A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
Phase: PHASE3
Conditions: Interstitial Cystitis, Levator Spasm, Bladder Pain Syndrome
Sponsor: Jocelyn Fitzgerald

Project Title: A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic 
Pain 
NCT Number: NCT05658874 
Document Date Approved: 6/13/2024 
 
Summary:  
 
Chronic Pelvic Pain is a debilitating, multimodal disease with several contributing organ 
systems. As a result, adequate treatment of this disease requires multimodal pain 
therapy from a team of experts. Other multimodal pain bundles (such as ERAS in the 
perioperative setting) have been shown to be superior to any bundle component being 
used as a monotherapy. This study will assess patient response to a bundled-care 
approach to CPP both pre-and post intervention as well as compared to a site 
randomized “usual care” cohort.  
 
Background/Rationale:  
 
Chronic pelvic pain (CPP) is a common, debilitating condition experienced by up to 26% 
of adult women12, costing billions in direct healthcare costs and indirect productivity 
costs annually3. CPP deeply affects women’s quality of life, including everyday 
functioning and intimacy. Though there is no consensus definition, it is generally defined 
as generally defined as non-cyclic pain perceived to be in the pelvic area that has 
persisted for three to six months or longer and is unrelated to pregnancy4. 
 
CPP is challenging to treat, as it typically is insidious and the pathophysiology 
involves overlap of several related neuroimmune disorders affecting a litany of pelvic 
end-organs, including the muscles of the pelvic floor/vagina, bladder, colon and rectum, 
as well as the bony pelvis and hip girdle5. It is closely tied to conditions such as 
endometriosis, interstitial cystitis, and irritable bowel syndrome. It is also exacerbated by 
emotional, physical, and sexual trauma, and worsened by central sensitization by 
depression, anxiety, and substance abuse6. Systemic pain conditions such as 
fibromyalgia and autoimmune diseases are commonly found in women with CPP7. On 
average, women who experience CPP may have a 4-11 year delay in diagnosis8 and 
seek the consultation of multiple providers before they find a pelvic pain specialist with 
an understanding of the complex mechanisms that perpetuate pain.  
 
 
Most women who present to CPP specialists have tried several monotherapies, 
including combined oral contraceptive pills, repeated doses of antibiotics, over the 
counter pain medications, and other psychoactive medications, many of which are part 
of chronic pain treatment algorithms.  In women with interstitial cystitis, the 2015 and 
2022 AUA IC/PBS guidelines91011 for treatment remain algorithmic and stepwise, despite 
literature that suggests that sequential monotherapy is a poor strategy 12. Only recently 
have studies emerged showing that multidisciplinary clinics for female CPP are both 
clinically effective and cost effective 13 14 and may improve uptake/compliance with 
physical therapy15 and mental health recommendations, which are poor in this cohort16 
17While many studies have been done over decades of research on the various 
mechanistic cascades that perpetuate chronic pain, there has been little to no research 
done on a “bundled” approach to chronic pain. Care bundles are a set of three to five 
evidence-informed practices performed collectively and reliably to improve the quality of 
care1819. 
 

This approach takes advantage of treating pain as a polymodal affliction20, 
requiring treatment for central-neural sensitization pathways2122, emotional trauma, 
infectious/microbiome modulation232425, immune factors, surgical interventions2627, and 
physical therapy for end-organ rehabilitation28. Similar studies on “bundled care” have 
been done for infection control and show that no single intervention reduces infection in 
a significant way, but collectively each component of the care bundle provides dramatic 
improvements29. From an acute and postoperative pain standpoint, Enhanced Recovery 
After Surgery (ERAS) bundles have shown remarkable effectiveness for improving 
postoperative recovery30 despite studies that fail to show effectiveness for components 
of the bundle as monotherapies3132. However a similar bundled, multimodal approach 
has not been formally presented or studied for CPP.  
 
 
Objectives: 
 
The goals of this research program are to evaluate the patient-reported outcomes of a 
multimodal care bundle for patients presenting to a multidisciplinary CPP clinic 
compared to “usual care” in an FPMRS or Urology clinic.   
 
Primary Aim:  
 
To compare pre and post intervention self-evaluation of pain and function scores in 
women with chronic pain syndromes with a primary finding of urinary/bladder pain 
symptoms and/OR levator spasm who undergo multi-disciplinary, bundled care 
compared with usual care in a FPMRS or Urology clinic setting.   
 
