j.juro.2015.04.101. Epub 2015 May 9. PMID: 25963185; PMCID: 
PMC8753597.
[8] Charrua A, Pinto R, Taylor A, Canelas A, Ribeiro-da-Silva A, Cruz CD, Birder LA, Cruz F. Can 
the adrenergic system be implicated in the pathophysiology of bladder pain syndrome/interstitial 
cystitis? A clinical and experimental study. Neurourol Urodyn. 2015 Jun;34(5):489-96. doi: 
10.1002/nau.22542. Epub 2013 Dec 24. PMID: 24375689; PMCID: PMC4069202.
[9] Plancarte R, Amescua C, Patt RB, Aldrete JA. Superior hypogastric plexus block for pelvic 
cancer pain. Anesthesiology. 1990 Aug;73(2):236-9. doi: 10.1097/00000542-199008000-00008. 
PMID: 2382849.
[10] Urits I, Schwartz R, Herman J, Berger AA, Lee D, Lee C, Zamarripa AM, Slovek A, Habib K, 
Manchikanti L, Kaye AD, Viswanath O. A Comprehensive Update of the Superior Hypogastric 
Block for the Management of Chronic Pelvic Pain. Curr Pain Headache Rep. 2021 Feb 25;25(3):
13. doi: 10.1007/s11916-020-00933-0. PMID: 33630172.
[11] Rocha A, Plancarte R, Nataren RGR, Carrera IHS, Pacheco VALR, Hernandez-Porras BC. 
Effectiveness of Superior Hypogastric Plexus Neurolysis for Pelvic Cancer Pain. Pain Physician. 
2020 Mar;23(2):203-208. PMID: 32214302.
[12] Wechsler RJ, Maurer PM, Halpern EJ, Frank ED. Superior hypogastric plexus block for 
chronic pelvic pain in the presence of endometriosis: CT techniques and results. Radiology. 1995 
Jul;196(1):103-6. doi: 10.1148/radiology.196.1.7784552. PMID: 7784552.
[13] Yang X, You J, Tao S, Zheng X, Xie K, Huang B. Computed Tomography-Guided Superior 
Hypogastric Plexus Block for Secondary Dysmenorrhea in Perimenopausal Women. Med Sci 
Monit. 2018 Jul 24;24:5132-5138. doi: 10.12659/MSM.906970. PMID: 30038207; PMCID: 
PMC6069504.
[14] Peker H, Atasayan K, Haliloglu Peker B, Kilicci C. Intraoperative superior hypogastric plexus 
block for pain relief after a cesarean section: a case-control study. Croat Med J. 2021 Oct 31;62
(5):472-479. doi: 10.3325/cmj.2021.62.472. PMID: 34730887; PMCID: PMC8596475.
[15] Srivastava M, Punj J. Management of cyclical pelvic pain by multiple ultrasound-guided 
superior hypogastric plexus blocks in a rare case of Mayer- Rokitansky-Küster-Hauser syndrome 
- A case series of three blocks in a patient. Intractable Rare Dis Res. 2019 Nov;8(4):271-274. 
doi: 10.5582/irdr.2019.01098. PMID: 31890455; PMCID: PMC6929597.
[16] El-Hefnawy AS, Makharita MY, Abed A, Amr YM, Salah El-Badry M, Shaaban AA. Anesthetic 
Bladder Hydrodistention Is Superior to Superior Hypogastric Plexus Neurolysis in Treatment of 
Interstitial Cystitis-bladder Pain Syndrome: A Prospective Randomized Trial. Urology. 2015 May;
85(5):1039-1044. doi: 10.1016/j.urology.2015.01.018. PMID: 25917730.
[17] Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain 
management: mechanisms and potential indications-a review. Acta Neurochir (Wien). 2011 Apr;
153(4):763-71. doi: 10.1007/s00701-010-0881-5. Epub 2010 Nov 30. PMID: 21116663; PMCID: 
PMC3059755.
[18] Zacharias NA, Karri J, Garcia C, Lachman LK, Abd-Elsayed A. Interventional Radiofrequency 
Treatment for the Sympathetic Nervous System: A Review Article. Pain Ther. 2021 Jun;10(1):
115-141. doi: 10.1007/s40122-020-00227-8. Epub 2021 Jan 12. PMID: 33433856; PMCID: 
PMC8119558.
[19] Choi EJ, Choi YM, Jang EJ, Kim JY, Kim TK, Kim KH. Neural Ablation and Regeneration in 
Pain Practice. Korean J Pain. 2016 Jan;29(1):3-11. doi: 10.3344/kjp.2016.29.1.3. Epub 2016 Jan 
4. PMID: 26839664; PMCID: PMC4731549.
[20] van Boxem K, van Eerd M, Brinkhuizen T, Patijn J, van Kleef M, van Zundert J. 
Radiofrequency and pulsed radiofrequency treatment of chronic pain syndromes: the available 
evidence. Pain Pract. 2008 Sep-Oct;8(5):385-93. doi: 10.1111/j.1533-2500.2008.00227.x. Epub 
2008 Aug 19. Erratum in: Pain Pract. 2010 Mar-Apr;10(2):164. Brinkhuize, Tjinta [corrected to 
Brinkhuizen, Tjinta]. PMID: 18721175.

1.  
1.  
2.  
3.  
4.  
2.  
3.  
4.  
[21] Kim JH, Kim E, Kim BI. Pulsed radiofrequency treatment of the superior hypogastric plexus 
in an interstitial cystitis patient with chronic pain and symptoms refractory to oral and 
intravesical medications and bladder hydrodistension: A case report. Medicine (Baltimore). 2016 
Dec;95(49):e5549. doi: 10.1097/MD.0000000000005549. PMID: 27930554; PMCID: 
PMC5266026.
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions
/hypotheses
Primary aim: Assess the efficacy of pRFA to the superior hypogastric plexus in the treatment of 
IC/BPS symptoms as compared to treatment with sham, as measured by pre- and post-
intervention visual analogue scale (VAS) pain scores at 1, 3, and 6 month follow-ups.
Secondary aims: Assess the efficacy of pRFA to the superior hypogastric plexus in the 
treatment of IC/BPS symptoms as compared to treatment with sham, as measured by:
Pre- and post-intervention urinary symptoms:
O'Leary/Sant (OLS) Voiding and Pain Indices
Number of daytime voids
Number of daytime leaks
Nocturia
Pre- and post-intervention mood symptoms as measured by the PHQ-9 at 1, 3, and 6-
month follow-ups. 
Pre- and post-intervention sexual function symptoms as measured by the Female Sexual 
Function Index (FSFI) at 1, 3, and 6-month follow-ups. 
Pre- and post-intervention patient satisfaction scores at 1, 3, and 6-month follow-ups as 
measured by the Patient Global Impression of Severity (PGI-S) and Patient Global 
Impression of Improvement (PGI-I) at 1, 3, and 6-month follow-ups. 
Null Hypotheses:
(1) No difference in VAS pain scores between treatment group and placebo group. 
Alternative Hypotheses:
(1) Pain scores will be significantly improved in the treatment group compared to placebo group 
at all interval follow-ups. 
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, 
cohort, etc.). Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug 
research
Single-blinded, placebo-controlled, single center prospective randomized clinical pilot trial.
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Women aged ≥ 18 with a diagnosis of IC/BPS who score ≥ 6 on the OLS symptom questionnaire.
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense

