Clinical trial NCT02517996
Conditions: Interstitial Cystitis Painful Bladder Syndrome
Sponsor: Johns Hopkins University
Start date: 2015-02-01; Completion date: 2018-06-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Interstitial cystitis/Painful bladder syndrome (IC/PBS) is a chronic debilitating condition that severely impacts between 2.7 and 6.5 percent of women in the United States. Despite its public health importance the pathogenesis of IC/PBS is not well understood and there is no consensus on the optimal treatment approach for this condition. Hydrodistention is the most commonly used therapy for this condition; but it is limited by severe immediate postoperative bladder pain and its short duration of action. It has been postulated that hydrodistention works by disrupting the sensory nerves within the bladder that may be contributing to bladder pain. Recent evidence has provided support for the use of preemptive pudendal nerve block as a way to blunt immediate postoperative pain. The investigators hypothesize that preemptive pudendal nerve block prior to hydrodistention will result in lower postoperative pain after hydrodistention compared to placebo. This is a prospective double- blinded randomized study and patients will be randomized to receive preemptive bilateral pudendal nerve block with either 1% lidocaine or placebo. Bladder pain will be compared at baseline, 2 hours, 2 weeks, 6 weeks and 3 months using the Visual Analog Scale, O'Leary-Sant questionnaire and the Pelvic Pain Urgency and Frequency questionnaire.

Detailed description:
Painful bladder syndrome/interstitial cystitis (IC/PBS) is a disorder characterized by chronic bladder pain or discomfort. The exact underlying etiology of IC/PBS is unknown however several theories exist which include epithelial dysfunction, mast cell activation, and neurogenic inflammation. Whatever the underlying inciting factor for IC/PBS, the resulting phenotype is one of urinary frequency, urgency and bladder pain improved after voiding. Animal studies show that as the normal bladder fills, mechanoreceptors in the bladder wall respond to stretch through the discharge of afferent innervations or nerve firing. In normal humans, there is no conscious perception that the bladder is filling until a threshold volume is reached4. Patients with PBS/IC are thought to have substantially lower cystometric bladder volumes and a heightened sensitivity to bladder filling. Mechanoreceptors and chemoreceptors in the bladder may trigger myelinated A- delta or C-fibers found in the smooth muscle or in the submucosa in response to bladder distention. A- delta fibers are distributed mainly within the detrusor smooth muscle and are responsive to detrusor stretch that occurs during bladder filling. In contrast, C-type fibers seem to be more widespread and are distributed in the detrusor muscle, within the lamina propria and in close proximity to the urothelium. There is considerable interest in mechanisms underlying sensitization of C-fiber afferents, as these nerves are thought to play a key role in symptoms of IC/PBS. It has been shown that the plexus of afferent nerves is most dense in the regions of the bladder neck and proximal urethra. Lumbosacral afferent fibers in the pelvic and pudendal nerve, with cell bodies in the lumbosacral dorsal root ganglion (DRG), not only sense pain but also regulate continence and micturition. In laboratory animals, the pelvic nerve supply contains more stretch-responsive afferent fibers and appears to be important in responses to bladder over-distention. Neurologic changes seen after the occurrence of cystitis or other bladder insult suggest reorganization of reflex connections in the spinal cord and changes to the bladder afferents, that may suggest a greater role for the influence of the pudendal nerve on bladder pain than had been previously thought.

The pudendal nerve is a peripheral nerve that is mainly composed of afferent sensory fibers from sacral nerve roots S1, S2, and S3 and consequently it is a major contributor to bladder afferent regulation and bladder function. Pudendal nerve entrapment often leads to significant voiding dysfunction including urinary incontinence and over active bladder syndrome Furthermore, because the pudendal nerve carries such a large percentage of afferent fibers, it has been an attractive target for neuromodulation in treating refractory overactive bladder and may be useful for modulating pain experienced in IC/PBS.