 
Secondary Aims:  
 
a) To identify and phenotype “non-responders” to a bundled approach to 
IC/PBS/CPP.  
 
 
Hypothesis: We hypothesize that a bundled, multidisciplinary care approach will 
significantly improve patient scores on validated outcomes questionnaires compared to 
usual care.  
 
Methods:  
 
All treatment plans, medications, and procedures recommended for patients involved in 
this study are within the current standards of care for IC/PBS/CPP, regardless of 
treatment arm and are known to be safe interventions.  
 
Study Design: Single center, randomized pre-post intervention/prospective cohort 
study33 of usual FPMRS care vs. multimodal, multidisciplinary care bundle (MMCB).  
 
STROBE34 guidelines were utilized.  
 
Setting: Patients will be recruited from an outpatient Female Pelvic Medicine and 
Reconstructive Surgery (FPMRS) clinic. They will subsequently be randomized to a 

Multidisciplinary CPP clinic at an alternate site vs. continuing usual outpatient care in 
FPMRS as above.  
 
Study Population/Participants: Eligible participants include self-referred women 18 
years and older with a clinical diagnosis of IC/PBS (based on history and symptoms) 
who scored 6 points or greater on the problem OR symptom index of the O’Leary Sant 
Questionnaire.  Every attempt will be made to fulfill a representation quotient35.  
 
Inclusion Criteria: Female patient 18 years of age or older, clinical diagnosis of CPP 
and IC/PBS, scoring 6 points or higher on O’Leary Sant Questionnaire (IC/PBS arm) OR 
levator spasm diagnosed by an FPMRS specialist.  
 
Exclusion Criteria: active pelvic or bladder infection within past 2 weeks, 
contraindications to medications or intervention therapeutics, inability to speak or read 
English; pelvic floor interventional procedure including bladder instillations 4 weeks prior 
to study recruitment, meets criteria for diagnostic laparoscopy (dysmenorrhea, uterine 
pain, cyclic pelvic pain, dyspareunia, GI symptoms)  
 
Note: patients are not excluded for currently taking any medication on the treatment list.  
Patients can be treated for UTI during the study period.  
 
Randomization: If patients meet inclusion criteria and agree to participate, they will be 
randomized by RedCap3637 either to remain in “usual” care in the FPMRS or Urology 
clinic or transition their care to the multidisciplinary CPP clinic at the UPMC Lemieux 
Center.  
 
 
Definition of outcome measure and method of ascertainment: 
 
Data collected at baseline, 6 weeks, 12 weeks, 6 months, 1 year  
 
Demographic Data 
 
Age 
Self-Identified Race 
Height/Weight/BMI 
Menopausal Status 
Currently using hormones  
 
 
-Oral contraceptives (list) 
 
-Intrauterine device (list) 
 
-Hormone replacement  
 
-Hormone-containing topical cream or ointment 
 
-Other (list)  
Other pain conditions 
 
Fibromyalgia 
 
Migraine 
 
Endometriosis 
Prior treatments for chronic pelvic or bladder pain (list) 
Number of vaginal deliveries 
Number of cesarean deliveries 
Prior treatments for pelvic bladder pain 

 
Medications 
 
Pelvic floor physical therapy 
 
Cystoscopy with hydrodistention 
 
Other cystoscopy 
 
Pelvic floor injections 
History of culture-proven recurrent UTIs (yes/no)  
 
-Give details 
History of psychiatric diagnoses 
 
Depression 
 
Anxiety 
 
Bipolar disorder 
 
PTSD 
 
Psychosis/Hallucinations 
Other (list) 
History of physical or sexual abuse (yes/no) 
 
 
Primary Outcome  
--O’Leary Sant Questionnaire (OLS)38, comprised of Interstitial Cystitis Symptom Index 
(ICSI) and Problem Index (ICPI), at 12 weeks from baseline 
 
MCID: 4 points for ICSI 
 
Secondary Outcomes 
 
-NRS Scale 
-McGill Pain Questionnaire, Short Form 39 
-Pain Disability Index 40 
-Pelvic Pain and Urgency/Frequency Questionnaire (PUF)41 
-Pelvic Floor Distress Inventory (PFDI)-2042 
 