Research concerning effective treatment for IC/BPS has important implications for Active Duty 
servicemembers, their dependents, and retirees. A 2006 paper published in Military Medicine 
analyzed encounters of 1,737 deployed active duty females during Operation Iraqi Freedom, and 
found that 150 of these patients had a pelvic pain disorder, accounting for 14% of all patients 
seen for gynecologic services [22]. Many of these patients received a diagnosis of IC/BPS - this 
represents a barrier to valuable warfighting power and readiness in an operational environment. 
Investigating strategies to control symptoms associated with IC/BPS will help re-engage 
servicewomen in the fight earlier and with fewer symptoms. Retirees in the Veterans 
Administration (VA) also face a notable disease burden; one estimate lists the prevalence of IC
/BPS in VA patient population at 1.4% [23]. Importantly, as is given in the Background above, 
patients with chronic pain and mental health burdens are at an increased risk for complex and 
intractable symptoms related to IC/BPS [6]; there is known substantial overlap between these 
patients and the warfighter, who is at risk for mental health disorders such as PTSD and 
depression by virtue of Active Duty service [24]. When coupling the troubling disease burden 
above with the high cost of IC/BPS care (as is evidenced by multiple provider visits until 
diagnosis, and potentially multiple failed treatments before relief), pursuing novel treatment 
strategies at the intersection of urology, gynecology and chronic pain anesthesia may help 
decrease overall cost to the Department of Defense.
--
Additional citations:
[22] Wright J Jr, Albright TS, Gehrich AP, Dunlow SG, Lettieri CF, Buller JL. Pelvic pain presenting 
in a combat environment. Mil Med. 2006 Sep;171(9):841-3. doi: 10.7205/milmed.171.9.841. 
PMID: 17036603.
[23] Sohn MW, Zhang H, Taylor BC, Fischer MJ, Yano EM, Saigal C, Wilt TJ; Urologic Diseases in 
America Project. Prevalence and trends of selected urologic conditions for VA healthcare users. 
BMC Urol. 2006 Nov 3;6:30. doi: 10.1186/1471-2490-6-30. PMID: 17083728; PMCID: 
PMC1654168.
[24] Inoue C, Shawler E, Jordan CH, Jackson CA. Veteran and Military Mental Health Issues. 
2023 Mar 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan–. 
PMID: 34283458. 
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
All staff providers and fellows on the Walter Reed Urogynecology team and the Walter Reed 
Chronic Pain team will be briefed on the study goals, objectives, and inclusion criteria. Potential 
participants will be identified by healthcare providers on the above teams as part of regular 
clinical care. In order to adhere to WRNMMC’s recruitment policy, research activities will take 
place after clinic visit has ended.
WRNMMC healthcare providers will screen potentially eligible patients age 18 or older (inclusive) 
presenting to Urogynecology or Chronic Pain Clinic for IC/BPS treatment. These healthcare 
providers will briefly introduce the study and refer patients that express interest to the research 
team for formal consent. Designated providers in these clinics will provide an informational 
sheet, explain the study, express the voluntary nature of participation, assess interest in 
participating, and screen the potential participant for eligibility.
If the potential participant meets eligibility criteria as determined by the inclusion/exclusion 
criteria and expresses interest in participating in the study, an authorized study team member 
will initiate the formal consent discussion and obtain informed consent. If the potential 
participant is uncertain about their interest at the time of screening, they may contact the study 
team at a later date via email/phone provided on the study information sheet (which will be 
provided during the screening process) if they desire participation.
Consent will be obtained during the first study intake appointment in Chronic Pain by a member 
of the research team. During the consenting process, potential study subjects will be informed 

that the purpose of the study is to assess the efficacy of pulsed radiofrequency ablation of the 
superior hypogastric plexus for treatment of pain, urinary symptoms, sexual function, and mood 
symptoms associated with IC/BPS. They will be informed that the study is a randomized 
controlled trial and they will not be told whether they are receiving ablation or sham 
intervention. The procedure will be described to the patient. Potential complications and 
alternatives will be reviewed. The patient will be informed that they may withdraw their consent 
at any time, should they provide it, and that all participants will be offered the treatment at the 
conclusion of the study. If the subject provides consent, they will be randomized equally to a 
treatment group (pulsed radiofrequency ablation) or a sham group (50-50 split). 
The first appointment at Chronic Pain will review intake information and obtain baseline data, 
including: baseline VAS scores for IC/BPS, baseline OLS Voiding and Pain Indices, number of 
daytime voids, number of daytime leaks, frequency of nocturia, administration of the PHQ-9, 
administration of FSFI, current therapies (if any) for IC/BPS, and score rating current level of 
satisfaction with IC/BPS treatment as measured by PGI-S and PGI-I. These forms will be 
compiled in the patient’s study packet, which will include denotation of their treatment/placebo 
status and a coded identifier associated with the patient. This packet will be stored in a locked 
cabinet in the Chronic Pain Clinic. Data gathered at intake will also be transferred to a secure 
spreadsheet to which only study personnel have access, located on the internal Walter Reed 
network. After the intake interview, the patient will be consented for pulsed radiofrequency 
ablation utilizing a standardized pre-approved DD Form 522. The procedure will then be 
performed by a board-certified pain medicine physician who is a credentialed in performing the 
procedure. 
Prior to the procedure, cefazolin 2 mg IV will be administered for antibiotic prophylaxis. If the 
patient has an anaphylactic allergy to cefazolin, clindamycin 900 mg IV will be used for antibiotic 
prophylaxis. American Society of Anesthesiology (ASA) standard monitors will be applied 
(electrocardiogram, blood pressure cuff, pulse oximetry). Patients will be laid in the prone 
position with a pillow under their iliac crest. The L5-S1 interspace will be identified using 
fluoroscopy. The skin overlying this space will be prepared and draped in the usual sterile fashion 
utilizing chlorhexidine. Local anesthesia at the level of the skin and subcutaneous tissue, 
approximately 5-7cm bilateral to the midline at the level of the L4-L5 interspace, will be achieved 
using 1% lidocaine with bicarbonate. Thereafter, a hollow needle will be inserted at the site of 
local anesthesia directed towards the midline, angled approximately 30 degrees from the 
transverse plane and 45 degrees from the coronal plane. The needle will be advanced, also under 
fluoroscopic guidance, until the tip is observed at the anterolateral aspect of L5. The needle tip 
will then be advanced approximately 1 cm past the vertebral body, through the ipsilateral psoas 
muscle, into the retroperitoneal space. When both needles are inserted in identical fashion, 
soluble contrast will be injected to confirm correct placement in the retroperitoneum. 
For treatment arm: A microelectrode will be inserted through the hollow needle. A test 
pulse will be delivered so the provider can assess for tingling/discomfort in the 
appropriate anatomic distribution. When proper positioning has been confirmed, 4mL of 
1% lidocaine without epinephrine will be administered to reduce discomfort associated 
with radiofrequency ablation. Pulsed radiofrequency ablation will then be performed at a 
pulse frequency of 2Hz, pulse width of 20ms, temperature of 42 degrees Celsius, total 
duration 120 seconds. The microelectrode and hollow-tip needle will then be withdrawn. 
For sham arm: A microelectrode will be inserted through the hollow needle. A test pulse 
will be delivered so the provider can assess for tingling/discomfort in the appropriate 
anatomic distribution (although this is the sham group, this is consistent with previous 
sham operation of pulsed radiofrequency ablation; see [25, 26]). Sham pulsed 
radiofrequency ablation will then be performed with the radiofrequency generator 
disconnected from the microelectrode. The duration of the sham procedure will be 120 
seconds. The microelectrode and hollow-tip needle will then be withdrawn. 
The study participants will be monitored in the Chronic Pain clinic for 30 minutes post-procedure 
to assess for complications. The intake appointment will last approximately 1 - 1.5 hours. Prior 
to leaving the clinic, they will be scheduled for 1-month follow-up visit. 
At subsequent follow-ups, patients will complete surveys identical to those performed at intake - 
VAS score, OLS Voiding and Pain Indices, number of daytime voids, number of daytime leaks, 
frequency of nocturia, PHQ-9, number and type of treatments used in interim, and current level 
of satisfaction with IC/BPS treatment. Patients will not be restricted from using alternative IC
/BPS standard of care therapies (as outlined by the American Urological Association [AUA IC/BPS 