No treatment has been consistently shown to provide relief in the majority of patients with painful bladder syndrome. Furthermore, combination treatment modalities are needed in the majority of patients. Cystoscopy with hydrodistention is thought to be a useful therapeutic tool in patients who are unresponsive to therapies like medication and pelvic floor physical therapy; however, its use has only been studied in a few observational studies and is currently listed as a third line treatment option for IC/PBS. According to the interstitial cystitis database study experience cystoscopy with hydrodistention is reported to be the most commonly used treatment modality for IC/PBS and published studies have reported improvement in symptoms in 70 to 80 percent of patients while other studies have reported improvement in only 40 percent. It has been postulated that hydrodistention works by disrupting the sensory nerves within the bladder that may be contributing to bladder pain and enabling the regeneration of afferent sensory nerves. Though the exact mechanism of action is unclear, there is ample evidence to suggest the efficacy of cystoscopy with hydrodistention, in a recent study by Chien-Ying et al, therapeutic hydrodistension was associated with an increase in bladder capacity and significant reduction in average O'Leary- Sant symptom and problem scores after treatment. In addition, Aihara et al who determined a positive therapeutic outcome in 71% of patients 1 month after hydrodistention have reported similar findings. The disadvantages of hydrodistention are that some patients experience a temporary worsening of their symptoms immediately following the procedure and any beneficial effect often lasts between 2-6 weeks. The immediate worsening of bladder symptoms immediately after hydrodistention and its relatively short duration of effect are often deterrents to recommending this therapy to patients. Given the multimodal approach to managing patients with IC/PBS it is imperative that the investigators explore ways to prolong the efficacy of available options and one approach that has been recently suggested is the use of preemptive analgesia.

In 1983, Woolf proposed that persistent pain experienced after trauma or surgery is due to posttraumatic functional changes not only in the peripheral pain receptors but also in the dorsal horn of the spinal cord a property known as hyperexcitability. The hyperexcitable state persists long after such stimuli cease, causing the patient to perceive pain from stimuli normally believed to be painless a common occurrence thought to be seen in patients with IC/PBS. Therefore, prevention of spinal hyperexcitability by blockade of the afferent nerve pathway from surgical site to spinal cord may therefore decrease the amount and duration of postoperative pain perception. This theory has been tested in various animal studies and was first described by Wall in 1988. In addition, the current literature on preemptive analgesia in gynecology is supportive of this approach. In a study by Ismail et al, 130 patients undergoing posterior colporrhaphy were randomized to receive preemptive pudendal nerve block with either .25% bupivacaine or normal saline. Study findings demonstrated an average postoperative Visual Analog Scale (VAS) score of 51.1 for the bupivacaine group compared to 23.5 in the placebo group. The investigators postulate that since the pudendal nerve is an important contributor to bladder afferent regulation, preemptive nerve block prior to hydrodistention may block afferent impulse transmission to the spinal cord and decrease the initial increase in postoperative bladder pain.

Arms: arm 1: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction. arm 2: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
Interventions: intervention 1: Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the brain but by stopping them before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly. intervention 2: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.

Protocol documents:
Prot_SAP_000.pdf: 
Date: 01/08/2015 
Principal Investigator: Tola Fashokun 
Application Number: IRB00034476 
NCT: 02517996 
 
Title:  
Use of Preemptive Pudendal Nerve Block Prior to Hydrodistention for the Treatment of Interstitial 
Cystitis/Painful Bladder Syndrome (IC/PBS) 


 
 
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Version 3 Dated:   06/2007 
 
Page 1 of 10 
 
Date: 1-8-15 
Principal Investigator: Tola Fashokun 
Application Number: IRB00034476 
 
 
 
 
JHM IRB - eForm A – Protocol 
 
 
 
• 
Use the section headings to write the JHM IRB eForm A, inserting the appropriate material in each. If 
a section is not applicable, leave heading in and insert N/A. 
• 
When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at the top 
of JHM IRB eForm A. 
 
********************************************************************************************** 
 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research hypothesis, 
and the importance of the research. 
 