MCID: 45 points (15%) 
-Female Sexual Function Index (FSFI)43 
 
MCID: 2.1 points 
-Pain Catastrophizing Scale (PCS)44 
-Patient Global Impression of Improvement (PGI-I)45 
 
 
1) Healthcare utilization defined as number of additional encounters for chronic 
pelvic and bladder pain diagnosis outside of the defined study period  
a. Phone calls 
b. Office visits 
c. ER visits 
d. Procedures 
 
 
Intervention:  
 
Components of MMCB (all) 
 
1) MD Evaluation (FPMRS or Urology) 
2) Pelvic floor physical therapy (PFPT) 

3) Behavioral health consult if patient does not have established behavioral/psychiatric 
care 46→with appropriate psychiatric referrals/treatments 
 
4) Central sensitization/neurogenic pain:  
 
Amitriptyline 10-50mg 21 
Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 
 
5) Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 
0.25% Marcaine, total 23-33cc) in office or under anesthesia  
 
 
6) Urinary symptoms IC/PBS ONLY 
 
Spasm: OAB medication chosen based on patient characteristics/insurance, dose may 
be increased as tolerated (anticholinergic vs. b-agonist) 
7) Pyridium 100-300mg/day 
 
8) Microbiome: Methenamine47 
9) Vaginal estrogen23  
 
At least once within 12 weeks of initial visit:  
 
10) Intravesical evaluation: Cystoscopy to evaluate for hunner ulcers or variant (treat 
with Kenalog injection alone if Hunner ulcers or variant with or without hydrodistention if 
no hunner ulcers)  
 
11) Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, available 
glucocorticoid (dexamethasone, etc), gentamicin48)  
 
 
-Invasive interventions to be repeated as needed per patient.  
 
Data will be stored and managed in a RedCap database37  
 
Measures to reduce loss to follow up:  
Phone calls and email  from study coordinators.  
 
Potential confounding variables: patients frequently have overlapping pain 
syndromes; likely many different CPP phenotypes. Patients will be enrolled sequentially.  
 
Demographic data:  
 
Age, self-identified race, BMI, menopausal status, past medical history, past surgical 
history, psychiatric history, tobacco, sexual assault/abuse history, history of prior 
interventions for their chronic pain condition, internal vs. external referral 
 
Study Size/Power Calculation: based on the primary outcome, the primary outcomes 
is defined as the change in the total OLS score from baseline to 12 weeks compared 
between the groups. Based on previous studies, patients with IC/BPS have a baseline 
OLS score following standard medical treatment of 24 ± 5.6 190 points. 3849. A 4.03-point 

decrease from baseline on the OLS-ICSI corresponds with at least a 50% perceived 
improvement in symptoms25, we have chosen to use 6 points, to represent 75% 
improvement. We desired 90% power to detect a 6-point or larger difference in the mean 
score change between the groups with a 2-sided t-test at a significance level of 
alpha=0.05. Accounting for 20% dropout, the target sample size was 40 for each group 
(80 total).  
 
Ethical Concerns: 
 
Pain patients are a vulnerable population.  
 
Strengths/Weaknesses; patients cannot be blindly randomized, interventions are 
evidence-based but not being studied separately. There are likely differing phenotypes 
of pain patients (endometriosis vs. infectious vs. trauma) making for a heterogenous 
population.  
 
Timeline: 12 month enrollment and 12 month follow up.  
 
Budget:  
 
Research Manager (1-2 years)-$10K  
Research Operations Coordinator (1-2 years) $25K 
Data Collection Tools (RedCap, database management, tablets for surveys, statistics, 
analytics)-$5K 
Patient Incentives: 5 time points  
$25 for each first 4 visits, $50 for final visit ($12K)  
Promotional Materials/Design/Publicity -$1K 
General Materials (Office supplies including file folders, printing supplies)$1K 
Mail supplies (postage)$1K 
 
Estimated Total: $50K 
 
 
 
 
 
 
References:  
 
1. 
Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. 
Pain Physician. 2014;17(2):E141-147. 
2. 
Chronic Pelvic Pain: ACOG Practice Bulletin Summary, Number 218. Obstet 
Gynecol. 2020;135(3):744-746. doi:10.1097/AOG.0000000000003717 
3. 
Armour M, Lawson K, Wood A, Smith CA, Abbott J. The cost of illness and 
economic burden of endometriosis and chronic pelvic pain in Australia: A national 
online survey. PloS One. 2019;14(10):e0223316. 
doi:10.1371/journal.pone.0223316 