Treatment Algorithm 2022]) in the period between study treatments. These forms will be stored 
in the patient’s original packet. Follow-ups will occur at approximately 1-month, 3-month, and 6-
month intervals. Follow-up appointments will last approximately 30 minutes. 
If a participant fails to follow-up in the clinic, the participant will be contacted via telephone to 
reschedule as soon as possible. 
If complications related to the block occur, these patients will be referred to the Emergency 
Department for evaluation and managed on a case-by-case basis. 
--
Additional citations:
[25] Van Zundert J, Patijn J, Kessels A, Lamé I, van Suijlekom H, van Kleef M. Pulsed 
radiofrequency adjacent to the cervical dorsal root ganglion in chronic cervical radicular pain: a 
double blind sham controlled randomized clinical trial. Pain. 2007 Jan;127(1-2):173-82. doi: 
10.1016/j.pain.2006.09.002. Epub 2006 Oct 18. PMID: 17055165.
[26] Maatman RC, van Kuijk SMJ, Steegers MAH, Boelens OBA, Lim TC, Scheltinga MRM, 
Roumen RMH. A Randomized Controlled Trial to Evaluate the Effect of Pulsed Radiofrequency as 
a Treatment for Anterior Cutaneous Nerve Entrapment Syndrome in Comparison to Anterior 
Neurectomy. Pain Pract. 2019 Sep;19(7):751-761. doi: 10.1111/papr.12806. Epub 2019 Jul 19. 
PMID: 31188514.
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the 
data will be operationally measured.
The research team will collect the following information at intake (prior to pulsed radiofrequency 
ablation) and at follow-up appointments:
Demographic data (only measured at intake, not at follow-up): Age, race, ethnicity, 
height, weight, Active Duty military status)
VAS pain score at time of encounter: The visual analog scale (VAS) is a validated, 
subjective measure for pain. Scores are recorded by making a mark at any number of 
defined intervals on a 10-cm line that represents a continuum between “no pain” (0) and 
“worst pain” (10).  
O’ Leary-Sant Voiding and Pain Indices: Standardized, validated survey querying 
numerical ratings of urinary urgency, urinary frequency, nocturia, and bladder pain
/burning.
Average number of daytime voids over the prior week
Average number of daytime episodes of urinary incontinence over the prior week
PHQ-9: The PHQ-9 is a validated, 9-question tool to assess for the degree of depression 
present in an individual
Number of treatments tried in the past for BPS (only measured at intake, not at 
). 
follow-up
Number of treatments currently taking for BPS
Current level of satisfaction with BPS treatment: measured by PGI-S and PGI-I. 
The source of the data is the patient interview during intake and follow-up appointments. All data 
is measured as discrete quantitative variables, with patient satisfaction converted to a numerical 
rating (scale 1-5).
10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?

 Yes   
 No
10.4  Review the definitions below and respond to the following two questions.  If you are not sure of the 
answers, email 
 for assistance.
DHA.PrivacyBoard@mail.mil
   The 
 is 
Military Health System (MHS)
defined as all DoD health plans and DoD health care providers that are organized under the 
management authority of, or in the case of covered individual providers, assigned to or employed by, 
  
the Defense Health Agency (DHA), the Army, the Navy, or the Air Force  
 
MHS workforce members
are employees, volunteers, trainees, and other persons whose conduct, in the performance of work 
  
for the MHS, is under the direct control of the MHS, whether or not they are paid by the MHS.  MHS 
 are persons or entities that provide a service to the MHS and require protected 
business associates
health information (PHI) to provide the service.
Are you an MHS workforce member?
Yes, I am an MHS workforce member 
No, I am not an MHS workforce member 
10.5  Have you consulted with an MHS data expert to determine the data elements required for your study?
Consulting with a data expert often saves time later in the compliance process because the data 
expert can advise on the data available in the numerous MHS information systems, the quality of 
that data and the methods for encrypting and collapsing data.  To schedule a consult with an 
MHS data expert, send an email to: (
)
DHA.PrivacyBoard@mail.mil
Yes, then complete the questions below according to the data consult 
No, then complete the questions below according to the best of your knowledge 
10.6  Indicate how you will request data from the MHS.  Select all that apply.
Talking with MHS health care providers or MHS health plans about specific research 
participants
Obtaining MHS hard copy records specific to research participants
Obtaining data from an MHS information system(s)
10.7  If you are obtaining data from an MHS information system(s), indicate whether you plan to receive a 
data extract or whether you plan to access an MHS information system directly to create a data set.
A data extract is when the MHS or a contractor provides the data set directly to the 
researcher.  When receiving a data set through data extract, the researcher may indicate 
whether the data elements should be provided as is, encrypted or collapsed.  In contrast to a 
data extract, access to an information system means that the researcher may directly access an 
MHS information system and create a data set for the research study
Data Extract
Access
10.8  Do you intend to request de-identified data from the MHS in your research study? 
There are different two methods for de-identifying data pursuant to HIPAA:
1) Safe Harbor Method: Removing all of the identifiers listed in Table 1 below, provided that the 
researcher does not have actual knowledge that the remaining data can be used alone or in 
combination with other information to identify the individual who is the subject of the information
2) Statistical Method: An expert, with appropriate knowledge of and experience with generally 
accepted statistical and scientific principles and methods for rendering information not 
individually identifiable, determines that the data is not individually identifiable
  Yes   
  No

10.9  Indicate the MHS information system(s) from which you will seek to obtain data
If you do not know which system(s) contains the data elements you need, refer to the Guide for 
DoD Researchers on Using MHS Data or request guidance from an MHS data expert at: DHA.
.
PrivacyBoard@mail.mil
 
Below is a list of commonly used MHS systems. If the system from which you seek to obtain 
data is not listed below, list the name of the system in the “Other MHS Systems” category below
PHI Systems:
MHS Information System
Requesting Data
:
MHS Genesis
:
Yes
PII-Only Systems:
MHS Information System
Requesting Data
No records have been added
De-Identified Data & Other Systems:
Information System
Requesting Data
No records have been added
10.10  Do you intend to merge or otherwise associate the requested data with data from any sources 
outside of the MHS, including other DoD systems that are not part of the MHS?
Yes, will merge data  
No, will not merge data 
10.11  Indicate the data elements about research participants or relatives, employers, or household 
members of the research participants that you will request from MHS hard copies or from MHS 
information systems. 
If you will merge data, also indicate non-MHS data elements about research participants or 
relatives, employers, or household members of the research participants that you will have access 
to in any form or medium.
Direct and 
Indirect 
Identifiable Data 
Elements
DHA Hard 
Copies
DHA Data 
Elements 
to be 
Accessed
DHA Data 
Elements 
Verbal
Extracted 
DHA Digital 
Data
Downloaded 
DHA Digital 
Data
Non-DHA 
Hard 
Copies or 
Digital
1.  Names 
2.  Postal 
address with 
only town, 
city, state, 
and zip code 
3.  Postal 
address with 
all geographic 
subdivisions 
smaller than 
state, 
including 
street 

address, city, 
county, 
precinct, zip 
code and their 
equivalent 
geocodes, 
except for the 
initial three 
digits of a zip 
code if, 
according to 
the current 
publicly 
available data 
from the 
Bureau of 
Census: 1) 
the 
geographic 
unit formed by 
combining all 
zip codes with 
the same 
three initial 
digits contains 
more than 
20,000 
people; and 2) 
the initial 
three digits of 
a zip code 
from all such 
geographic 
units 
containing 
20,000 or 
fewer people 
is changed to 
000
4.  Dates 
including all 
elements 
(except year) 
directly 
related to an 
individual, 
including 
birthdate, 
admission 
date, 
discharge 
date, and date 
of death 
5.  Ages over 
89 and all 
elements of 
dates 
(including 
year) 
indicative of 
such age, 
unless you will 
only request a 
single 
category of 

“age 90 or 
older” 
6. Telephone 
Numbers
7.  Fax 
Numbers 
8.  Email 
Addresses
9.    Social 
Security 
Numbers
10.   Medical 
Record 
Numbers 
(MRN) 
(including 
record ID)
11.   Health 
Plan 
Beneficiary 
Numbers  
(including 
DEERS ID, 
Electronic 
Data 
Interchange 
Personal 
Identifier 
(EDIPI) or 
Number 
(EDIPN))
12.   Account 
Numbers 
13.   Certificate
/License 
Numbers 
14.   Vehicle 
identifiers and 
serial 
numbers, 
including 
license plate 
numbers 
15.   Device 
identifiers and 
serial numbers 