Interstitial cystitis/Painful bladder syndrome (IC/PBS) is a chronic debilitating condition that severely impacts 
between 2.7 and 6.5 percent of women in the United States. Despite its public health importance the pathogenesis of 
IC/PBS is not well understood and there is no consensus on the optimal treatment approach for this condition. 
Hydrodistention is the most commonly used therapy for this condition; but it is limited by severe immediate 
postoperative bladder pain and its short duration of action. It has been postulated that hydrodistention works by 
disrupting the sensory nerves within the bladder that may be contributing to bladder pain. Recent evidence has 
provided support for the use of preemptive pudendal nerve block as a way to blunt immediate postoperative pain. We 
hypothesize that preemptive pudendal nerve block prior to hydrodistention will result in lower postoperative pain 
after hydrodistention compared to placebo. This is a prospective double- blinded randomized study and patients will 
be randomized to receive preemptive bilateral pudendal nerve block with either 1% lidocaine or placebo. Bladder 
pain will be compared at baseline, 2 hours, 2 weeks, 6 weeks and 3 months using the Visual Analog Scale, O’Leary-
Sant questionnaire and the Pelvic Pain Urgency and Frequency questionnaire.  
 
 
2. 
Objectives (include all primary and secondary objectives) 
 
Our overall goal is to determine the change in bladder symptoms after preemptive pudendal nerve block before 
hydrodistention in patients with IC/PBS. In order to effectively characterize our outcomes we have chosen different 
validated instruments to assess post-operative pain. First, in order to objectively quantify pain intensity we will 
determine the mean difference in postoperative pain at 2 hours in the treatment group (1% Lidocaine) compared to 
the placebo group (saline) using the Visual Analog Scale (VAS); this will serve as our primary endpoint (AIM 1). In 
order to capture the most important voiding and pain symptoms and to assess the degree of bother between the two 
groups we will measure mean difference in interstitial cystitis symptom index and the problem index (O’Leary-Sant) 
and in the Pelvic pain, Urgency and Frequency (PUF) questionnaire at baseline, 2 hours, 2 weeks, 6 weeks and 3 
months after treatment with hydrodistention and preemptive pudendal nerve block compared to hydrodistention with 
placebo (AIM 2). Finally in an attempt to expand our knowledge about the change in bladder symptoms over time, 
we will measure the change in the interstitial cystitis symptom index and the problem index (O’Leary-Sant) and in 
the Pelvic pain, Urgency and Frequency (PUF) questionnaire at baseline, 2 hours, 2 weeks, 6 weeks and 3 months 


 
 
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after treatment (AIM3). With this project we propose a novel approach to decreasing the immediate postoperative 
pain and possibly prolonging the efficacy of this intervention for the management of IC/PBS.  
 
Aim 1. To determine the mean difference in pain at 2 hours postoperatively in patients undergoing hydrodistention 
with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline) using the 
visual analog scale (VAS). 
AIM 2. To determine the mean difference in interstitial cystitis symptom index and the problem index (O’Leary-
Sant) and in the Pelvic pain, Urgency and Frequency (PUF) questionnaire at baseline, 2 hours, 2 weeks, 6 weeks and 
3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention 
with placebo (saline). 
AIM 3. To measure the change in the interstitial cystitis symptom index and the problem index (O’Leary-Sant) and 
in the Pelvic pain, Urgency and Frequency (PUF) questionnaire at baseline, 2 hours, 2 weeks, 6 weeks and 3 months 
after treatment with hydrodistention with and without preemptive pudendal nerve block. 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, drug or 
device, and any other relevant information to justify the research) 
 
Painful bladder syndrome/interstitial cystitis (IC/PBS) is a disorder characterized by chronic bladder pain or 
discomfort1. The exact underlying etiology of IC/PBS is unknown however several theories exist which include 
epithelial dysfunction, mast cell activation, and neurogenic inflammation. Whatever the underlying inciting factor for 
IC/PBS, the resulting phenotype is one of urinary frequency, urgency and bladder pain improved after voiding1. 
Animal studies show that as the normal bladder fills, mechanoreceptors in the bladder wall respond to stretch through 
the discharge of afferent innervations or nerve firing 2,3. In normal humans, there is no conscious perception that the 
bladder is filling until a threshold volume is reached4. Patients with PBS/IC are thought to have substantially lower 
cystometric bladder volumes and a heightened sensitivity to bladder filling5. Mechanoreceptors and chemoreceptors 
in the bladder may trigger myelinated A- delta or C-fibers found in the smooth muscle or in the submucosa in 
response to bladder distention. A- delta fibers are distributed mainly within the detrusor smooth muscle and are 
responsive to detrusor stretch that occurs during bladder filling. In contrast, C-type fibers seem to be more 
widespread and are distributed in the detrusor muscle, within the lamina propria and in close proximity to the 
urothelium4, 5, 6. There is considerable interest in mechanisms underlying sensitization of C-fiber afferents, as these 
nerves are thought to play a key role in symptoms of IC/PBS. It has been shown that the plexus of afferent nerves is 
most dense in the regions of the bladder neck and proximal urethra4. Lumbosacral afferent fibers in the pelvic and 
pudendal nerve, with cell bodies in the lumbosacral DRG, not only sense pain but also regulate continence and 
micturition 6,7,8. In laboratory animals, the pelvic nerve supply contains more stretch-responsive afferent fibers and 
appears to be important in responses to bladder over-distention. Neurologic changes seen after the occurrence of 
cystitis or other bladder insult suggest reorganization of reflex connections in the spinal cord and changes to the 
bladder afferents, that may suggest a greater role for the influence of the pudendal nerve on bladder pain than had 
been previously thought 8,9.  
 