4. 
Fall M, Baranowski AP, Elneil S, et al. EAU Guidelines on Chronic Pelvic Pain. Eur 
Urol. 2010;57(1):35-48. doi:10.1016/j.eururo.2009.08.020 
5. 
Professionals SO. EAU Guidelines: Chronic Pelvic Pain. Uroweb. Accessed May 5, 
2021. https://uroweb.org/guideline/chronic-pelvic-pain/#note_33 
6. 
Lampe A, Sölder E, Ennemoser A, Schubert C, Rumpold G, Söllner W. Chronic 
Pelvic Pain and Previous Sexual Abuse. Obstet Gynecol. 2000;96(6):929-933. 
7. 
Sinaii N, Cleary SD, Ballweg ML, Nieman LK, Stratton P. High rates of autoimmune 
and endocrine disorders, fibromyalgia, chronic fatigue syndrome and atopic 
diseases among women with endometriosis: a survey analysis. Hum Reprod. 
2002;17(10):2715-2724. doi:10.1093/humrep/17.10.2715 
8. 
Agarwal SK, Chapron C, Giudice LC, et al. Clinical diagnosis of endometriosis: a 
call to action. Am J Obstet Gynecol. 2019;220(4):354.e1-354.e12. 
doi:10.1016/j.ajog.2018.12.039 
9. 
Intertitial Cystitis (IC/BPS) Guideline - American Urological Association. Accessed 
January 20, 2021. https://www.auanet.org/guidelines/interstitial-cystitis-(ic/bps)-
guideline 
10. Hanno Philip M., Erickson Deborah, Moldwin Robert, Faraday Martha M. Diagnosis 
and Treatment of Interstitial Cystitis/Bladder Pain Syndrome: AUA Guideline 
Amendment. J Urol. 2015;193(5):1545-1553. doi:10.1016/j.juro.2015.01.086 
11. Clemens JQ, Erickson DR, Varela NP, Lai HH. Diagnosis and Treatment of 
Interstitial Cystitis/Bladder Pain Syndrome. J Urol. 2022;208(1):34-42. 
doi:10.1097/JU.0000000000002756 
12. Nickel JC, Downey J, Ardern D, Clark J, Nickel K. FAILURE OF A 
MONOTHERAPY STRATEGY FOR DIFFICULT CHRONIC 
PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME. J Urol. 2004;172(2):551-
554. doi:10.1097/01.ju.0000131592.98562.16 
13. Westbay LC, Adams W, Kistner M, et al. Clinical Outcomes of a Multidisciplinary 
Female Chronic Pelvic Pain Program. Female Pelvic Med Reconstr Surg. 
2021;Publish Ahead of Print. doi:10.1097/SPV.0000000000001045 
14. Jochum SB, Legator H, Abraham RR, et al. It Takes a Village: The First 100 
Patients Seen in a Multidisciplinary Pelvic Floor Clinic. Female Pelvic Med 
Reconstr Surg. 2021;27(4):e505. doi:10.1097/SPV.0000000000000884 
15. Brown HW, Barnes HC, Lim A, Giles DL, McAchran SE. Better together: 
multidisciplinary approach improves adherence to pelvic floor physical therapy. Int 
Urogynecology J. 2020;31(5):887-893. doi:10.1007/s00192-019-04090-w 
16. Fullerton ME, Mwesigwa PJ, Tandel MD, Kwan L, Grisales T, Tarnay CM. 
Comparison of Pelvic Floor Physical Therapy Attendance Based on Referring 
Provider Specialty. Female Pelvic Med Reconstr Surg. 2021;Publish Ahead of 
Print. doi:10.1097/SPV.0000000000001061 