16.   Web 
Universal 
Resource 
Locators 
(URLs) 
17.   Internet 
Protocol (IP) 
address 
numbers 
18.   Biometric 
identifiers, 
including 
finger and 
voice prints 
19.   Full-face 
photographic 
images and 
any 
comparable 
images
20.   Any 
other unique 
identifying 
number, 
characteristic, 
or code 
(including non-
military 
provider IDs)
21.   Free Text 
Fields
If you are obtaining SSNs, provide a justification as to why and explain why a substitute cannot 
be used.
Due to guidelines stated within DoDI 1000.30, Reduction of SSN Use within DoD, the reduction 
or elimination of SSN usage must occur wherever possible. If SSNs are required to complete the 
project, the PI must provide a justification and explanation as to why a substitution cannot be 
used.
For example:
• If alternatives to SSN (e.g., EDIPNs or pseudo person IDs) are sufficient in other instances, 
will those alternatives to SSN usage be sufficient to respond to Congressional inquiries and
/or Senior DoD stakeholders inquiries?
• Are alternatives to SSN used first?
• Are those alternatives to SSN insufficient to combine data from multiple data sources? Is 
the issue that some individuals do not possess alternatives ID numbers and SSN is the only 
way to identify them?
N/A - Not accessing SSNs. 
a. Will you receive or obtain health information?

Note: If you indicate you are not receiving health information, the answer 
must be consistent with the DHA data source. For a non-health 
information data request, if you are a non-MHS employee or non-MHS 
business associate, you may not access an information system that has 
PHI or LDS. For both MHS and Non-MHS employees and MHS business 
associates, you may 
 include data elements in the above table on: 
NOT
1)  lines 10 or 11, 2) line 21 if the free text field comes from a PHI or LDS 
system, and 3) lines 12, 13, or 18 if the account numbers, certificate and 
license numbers, biometric data, or any other data elements are health 
information created or received by an MHS health care provider, health 
plan, or business associate in relation to the physical or mental health or 
condition of an individual or payment for health care.
Yes, I will receive or obtain health information 
No, I will not receive or obtain health information 
b. If no data elements were checked in the above table, is it possible that the requested DHA 
data is or will be identifiable because of any unique data elements, triangulation, or small cell 
size?  
Data elements were checked in the above table, STOP HERE.
NOTE: A unique data element includes any unique features that alone are not identifiable but 
that could be used to identify an individual within the context of other information, such as any 
type of code (such as diagnosis or procedural), rank of general or admiral, gender, or race. 
Triangulation means using different data elements that when combined can be used to identify 
an individual, such as including the above lists of unique data elements in a data set. 
Determining whether an individual is identifiable through triangulation requires consideration of 
all data elements in combination. Within the military, the use of rank and/or diagnosis code, 
procedural codes, or any other code that changes on a predictable basis, increases the possibility 
of identification. Small cell size means that there is only a small number of eligible individuals 
that satisfy the category description. Department of Defense Manual 6025.13, Medical Quality 
Assurance and Clinical Quality Management in the Military Health System MHS, provides that the 
threshold for de-identifying data within the MHS requires a cell size of three, but also states that 
the de-identification standards must meet the DoD implementation of the HIPAA Privacy Rule. 
Centers for Medicare and Medicaid also gives guidance on small cell size stating that no data cell 
less than 11 may be published or displayed. However, the Office for Civil Rights’ OCR, which is 
the official regulatory office for the HIPAA Privacy Rule, provides that OCR does not designate a 
universal value for small cell size in accordance with the de-identification standard; instead, the 
cell size should be set at a level that is appropriate to mitigate risk of identification by the 
anticipated recipient of the data set. This means that a cell size of 3 or 11 may not meet the 
HIPAA Privacy Rule requirements if the cell size level does not appropriately mitigate risk of 
identification by the anticipated recipient of the data set.
Note: If dates are altered as a means of de-identifying the data, diagnosis and 
procedural codes need to be rolled-up or collapsed. If dates are provided “as time 
between events,” the roll-up is not necessary.   
Yes, the DHA data will become identifiable
No, the DHA data will not become identifiable
10.12  Do you believe it is possible for the MHS data to become identifiable because of triangulation, a 
small cell size, or any unique data element(s)?
Triangulation means using different data elements that are not themselves identifiable but that 
when combined can be used to identify an individual. For example, triangulation would use rank 
and race together to determine the identity of an individual with a particular health condition.
 
Small cell size means that there is only a small number of eligible individuals that satisfy the 
category description. Guidance for acceptable cell size is available from the Centers for Medicare 
and Medicaid Services. For example, the rank category of four star generals with a particular 
diagnosis may be less than 30, so the rank category may need to be expanded to include lower 
ranks.
 

A unique data element includes any unique features that are not explicitly enumerated in the 
categories of data in rows 1 – 20 of the table above (in Section 10.10), but that could be used to 
identify an individual. Unique data elements include characteristics that are not themselves 
identifying, such as the rank of general or admiral, or a race or gender, but within the context of 
other information could be identifiable.
Yes, I believe there is a reasonable possibility the MHS data will become identifiable 
No, I believe there is no reasonable possibility the MHS data will become identifiable 
10.13  Have you completed and uploaded an appropriate HIPAA document ( i.e. HIPAA Authorization will 
be obtained or Waiver/alteration of HIPAA Authorization is being requested)?
Yes 
No 
N/A 
If yes, please check which one.
HIPAA Authorization
HIPAA Waiver (Full or Partial)
Other (please provide copies when uploading Other Study Documents)
10.14  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
this Study:
Include in this section the plan for acquiring data (both electronic and hard copy), access during 
the study, data/specimen storage and length of time stored, shipment/transmission, and the 
plan for storage and final disposition at the conclusion of the study. Describe any data 
agreements in place for accessing data within and/or outside of your institution (e.g., Data 
Sharing Agreement, Data Use Agreement, Business Agreements, etc.)
Initial data will be collected at the Chronic Pain intake and study consenting appointment. 
Information to include PHI (name, telephone number) will be annotated on a physical Intake 
Data Collection Sheet (see protocol attachment). Data collection sheets will be coded to 
associate each subject with a number. Subjects will be asked about past medical and surgical 
history as well as allergies and current medications. Data variables as outlined in section 10.2 
above will also be gathered and stored on the physical Intake Data Collection Sheet. 
All data sheets will be collected at the completion of each day and placed in a locked cabinet in a 
locked office in the Chronic Pain clinic. These data sheets will be transcribed within one week to a 
master data collection sheet (data repository), which will include coded subject identifiers as well 
as data variables as outlined above. This master data collection sheet will be an Excel document 
kept exclusively on Walter Reed servers, requiring CAC as well as invitation-only folder access. 
These documents (hard copy and electric) can only be accessed by the Research Team (PI, AIs, 
study coordinators). The Primary Investigator will be available for debriefing of any subject after 
the study is completed if the subject desires. The PI will also be available for any questions 
during the course of the study. Data in the Excel spreadsheet will be analyzed with the 
assistance of a biostatistician. At the conclusion of the study, any associations between coded 
data and identity of participants will be destroyed, thereby de-identifying any data retained for 
future research (see 10.15 below). 
The Principal Investigator agrees to maintain a Study File that must be kept for three years from 
the date the study is closed (32 CFR 219.115(b)) and that HIPAA authorizations will be retained 
for 6 years after the study is closed and provided to WRNMMC upon request. PI acknowledges 
that research data are the property of the Command and will not be removed without prior 
approval. When PI is scheduled for permanent change of station (PCS) or end of time in service 
(ETS), study records will be given to a new PI.
Is this a data repository?
 Yes   
 No
If Yes, provide name of the Repository.