The pudendal nerve is a peripheral nerve that is mainly composed of afferent sensory fibers from sacral nerve roots 
S1, S2, and S3 and consequently it is a major contributor to bladder afferent regulation and bladder function. 
Pudendal nerve entrapment often leads to significant voiding dysfunction including urinary incontinence and over 
active bladder syndrome 10,11 Furthermore, because the pudendal nerve carries such a large percentage of afferent 
fibers, it has been an attractive target for neuromodulation in treating refractory overactive bladder and may be useful 
for modulating pain experienced in IC/PBS12,13, 14.  
 
No treatment has been consistently shown to provide relief in the majority of patients with painful bladder 
syndrome14. Furthermore, combination treatment modalities are needed in the majority of patients. Cystoscopy with 
hydrodistention is thought to be a useful therapeutic tool in patients who are unresponsive to therapies like 
medication and pelvic floor physical therapy; however, its use has only been studied in a few observational studies 
and is currently listed as a third line treatment option for IC/PBS1, 14,15. According to the interstitial cystitis database 


 
 
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Page 3 of 10 
 
study experience cystoscopy with hydrodistention is reported to be the most commonly used treatment modality for 
IC/PBS and published studies have reported improvement in symptoms in 70 to 80 percent of patients while other 
studies have reported improvement in only 40 percent14. It has been postulated that hydrodistention works by 
disrupting the sensory nerves within the bladder that may be contributing to bladder pain and enabling the 
regeneration of afferent sensory nerves16. Though the exact mechanism of action is unclear, there is ample evidence 
to suggest the efficacy of cystoscopy with hydrodistention, in a recent study by Chien-Ying et al, therapeutic 
hydrdistension was associated with an increase in bladder capacity and significant reduction in average O’Leary- 
Sant symptom and problem scores after treatment16. In addition, Aihara et al who determined a positive therapeutic 
outcome in 71% of patients 1 month after hydrodistention have reported similar findings17. The disadvantages of 
hydrodistention are that some patients experience a temporary worsening of their symptoms immediately following 
the procedure and any beneficial effect often lasts between 2-6 weeks18, 19,21,22. The immediate worsening of bladder 
symptoms immediately after hydrodistention and its relatively short duration of effect are often deterrents to 
recommending this therapy to patients. Given the multimodal approach to managing patients with IC/PBS it is 
imperative that we investigate ways to prolong the efficacy of available options and one approach that has been 
recently suggested is the use of preemptive analgesia.  
 
In 1983, Woolf proposed that persistent pain experienced after trauma or surgery is due to posttraumatic functional 
changes not only in the peripheral pain receptors but also in the dorsal horn of the spinal cord a property known as 
hyperexcitability23. The hyperexcitable state persists long after such stimuli cease, causing the patient to perceive 
pain from stimuli normally believed to be painless a common occurrence thought to be seen in patients with IC/PBS. 
Therefore, prevention of spinal hyperexcitability by blockade of the afferent nerve pathway from surgical site to 
spinal cord may therefore decrease the amount and duration of postoperative pain perception24. This theory has been 
tested in various animal studies and was first described by Wall in 1988. In addition, the current literature on 
preemptive analgesia in gynecology is supportive of this approach25, 26.  In a study by Ismail et al, 130 patients 
undergoing posterior colporrhaphy were randomized to receive preemptive pudendal nerve block with either .25% 
bupivacaine or normal saline. Study findings demonstrated an average postoperative VAS score of 51.1 for the 
bupivacaine group compared to 23.5 in the placebo group. We postulate that since the pudendal nerve is an important 
contributor to bladder afferent regulation, preemptive nerve block prior to hydrodistention may block afferent 
impulse transmission to the spinal cord and decrease the initial increase in postoperative bladder pain. 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures (distinguish research procedures 
from those that are part of routine care). 
 