17. Woodburn KL, Tran MC, Casas-Puig V, Ninivaggio CS, Ferrando CA. Compliance 
With Pelvic Floor Physical Therapy in Patients Diagnosed With High-Tone Pelvic 
Floor Disorders. Female Pelvic Med Reconstr Surg. 2021;27(2):94-97. 
doi:10.1097/SPV.0000000000000732 
18. Lavallée JF, Gray TA, Dumville J, Russell W, Cullum N. The effects of care bundles 
on patient outcomes: a systematic review and meta-analysis. Implement Sci. 
2017;12(1):142. doi:10.1186/s13012-017-0670-0 
19. Rice KL, Castex J, Redmond M, Burton J, Guo JW, Beck SL. Bundling 
Interventions to Enhance Pain Care Quality (BITE Pain) in Medical Surgical 
Patients. Ochsner J. 2019;19(2):77-95. doi:10.31486/toj.18.0164 
20. Jhang JF, Kuo HC. Pathomechanism of Interstitial Cystitis/Bladder Pain Syndrome 
and Mapping the Heterogeneity of Disease. Int Neurourol J. 2016;20(Suppl 2):S95-
104. doi:10.5213/inj.1632712.356 
21. Foster HE, Hanno PM, Nickel JC, et al. Effect of amitriptyline on symptoms in 
treatment naïve patients with interstitial cystitis/painful bladder syndrome. J Urol. 
2010;183(5):1853-1858. doi:10.1016/j.juro.2009.12.106 
22. Giannantoni A, Porena M, Gubbiotti M, Maddonni S, Di Stasi SM. The efficacy and 
safety of duloxetine in a multidrug regimen for chronic prostatitis/chronic pelvic pain 
syndrome. Urology. 2014;83(2):400-405. doi:10.1016/j.urology.2013.09.024 
23. Abernethy MG, Rosenfeld A, White JR, Mueller MG, Lewicky-Gaupp C, Kenton K. 
Urinary Microbiome and Cytokine Levels in Women With Interstitial Cystitis. Obstet 
Gynecol. 2017;129(3):500-506. doi:10.1097/AOG.0000000000001892 
24. Lewis AL, Gilbert NM. Roles of the vagina and the vaginal microbiota in urinary 
tract infection: evidence from clinical correlations and experimental models. GMS 
Infect Dis. 2020;8. doi:10.3205/id000046 
25. Meriwether KV, Lei Z, Singh R, Gaskins J, Hobson DTG, Jala V. The Vaginal and 
Urinary Microbiomes in Premenopausal Women With Interstitial Cystitis/Bladder 
Pain Syndrome as Compared to Unaffected Controls: A Pilot Cross-Sectional 
Study. Front Cell Infect Microbiol. 2019;9:92. doi:10.3389/fcimb.2019.00092 
26. Dessie SG, Von Bargen E, Hacker MR, Haviland MJ, Elkadry E. A randomized, 
double-blind, placebo-controlled trial of onabotulinumtoxin A trigger point injections 
for myofascial pelvic pain. Am J Obstet Gynecol. 2019;221(5):517.e1-517.e9. 
doi:10.1016/j.ajog.2019.06.044 
27. Olson LE, Dyer JE, Haq A, Ockrim J, Greenwell TJ. A systematic review of the 
literature on cystodistension in bladder pain syndrome. Int Urogynecology J. 
2018;29(2):251-257. doi:10.1007/s00192-017-3355-y 
28. FitzGerald MP, Payne CK, Lukacz ES, et al. Randomized multicenter clinical trial of 
myofascial physical therapy in women with interstitial cystitis/painful bladder 
syndrome and pelvic floor tenderness. J Urol. 2012;187(6):2113-2118. 
doi:10.1016/j.juro.2012.01.123 