PRFA_SHPB_REPO
Who will have access to the Repository?
Principal investigator and associate investigators.
What data type will be stored in the Repository?
Protected Health Information
Limited Data Set
De-identified Data
10.15  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
Future Research:
If the study involves collecting, storing, or banking human specimens, data, or documents 
(either by the Investigator or through an established repository) for FUTURE research, address. 
How the specimens/data will be used, where and how data/specimens will be stored (including 
shipping procedures, storage plan, etc.), whether and how consent will be obtained, procedures 
that will fulfill subjects’ request as stated in the consent, whether subjects may withdraw their 
data/specimens from storage, whether and how subjects may be recontacted for future research 
and given the option to decline, whether there will be genetic testing on the specimens, who will 
have access to the data/specimens, and the linkage, the length of time that data/specimens will 
be stored and conditions under which data/specimens will be destroyed.
This study will involve the retention of de-identified data for potential future research. Consent 
for retention of data will be obtained at the initial intake appointment via the Informed Consent 
process. Subjects have the option to decline retaining their de-identified data for future research. 
Subjects have the option to withdraw their data from the study at any time during or after their 
study participation. However, subjects will not be re-contacted or re-consented for use of their 
data after the initial Informed Consent process. 
De-identified data will be stored electronically in a CAC-protected, invitation-only folder local to 
Walter Reed servers. The original hard-copy data, containing subject PHI, will be maintained for 
three years as given in 10.14 above, then destroyed. Any associations, master list, or other 
markers that allow connection between data and subjects will be destroyed at the conclusion of 
the study. When the PI is scheduled for permanent change of station (PCS) or end of time in 
service (ETS), de-identified electronic study records for use in future research will be given to the 
Department Head if the study as outlined in this IRB proposal has concluded. 
Is this a data repository?
 Yes   
 No
If Yes, provide the name of the Repository
PRFA_SHPB_REPO
Who will have access to the Repository?
Principal investigator and associate investigators.
What data type will be stored in the Repository?
Protected Health Information
Limited Data Set
De-identified Data
11.0
 
Statistical/Data Analysis Plan
11.1  Statistical Considerations:

List the statistical methods to be used to address the primary and secondary objectives, specific 
aims, and/or research hypotheses.  Explain how missing data and outliers will be handled in the 
analysis.  The analysis plan should be consistent with the study objectives.  Include any sub-
group analyses (e.g., gender or age group).  Specify statistical methods and variables for each 
analysis.  Describe how confounding variables will be controlled in the data analysis
See sections 11.2-11.6.
11.2  Sample Size:
N=38.
11.3  Total number of subjects requested (including records and specimens):
38
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm
(1) Pulsed radiofrequency ablation of superior hypogastric plexus: 15 evaluable patients (19 due 
to anticipated dropout ~20%)
(2) Sham intervention of superior hypogastric plexus: 15 evaluable patients (19 due to 
anticipated dropout ~20%)
11.5  Please provide a justification for your sample size
This is a pilot study. Thus, sample size will be informed by the size of previous studies within 
similar disciplines. 
Numerous previous prospective studies investigating superior hypogastric plexus block with 
chemical neurolysis show the following sample sizes:
Plancarte 1990, prospective patient series, n=28 [9]
Yang 2018; prospective patient series, n=25 [13]
El-Hefnawy 2015, RCT, n=24 [16]
Gamal 2006, RCT, n=30 [27]
Bhatnagar 2012, prospective patient series, n=18 [28]
Mishra 2013, RCT, n=50 [29]
Ghoneim 2014, RCT, n=30 [30]
Erdine 2003, prospective patient series, n=20 [31]
Likewise, previous randomized controlled trials investigating radiofrequency ablation in the 
treatment of other chronic pain syndromes show the following sample sizes:
Manjunath 2008, complex regional pain syndrome, n=20 [32]
Bang 2019, abdominal pain, n=26 [33] 
Shaaban 2018, various chronic pain syndromes, n=40 [34]
Based on the above, we argue that n=30 is an appropriate, scientifically-supported sample size. 
When factoring in for anticipated dropout (~20%), this yields a total sample size of 38. 
Using GPower 3.1, power can be calculated for a range of effect sizes with alpha = 0.05, one-
tailed t-test, and total sample size n = 30:

Effect size        Power
0.1 ------------- 8.4%
0.3 ------------- 20.0%
0.5 ------------- 37.9%
0.7 ------------- 59.0%
0.9 ------------- 77.6%
Given that this is a pilot study, as well as the numbers above, we do not expect to achieve power 
= 80%.
--
Additional citations:
[27] Gamal G, Helaly M, Labib YM. Superior hypogastric block: transdiscal versus classic 
posterior approach in pelvic cancer pain. Clin J Pain. 2006 Jul-Aug;22(6):544-7. doi: 10.1097/01.
ajp.0000202978.06045.24. PMID: 16788341.
[28] Bhatnagar S, Khanna S, Roshni S, Goyal GN, Mishra S, Rana SP, Thulkar S. Early 
ultrasound-guided neurolysis for pain management in gastrointestinal and pelvic malignancies: 
an observational study in a tertiary care center of urban India. Pain Pract. 2012 Jan;12(1):23-
32. doi: 10.1111/j.1533-2500.2011.00467.x. Epub 2011 May 26. PMID: 21615855.
[29] Mishra S, Bhatnagar S, Rana SP, Khurana D, Thulkar S. Efficacy of the anterior ultrasound-
guided superior hypogastric plexus neurolysis in pelvic cancer pain in advanced gynecological 
cancer patients. Pain Med. 2013 Jun;14(6):837-42. doi: 10.1111/pme.12106. Epub 2013 Apr 11. 
PMID: 23577819.
[30] Ghoneim AA, Mansour SM. Comparative study between computed tomography guided 
superior hypogastric plexus block and the classic posterior approach: A prospective randomized 
study. Saudi J Anaesth. 2014 Jul;8(3):378-83. doi: 10.4103/1658-354X.136625. PMID: 
25191191; PMCID: PMC4141389.
[31] Erdine S, Yucel A, Celik M, Talu GK. Transdiscal approach for hypogastric plexus block. Reg 
Anesth Pain Med. 2003 Jul-Aug;28(4):304-8. doi: 10.1016/s1098-7339(03)00191-3. PMID: 
12945023.
[32] Manjunath PS, Jayalakshmi TS, Dureja GP, Prevost AT. Management of lower limb complex 
regional pain syndrome type 1: an evaluation of percutaneous radiofrequency thermal lumbar 
sympathectomy versus phenol lumbar sympathetic neurolysis--a pilot study. Anesth Analg. 2008 
Feb;106(2):647-9, table of contents. doi: 10.1213/01.ane.0000298285.39480.28. PMID: 
18227328.
[33] Bang JY, Sutton B, Hawes RH, Varadarajulu S. EUS-guided celiac ganglion radiofrequency 
ablation versus celiac plexus neurolysis for palliation of pain in pancreatic cancer: a randomized 
controlled trial (with videos). Gastrointest Endosc. 2019 Jan;89(1):58-66.e3. doi: 10.1016/j.gie.
2018.08.005. Epub 2018 Aug 16. PMID: 30120957.
[34] Shaaban MH, Reyad RM, Ghobrial HZ, Hashem RH. Ultrasound guided versus fluroscopic 
guided pulsed radiofrequency therapy of the stellate ganglion in neuropathic pain: a prospective 
controlled comparative study. Egypt J Radiol Nucl Med. 2018;49(1):71–75. doi: 10.1016/j.ejrnm.
2017.06.008
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:
As per the CONSORT guidelines for randomized controlled trials, a patient flow diagram 
will be presented to describe recruitment, exclusions, randomization, dropouts, loss to 
follow-up and subjects included in the analysis.
Baseline demographic data, as well as number of treatments tried in the past for IC/BPS, 
for both intervention (pulsed radiofrequency ablation of the superior hypogastric plexus) 
and sham groups will be collected at intake and presented using means and standard 
deviations. These groups will be compared to assess for statistically significant findings 
between treatment and sham group. 