This study is a prospective double-blinded randomized controlled study that will be done at two sites: Johns Hopkins 
Bayview Medical Center and Greater Baltimore Medical Center.  Female patients over 18 years of age, who present 
for treatment of painful bladder syndrome (IC/PBS) at the Pelvic Floor Center at the Johns Hopkins Bayview 
Medical Center, will be considered for inclusion in the study (please see below for inclusion and exclusion criteria). 
The primary investigator and co-investigators will determine patient eligibility. The patients will be asked to 
participate in the study if they are undergoing cystoscopy with hydrodistention for a presumed diagnosis of IC/PBS.  
When the patient presents to the operating room on the day of their scheduled surgery they will be asked to complete 
the PUF questionnaire, the interstitial cystitis symptom and problem index, and the Visual Analog Scale (VAS). This 
time point has been chosen to minimize the temporal variation seen in pain.  Patients will be randomized to either 
preemptive bilateral pudendal nerve block with either 20 cubic centimeters 1% lidocaine or 20 cubic centimeters 
normal saline after anesthesia induction, participants will be stratified by type of anesthesia. The circulating nurse 
will be provided with a sealed opaque envelope with the patient group allocation and he/she will provide the 
operating surgeon with the study drug in a syringe labeled “pudendal nerve block”.  The placement of the pudendal 
nerve block will be performed in a standardized fashion per protocol. The patients will receive their standardized 
anesthetic regiment per anesthesiology guidelines. At the conclusion of the case the patients will be monitored in the 
postoperative anesthesia unit for recovery per nursing guidelines. The patients will be asked to rate their pain on a 
100mm VAS, the O’Leary Sant, and the PUF at 2 hours postoperatively. 


 
 
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b. Study duration and number of study visits required of research participants. 
 
The interstitial cystitis symptom index and the problem index and PUF questionnaire and VAS will be repeated at 2 
hours, 2 weeks, 6 weeks and 3 months postoperatively via a telephone interview. These time points have been 
specifically chosen due to their common use as intervals for assessing pain. Additionally, the expected difference in 
pain intensity for these time intervals is well described in the literature17. Furthermore, the mean duration of action of 
cystoscopy with hydrodistention is reported to last between 2 and 6 weeks, and we will be certain to capture evidence 
of prolonged efficacy if study follow up is extended to 3 months post operatively17, 18, 19.  
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Randomization to 1% Lidocaine versus placebo will be performed using computer or hand generated 1:1 block 
permutations and stratified by anesthesia type. Assignment will be revealed in the operating room after the patient 
receives anesthesia. We will randomize 120 patients total (60 at each site, 30 for placebo and 30 for treatment). 
 
d. Justification of why participants will not receive routine care or will have current therapy stopped. 
 
Currently, hydrodistention is routinely done without pudendal nerve block. This study will introduce an addition to 
standard care that may alleviate postoperative pain.  
 
e. Justification for inclusion of a placebo or non-treatment group. 
 
This study requires a placebo as this will allow for a comparison group, will enable us to account for a placebo effect 
and potential bias.  However, both groups will be receiving standard treatment, which is hydrodistention. 
 
f. Definition of treatment failure or participant removal criteria. 
 
Participants may be removed from the study if they are diagnosed/newly recognized to meet any of the exclusion 
criteria, including intolerance of local anesthesia, new bleeding disorder, or new onset mental status change that 
precludes the patient from being be able to follow instructions or accurately assess pain control.  
 
g. Description of what happens to participants receiving therapy when study ends or if a participant’s 
participation in the study ends prematurely. 
 