29. Keenan JE, Speicher PJ, Thacker JKM, Walter M, Kuchibhatla M, Mantyh CR. The 
Preventive Surgical Site Infection Bundle in Colorectal Surgery: An Effective 
Approach to Surgical Site Infection Reduction and Health Care Cost Savings. 
JAMA Surg. 2014;149(10):1045-1052. doi:10.1001/jamasurg.2014.346 
30. Albert H, Bataller W, Masroor N, et al. Infection prevention and enhanced recovery 
after surgery: A partnership for implementation of an evidence-based bundle to 
reduce colorectal surgical site infections. Am J Infect Control. 2019;47(6):718-719. 
doi:10.1016/j.ajic.2018.11.004 
31. Stone R, Carey E, Fader AN, et al. Enhanced Recovery and Surgical Optimization 
Protocol for Minimally Invasive Gynecologic Surgery: An AAGL White Paper. J 
Minim Invasive Gynecol. Published online August 20, 2020. 
doi:10.1016/j.jmig.2020.08.006 
32. Chaparro LE, Wiffen PJ, Moore RA, Gilron I. Combination pharmacotherapy for the 
treatment of neuropathic pain in adults. Cochrane Database Syst Rev. 
2012;(7):CD008943. doi:10.1002/14651858.CD008943.pub2 
33. Thiese MS. Observational and interventional study design types; an overview. 
Biochem Medica. 2014;24(2):199-210. doi:10.11613/BM.2014.022 
34. STROBE Statement: Available checklists. Accessed February 2, 2021. 
https://www.strobe-statement.org/index.php?id=available-checklists 
35. Brown O, Siddique M, Mou T, et al. Disparity of Racial/Ethnic Representation in 
Publications Contributing to Overactive Bladder Diagnosis and Treatment 
Guidelines. Female Pelvic Med Reconstr Surg. 2021;Publish Ahead of Print. 
doi:10.1097/SPV.0000000000000992 
36. Suresh K. An overview of randomization techniques: An unbiased assessment of 
outcome in clinical research. J Hum Reprod Sci. 2011;4(1):8-11. doi:10.4103/0974-
1208.82352 
37. REDCap. Accessed February 2, 2021. https://www.project-redcap.org/ 
38. O’Leary MP, Sant GR, Fowler FJ, Whitmore KE, Spolarich-Kroll J. The interstitial 
cystitis symptom index and problem index. Urology. 1997;49(5A Suppl):58-63. 
doi:10.1016/s0090-4295(99)80333-1 
39. Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987;30(2):191-197. 
doi:10.1016/0304-3959(87)91074-8 
40. detpdi.pdf. Accessed May 4, 2021. 
https://www.med.umich.edu/1info/FHP/practiceguides/pain/detpdi.pdf 
41. Parsons CL, Dell J, Stanford EJ, et al. Increased prevalence of interstitial cystitis: 
previously unrecognized urologic and gynecologic cases identified using a new 
symptom questionnaire and intravesical potassium sensitivity. Urology. 
2002;60(4):573-578. doi:10.1016/s0090-4295(02)01829-0 

42. Barber MD, Chen Z, Lukacz E, et al. Further validation of the short form versions of 
the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire 
(PFIQ). Neurourol Urodyn. 2011;30(4):541-546. doi:10.1002/nau.20934 
43. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a 
multidimensional self-report instrument for the assessment of female sexual 
function. J Sex Marital Ther. 2000;26(2):191-208. doi:10.1080/009262300278597 
44. Pain Catastrophizing Scale. Physiopedia. Accessed March 21, 2021. 
https://www.physio-pedia.com/Pain_Catastrophizing_Scale 
45. Tincello DG, Owen RK, Slack MC, Abrams KR. Validation of the Patient Global 
Impression scales for use in detrusor overactivity: secondary analysis of the 
RELAX study. BJOG Int J Obstet Gynaecol. 2013;120(2):212-216. 
doi:https://doi.org/10.1111/1471-0528.12069 
46. Gillman A, Zhang D, Jarquin S, Karp JF, Jeong JH, Wasan AD. Comparative 
Effectiveness of Embedded Mental Health Services in Pain Management Clinics vs 
Standard Care. Pain Med Malden Mass. 2020;21(5):978-991. 
doi:10.1093/pm/pnz294 
47. Chwa A, Kavanagh K, Linnebur SA, Fixen DR. Evaluation of methenamine for 
urinary tract infection prevention in older adults: a review of the evidence. Ther Adv 
Drug Saf. 2019;10. doi:10.1177/2042098619876749 
48. Cardenas-Trowers O, Abraham A, Dotson, Thomas, Houlette, Brooke, Gaskins J, 
Francis S. Effect of Bladder Instillations with versus without Triamcinolone 
Acetonide on Symptoms of Interstitial Cystitis/Bladder Pain Syndrome in Women: A 
Randomized Controlled Trial. 2021 Ahead Print. 
49. Lubeck DP, Whitmore K, Sant GR, Alvarez-Horine S, Lai C. Psychometric 
validation of the O’leary-Sant interstitial cystitis symptom index in a clinical trial of 
pentosan polysulfate sodium. Urology. 2001;57(6 Suppl 1):62-66. 
doi:10.1016/s0090-4295(01)01126-8