The primary outcome of interest is the subject’s bladder pain score on a VAS numerical 
rating scale from 0-10, completed prior to the procedure as well as at 1-, 3-, and 6-
month follow-ups in both the intervention and sham groups. Subjects will be scheduled as 
closely as possible to these follow-up timelines, although small variations (+/- 10 days) 
will be tolerated due to clinic availability, subject availability, holiday closures, and other 
unanticipated barriers to follow-up. The primary outcome will be reported as a mean and 
standard deviation for both intervention and sham groups. Assuming normality, means 
between treatment and sham groups will be compared with repeated measures analysis 
of variance. 
Secondary outcomes of interest will also be completed prior to the procedure as well as at 
1-, 3-, and 6-month follow-ups and include the following. These outcomes will be 
reported using mean and standard deviation and compared between the intervention 
group and the sham group using repeated measures analysis of variance. 
O’ Leary-Sant Voiding and Pain Indices
Average number of daytime voids over the prior week
Average number of daytime episodes of urinary incontinence over the prior week
PHQ-9 scores
FSFI scores
Number of treatments currently taking for BPS
Current level of satisfaction with BPS treatment as measured by PGI-S and PGI-I 
scores. 
The pattern of any adverse events will be described. Although the rates of these 
outcomes are likely to be low in this small sample size, if sufficient numbers of adverse 
events occur, we will compare the rate of adverse events using either binomial or Poisson 
regression models.
12.0
 
Participant Information
12.1  Subject Population:
DEERS-eligible women aged ≥ 18 with a diagnosis of IC/BPS who score ≥ 6 on the OLS symptom 
questionnaire, seen in Walter Reed Urogynecology or Chronic Pain clinics for treatment of IC
/BPS. 
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does 
not match the range(s) selected, please specify in the text box.
0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
12.3  Gender:
Male

Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel
Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
You must also consider the requirements of DoDI 3216.02, paragraph 7.e. 
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraphs 7.e. and 12.
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.
Depending on your intended subjects’ status, you may also need to consider the requirements of 
DoDI 3216.02, Enclosure 3, paragraph 7.e.
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Female sex
 
2 
Age ≥ 18
 
3 
Diagnosis of bladder pain syndrome
 
4 
Score of ≥ 6 on O'Leary-Sant Voiding and Pain Indices
 
5 
DEERS-eligible health care beneficiaries. 
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Patients with current enabled implantable neurostimulation (i.e. TENS, Interstim)
 
3 
Current active pelvic or gynecologic malignancy
 

4 
Coagulation disorder
 
5 
Local infection at injection site
 
6 
Sepsis
 
7 
Decompensated cardiac or hemodynamic disorders
 
8 
Neurogenic bladder and patients with spinal cord injury
 
8 
Current pregnancy
 
9 
Structural abnormalities of the spine that prevent performance of the procedure
 
10 
Intravesical onabotulinumtoxin A injection within the last 3 months. 
 
13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
The Urogynecology clinic schedule will be reviewed for appointments for IC/BPS on a daily basis 
by WRNMMC Urogynecology staff physicians and fellows. Likewise, the Chronic Pain Service will 
be reviewed for appointments for IC/BPS on a daily basis by WRNMMC Chronic Pain staff 
physicians and fellows. Screening will occur at this time. All female subjects 18 years of age or 
older with a diagnosis of IC/BPS from Urology or Urogynecology, currently eligible to receive care 
at WRNMMC, with OLS score ≥ 6, and without evidence of exclusion criteria, will be considered 
candidates for recruitment in this study. These subjects will be recruited at the time of their 
appointment by a staff physician or fellow not associated with the study, who will provide study 
verbal information and an informational handout. In order to adhere to WRNMMC’s recruitment 
policy, research activities will take place after clinic visit has ended. No patients will be pressured 
or coerced into participating in the study. 
If a potential subject is screened for study participation, they will be added by clinic staff to a 
protected Shared Drive patient list accessible only by study personnel. If they express interest in 
study participation, this will be denoted on the patient list and a Referral Request 2.0 will be 
placed by the referring Urogynecology provider (or a follow-up appointment booked by the 
referring Chronic Pain provider) for the Chronic Pain clinic for intake appointment. Specific 
mention of study participation will be made in the Referral Request 2.0. Consent for study 
participation will occur at the first Chronic Pain intake appointment by an authorized member of 
the research team. 
13.2  Compensation for Participation:
There is no monetary compensation for joining the study. 
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor
See section 13.1.
13.4  Consent Process:   Revised Common Rule, Section 219.116:  General requirements for informed 
consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in 
accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad 
consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and 

(c) of this section only with respect to the storage, maintenance, and secondary research uses of 
identifiable private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes   
  No
Please explain the consent process:
Informed Consent Process
Formal consent will occur at the subject's first Chronic Pain intake appointment; prior to this, the 
subject will have received information about the study via in-person discussion and handout as 
outlined above in section 13.1. An overview of the study will be recapitulated when administering 
consent. Study participants will then review the study consent form in detail with a member of 
the Chronic Pain Anesthesia team present. Adequate time will be allowed for answering questions 
or concerns. After signing, the subject will be given a copy of the signed consent, and a copy will 
remain on file in a locked cabinet in the Chronic Pain Clinic. If the subject elects to not 
participate or not provide consent, they will nevertheless be offered the opportunity to complete 
their appointment with a Chronic Pain clinician, should they desire discussion about other pain 
management options within the standard of care. Subjects may choose to leave the study at any 
point without consequence.
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the 
opportunity to withdraw their data their data/specimens in the event they wish to withdraw from 
the study
Subjects can decide to withdraw from study participation at any time by informing the PI or 
research staff via phone, in-person, in-writing, or electronic mail. Withdrawal will not affect 
future care at WRNMMC. Those that withdraw will be offered the opportunity to withdraw their 
data from the study as well. 
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach 
of confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do 
not describe risks from standard care procedures; only describe risks from procedures done for 
research purposes
Breakage of the skin for the purposes of intervention poses principal risks of bleeding, infection, 
and damage to surrounding structures. Given the anatomic location of intervention, vascular 
structures with potential for accidental injury include the distal abdominal aorta as well as left
/right common iliac arteries, left/right common iliac veins, and inferior vena cava. The ureters 
are similarly exposed to potential injury in this procedure. Inadvertent puncture of an 

intervertebral disc when passing the needle lateral to the vertebral body holds the theoretical 
risk of discitis. Although the superior hypogastric plexus is located retroperitoneally, accidental 
passage into the peritoneum could lead to bowel or bladder injury. These risks will be minimized 
by (1) using fluoroscopic and tactile guidance in multiple planes of view to ensure appropriate 
anatomic positioning of the needle; (2) pre-procedure administration of cefazolin 2g for antibiotic 
prophylaxis against infection; (3) use of sterile technique; and (4) use of expert operators 
training in anesthesia and chronic pain. 
There is a very low risk of transient hypotension associated with the procedure. Patients will be 
connected to standard ASA monitors including blood pressure, pulse oximetry, and 
electrocardiogram in order to quickly detect hemodynamic abnormalities. Vasoactive medications 
as well as blood products will be available in the event of severe intractable hypotension and/or 
intra-abdominal bleeding. Patients will be monitored in the post-procedure period for 30 minutes 
for detection of hemodynamic abnormalities. 
Patients are exposed to risk secondary to small doses of radiation applied for imaging guidance. 
This risk will be minimized by using the smallest dose of radiation necessary for facilitation of 
needle placement. Fluoroscopy will only be used over the anatomic area of interest, with 
protection of adjacent areas with lead aprons. 
Given the abundance of structures located in the target area of therapy, participants are at risk 
for nonspecific discomfort, such as backache, transient hematuria, or numbness and tingling of 
the lower extremities, both during and after the procedure. The full range of these nonspecific 
discomforts cannot be predicted. Conservative, supportive care will be available as needed to 
help minimize discomfort. 
There is a risk that the intervention does not lead to resolution of pain, voiding, and/or mood 
symptoms for patients with IC/BPS. 
Breach of confidentiality is always a risk when working with confidential information. However all 
data collected will be accessible only to research team members and stored in a locked, secure 
location either in the Chronic Pain clinic or on a Walter Reed network drive. 
A comprehensive update of the superior hypogastric plexus block for the management of chronic 
pelvic pain by Urits et al (2021) analyzes chemical neurolysis of the superior hypogastric plexus 
in numerous prospective, retrospective, and randomized controlled studies as well as case 
reports and case series; 300+ patients were collectively analyzed with no complications greater 
than Clavien Dindo Grade I reported. This demonstrates a large body of evidence suggesting 
safety of the procedure across multiple prior studies.
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate 
risk of harms to subjects and study personnel
Measures to minimize/eliminate risk provided in-line in section 14.1. 
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and 
records throughout the study and at its conclusion (e.g., destruction, long term storage, or 
banking). Explain the plan for securing the data (e.g., use of passwords, encryption, secure 
servers, firewalls, and other appropriate methods). If data will be shared electronically with 
other team members/collaborators outside the institution, describe the method of transmission 
and safeguards to maintain confidentiality. Explain whether this study may collect information 
that State or Federal law requires to be reported to other officials or ethically requires action, e.
g., child or spouse abuse

Once a patient is enrolled in the study, the treating provider on the Chronic Pain team will assign 
a subject identifier (01, 02, 03, etc) and record this identifier on the subject's physical intake 
forms. Immediately after the subject's intake appointment, the physical intake forms (including 
data and consents) will be placed in a folder and stored in a single locked cabinet in an office in 
the Chronic Pain clinic. Data from physical intake forms will be transferred to electronic data in a 
coded manner using the subject identifiers given above (i.e. only storage of coded data) on a 
government-issued computer Excel document that is password and CAC protected and only 
exists on local WRNMMC servers.
Subjects will be asked in their initial consent for permission to maintain their de-identified data 
after the completion of the study for use in future research. Data will be modified from coded to 
de-identified at the conclusion of the study by the removal of all numbering, connections, and/or 
master lists that allow association between subject code and data. All subjects will have their 
physical data shredded and disposed of in a HIPAA-compliant bin at the conclusion of the study, 
with the exception of those documents required to be retained by the Principal Investigator by 32 
CFR 219.115(b). In addition, those patients that decline maintenance of their data will have their 
electronic data deleted at the conclusion of the study. The informed consent document with 
HIPAA Authorization will be held for a minimum of 6 years and then shredded and disposed in a 
HIPAA compliant receptacle per WRNMMC protocol. The Principal Investigator or a designee on 
the research team will be responsible for destroying this information.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits 
to a specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and 
they cannot provide their own consent, the protocol must describe the intent to directly benefit 
all subjects
Subjects may benefit by having a decrease in the bladder or pelvic pain, decrease in pain 
medication use, decrease risk of medication side effects, decreased adverse urinary symptoms, 
improved mood, and improved quality of life.
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and 
all research activities, etc.
The subject’s privacy will be protected by performing all study procedures in a private room; this 
includes obtaining consent and medical history, performing exams, and administration of the 
intervention. The only personnel that will be present will be the study investigators, research 
coordinator, and staff, such as nurses, who will assist with procedures under the direction of the 
study investigator. The subject and her family member(s) or spouse will be made to feel at ease 
by limiting the number of personnel present, and encouraging the subjects to ask questions and 
notify the staff if she is uncomfortable in any way.
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject 
could possibly benefit medically or otherwise from the information, state whether or not the 
results of screening, research participation, research tests, etc., will be shared with subjects or 
their primary care provider. State whether the researcher is obligated or mandated to report 

results to appropriate military or civilian authorities and explain the potential impact on the 
subject
Participants will be informed of any incidental findings. Depending on the type of incidental 
finding, the participant may be contacted by phone. In the case of a potential serious 
emergency, the PI or designee will be responsible for informing the participant right away. 
Participants will not have an option to decline receiving information about an incidental finding. A 
qualified person (usually a member of the research team) will talk with the participant if there is 
an incidental finding. The participant will be referred to an appropriate doctor for further 
evaluation.
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
A DSMP should describe the plan to monitor the data to verify that the data are collected and 
analyzed as specified in the protocol. Include who will conduct the monitoring, what will be 
monitored, and the frequency of monitoring. It should also include the plan to ensure the safety 
of subjects
The PI will be responsible for ensuring all data that are collected and analyzed are being 
performed as specified per protocol. Prior to the start of the study, the PI will meet with all 
clinicians performing the recruitment (Urogynecology, Chronic Pain) and pulsed radiofrequency 
ablation (Chronic Pain) to present the study protocol. Any points of clarification or concern will be 
addressed at that time by the PI, and at any point during the study period if questions or issues 
arise. Data sheets will be reviewed by the principal or associate investigators on a bi-weekly 
basis to ensure completion and accuracy. The data being monitored includes all questionnaires 
(demographic data sheet, OLS questionnaire, VAS pain scores, PHQ-9 questionnaires, overall 
satisfaction scores, and all other data collected at intake and follow-up appointments contained 
within participant packets) as well as adverse outcomes. Safety of subjects will be ensured by 
employing standard technique for approach and access to the superior hypogastric plexus, and 
using pulsed radiofrequency ablation equipment in an approved manner, all by expert operators 
with fellowship training in Chronic Pain. All subjects will be monitored for any immediate or 
delayed adverse effects of the study interventions.
Subjects will be administered the PHQ-9 survey as part of data collection. This survey screens for 
depressive symptoms including suicidal ideation. If the PHQ-9 reveals concern for depression, 
the results will be discussed with the patient directly and a referral for mental health will be 
placed if the patient does not already have an established mental health provider. If indicators of 
suicidal ideation are identified, this will also be directly discussed with the patient. Dr. 
Worthington, the mental health provider embedded within the Gynecology clinic, would be 
contacted to see the patient immediately if available. If she is not available, the patient would be 
walked down to the emergency department and a warm hand-off given to the emergency 
provider. 
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent form 
are needed and the scale that will be used to grade the severity of the adverse event. 

Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse 
events will be for this study, describe the likelihood (frequency, severity, reversibility, short-
term management and any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or 
consent form are needed and the scale that will be used to grade the severity of the adverse 
event
Reportable Events include adverse events (AE), serious adverse events (SAE), unanticipated 
problems involving risks to subjects or others (UPIRTSO), and protocol deviations as defined by 
the WRNMMC IRB Handbook.
Expected reportable events and events that are not related to study participation are reported on 
the Continuing Review (CR) Progress Report. CR is generally performed on a 12-month cycle. 
More frequent Progress Reports may be required at the discretion of the IRB.
Serious Adverse Events: The PI, within 24 hours, must report all related or possibly-related AND 
serious adverse events (SAE) occurring in subjects enrolled at WRNMMC. This is accomplished by 
submitting an adverse event report to the IRB via eIRB. For protocols involving investigational 
drugs or devices, the investigator must also report a serious adverse event to the sponsor of the 
IND or IDE immediately (within 24 hours). Serious adverse events must be reported even if the 
PI believes that the adverse events are unrelated to the protocol.
UPIRTSOs, unexpected AEs, and SAEs (in the opinion of the PI) that are possibly related to 
participation AND places subjects or others at a greater risk of harm that was previously known 
or recognized in the protocol and must be reported to the IRB and Research Monitor via email or 
telephone within 24 hours of discovery and a written follow up report within 5 business days.
When a protocol deviation occurs, the investigator shall report the occurrence to the IRB. The 
investigator is required to make the determination whether the deviation meets the criteria for 
an unanticipated problem involving risks to subjects or others. The IRB Chair or IRB staff 
member shall also make the determination if the protocol deviation meets the definition of an 
unanticipated problem involving risks to participants or others. If the IRB Chair or IRB Staff 
member determines and documents that the deviation is an unanticipated problem involving 
risks to subjects or others or the deviation resulted from serious or continuing noncompliance, 
the IRB staff member shall place the deviation on the agenda of the next available IRB meeting 
for review. If the IRB Chair or IRB Staff member determines and documents that the deviation is 
not an unanticipated problem involving risks to subjects or others, the IRB Chair or staff member 
shall acknowledge the submission and complete the review through an administrative review 
procedure. Deviations that are determined to be minor as defined by the WRNMMC IRB 
Handbook are reported on the Continuing Review (CR) Progress Report as stated above.
As a reminder, according to DoDI 3216.02 (November 8, 2011), the IRB shall approve an 
independent research monitor by name for all DoD-conducted research involving human 
subjects, determined by the IRB to involve more than minimal risk to human subjects. 
Additionally, the research monitor may be identified by an investigator or appointed by an IRB or 
Institutional Official (IO) for research involving human subjects determined to involve minimal 
risk.
The research monitor may perform oversight functions and will report their observations to the 
IRB or a designated official. The research monitor may discuss the research protocol with the 
investigators, interview human subjects, and consult with others outside of the study about the 
research. The research monitor shall have the authority to stop a research protocol in progress, 
remove individual subjects from a research protocol, and take whatever steps are necessary to 
protect the safety and well-being of human subjects until the IRB can assess the monitor’s 
report. Research monitors shall have the responsibility to promptly report their observations and 
findings to the IRB or other designated official.
The research monitors shall have expertise consonant with the nature of risk(s) identified within 
the research protocol, and they shall be independent of the team conducting the research 
involving human subjects.
17.0
 
Equipment/non-FDA Regulated Devices

17.1  Does the study involve the use of any unique non-medical devices/equipment?
  Yes   
  No
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.3  Device Details:
Are device(s) in this research being used in accordance to the approved labeling?
Are device(s) in this research being used in a manner other than its approved labeling?
When adding a device indicate in the details section of the device if the use is either used in 
accordance to the approved labeling or in a manner other than it's approved labeling
View Details
Device Name
Radiopaque Radiofrequency Cannula 
Manufacturer/Supplier of 
Device
Avanos 
Where will the Devices Be 
Stored
Chronic Pain Clinic 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
 
Radiofrequency Probe, Long 
Manufacturer/Supplier of 
Device
Kimberly-Clark 
Where will the Devices Be 
Stored
Chronic Pain Clinic 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
 
Multi-Radiofrequency Module 

Manufacturer/Supplier of 
Device
Kimberly-Clark 
Where will the Devices Be 
Stored
Chronic Pain Clinic 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
 
Pain Management Generator, Advanced, v4 
Manufacturer/Supplier of 
Device
Kimberly-Clark 
Where will the Devices Be 
Stored
Chronic Pain Clinic 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
 
18.4  Reporting Requirements for FDA-regulated research under IND and IDE:
Describe the process for complying with FDA regulatory requirements for adverse event 
reporting and adverse device effects reporting to the sponsor
N/A
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 

20.0
 
References and Glossary
20.1  References:
[1] Clemens JQ, Erickson DR, Varela NP, Lai HH. Diagnosis and treatment of interstitial cystitis
/bladder pain syndrome. J Urol. 2022;208(1):34-42.
[2] Homma Y, Akiyama Y, Tomoe H, Furuta A, Ueda T, Maeda D, Lin AT, Kuo HC, Lee MH, Oh SJ, 
Kim JC, Lee KS. Clinical guidelines for interstitial cystitis/bladder pain syndrome. Int J Urol. 2020 
Jul;27(7):578-589. doi: 10.1111/iju.14234. Epub 2020 Apr 14. PMID: 32291805.
[3] Wang J, Chen Y, Chen J, Zhang G, Wu P. Sacral Neuromodulation for Refractory Bladder Pain 
Syndrome/Interstitial Cystitis: a Global Systematic Review and Meta-analysis. Sci Rep. 2017 Sep 
8;7(1):11031. doi: 10.1038/s41598-017-11062-x. PMID: 28887515; PMCID: PMC5591255.
[4] Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):
e98-e109. doi: 10.1097/AOG.0000000000003716. PMID: 32080051.
[5] Birder LA. Pathophysiology of interstitial cystitis. Int J Urol. 2019 Jun;26 Suppl 1:12-15. doi: 
10.1111/iju.13985. PMID: 31144735.
[6] Gupta P, Gaines N, Sirls LT, Peters KM. A multidisciplinary approach to the evaluation and 
management of interstitial cystitis/bladder pain syndrome: an ideal model of care. Transl Androl 
Urol. 2015 Dec;4(6):611-9. doi: 10.3978/j.issn.2223-4683.2015.10.10. PMID: 26816861; 
PMCID: PMC4708537.
[7] Williams DP, Chelimsky G, McCabe NP, Koenig J, Singh P, Janata J, Thayer JF, Buffington CA, 
Chelimsky T. Effects of Chronic Pelvic Pain on Heart Rate Variability in Women. J Urol. 2015 Nov;
194(5):1289-94. doi: 10.1016/j.juro.2015.04.101. Epub 2015 May 9. PMID: 25963185; PMCID: 
PMC8753597.
[8] Charrua A, Pinto R, Taylor A, Canelas A, Ribeiro-da-Silva A, Cruz CD, Birder LA, Cruz F. Can 
the adrenergic system be implicated in the pathophysiology of bladder pain syndrome/interstitial 
cystitis? A clinical and experimental study. Neurourol Urodyn. 2015 Jun;34(5):489-96. doi: 
10.1002/nau.22542. Epub 2013 Dec 24. PMID: 24375689; PMCID: PMC4069202.
[9] Plancarte R, Amescua C, Patt RB, Aldrete JA. Superior hypogastric plexus block for pelvic 
cancer pain. Anesthesiology. 1990 Aug;73(2):236-9. doi: 10.1097/00000542-199008000-00008. 
PMID: 2382849.
[10] Urits I, Schwartz R, Herman J, Berger AA, Lee D, Lee C, Zamarripa AM, Slovek A, Habib K, 
Manchikanti L, Kaye AD, Viswanath O. A Comprehensive Update of the Superior Hypogastric 
Block for the Management of Chronic Pelvic Pain. Curr Pain Headache Rep. 2021 Feb 25;25(3):
13. doi: 10.1007/s11916-020-00933-0. PMID: 33630172.
[11] Rocha A, Plancarte R, Nataren RGR, Carrera IHS, Pacheco VALR, Hernandez-Porras BC. 
Effectiveness of Superior Hypogastric Plexus Neurolysis for Pelvic Cancer Pain. Pain Physician. 
2020 Mar;23(2):203-208. PMID: 32214302.
[12] Wechsler RJ, Maurer PM, Halpern EJ, Frank ED. Superior hypogastric plexus block for 
chronic pelvic pain in the presence of endometriosis: CT techniques and results. Radiology. 1995 
Jul;196(1):103-6. doi: 10.1148/radiology.196.1.7784552. PMID: 7784552.
[13] Yang X, You J, Tao S, Zheng X, Xie K, Huang B. Computed Tomography-Guided Superior 
Hypogastric Plexus Block for Secondary Dysmenorrhea in Perimenopausal Women. Med Sci 
Monit. 2018 Jul 24;24:5132-5138. doi: 10.12659/MSM.906970. PMID: 30038207; PMCID: 
PMC6069504.
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20.2  Abbreviations and Acronyms:
AUGS: American Urogynecologic Society
AUA: American Urological Association
ASA: American Society of Anesthesiologists
FSFI: Female Sexual Function Index
IC / BPS: Interstitial cystitis / bladder pain syndrome
OLS: O' Leary-Sant Voiding and Pain Indices
PGI-S: Patient Global Impression of Severity
PGI-I: Patient Global Impression of Improvement
PHQ: Patient Health Questionnaire 
pRFA: Pulsed radiofrequency ablation
PTSD: Post-traumatic stress disorder
SHPB: Superior hypogastric plexus block
TENS: Transcutaneous electrical nerve stimulation
VAS: Visual analog scale
VA: Veterans Administration
WRNMMC: Walter Reed National Military Medical Center