At the completion of the study if patients receive a significant improvement in their symptoms after hydrodistention 
and pudendal nerve block then they will continue to be managed with this therapy in the future. If they do not receive 
benefit or their participation ends prematurely they will be offered alternative therapies to treat their IC/PBS 
symptoms. 
 
 
5. 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria:  All women aged greater than 18 years of age scheduled to undergo cystoscopy with 
hydrodistention who are literate, English speaking and can provide written informed consent will be included in this 
study.  
Exclusion Criteria: Patients who have intolerance or known allergies to local analgesia will be excluded. In 
addition, patients who have coagulation disorders will also be excluded as this may increase their risks of 
complication from bleeding. Patient will also be excluded if they have a history of dementia as this may impair their 
ability to follow instructions. Patients who are non-ambulatory and who have an inability to fully assess pain will 


 
 
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also be excluded.  Patients receiving additional surgical procedures will be excluded from the study, as the source of 
their pain may be difficult to decipher in the immediate post-operative period.  
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, 
block and surface anesthesia, It is characterized by a rapid onset of action, intermediate duration of efficacy, and its 
elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage 
gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation31. With 
sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit 
an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the 
brain but by stopping them before they begin. Adverse drug reactions are rare when lidocaine is used as a local 
anesthetic and when administered correctly27.  
 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA approved 
indications or if doses or routes of administration or participant populations are changed.  n/a 
 
c. Justification and safety information if non-FDA approved drugs without an IND will be administered. 
n/a 


 
 
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Date: 4/14/2014   
Principal Investigator: Tola Fashokun 
Application Number: IRB00034476 
 
 
7. 
Study Statistics 
a. Primary outcome variable. 
 
Visual Analog Scale (VAS): The most common VAS consists of a 100mm horizontal or vertical line with the two 
endpoints labeled "no pain" and "worst pain ever" (or similar verbal descriptors). Patients are required to place a 
mark on the 100mm line at a point that corresponds to the level of pain intensity they feel. The distance in 
centimeters from the low end of the VAS to the patient's mark is used as a numerical index of the severity of pain28. 
Pain scores of 30–54 mm are regarded as moderate while a score over 54 indicates severe pain28,29.  
Visual analog scales are sensitive to pharmacologic and non-pharmacologic procedures that alter the experience of 
pain and correlate highly with pain measured on verbal and numeric rating scales. A major advantage of the VAS as 
a measure of sensory pain intensity is its ratio scale properties. In contrast to many other pain-measurement tools, 
equality of ratios is implied, making it appropriate to speak meaningfully about percentage differences between VAS 
measurements obtained at multiple points in time or from independent samples of subjects. Other advantages of the 
VAS include its ease and brevity of administration, scoring and minimal intrusiveness; and, providing that 
adequately clear instructions are given to patients, its conceptual simplicity30,. 
 
b. Secondary outcome variables. 
 
The interstitial cystitis symptom index and the problem index (O’Leary-Sant):  
The interstitial cystitis symptom index and the problem index have been designed to capture the most important 
voiding and pain symptoms and to assess how problematic patients find them in the clearest and most concise 
manner possible31. Both instruments have been designed and validated for self-administration, so that trained 
interviewers are not needed to use them. This is a unique tool that will enable us to monitor symptom regression and 
efficacy of our treatment.  
 
Pelvic Pain, Urgency and Frequency (PUF) questionnaire:  
The PUF questionnaire is a commonly used measure for evaluating patients suspected of having IC/PBS. Its domains 
address what are considered the hallmarks of the disease, namely pain, urinary urgency, and frequency of urination32. 
Parsons et al. initially examined the value of the PUF questionnaire as a predictive diagnostic tool in 2002. In this 
study, a direct correlation was found between greater PUF scores and the likelihood of a positive PST in patients with 
suspected IC/PBS and gynecologic pain33. Since then the PUF questionnaire has been considered a valid diagnostic 
screening tool for patients with possible IC/PBS and will be the tool used in this study for that purpose. 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
Recent evidence suggests a significant difference in 2-hour postoperative mean VAS scores after preemptive 
analgesia with 1% lidocaine (50.1±27.9) compared to placebo (70.6 ± 22.6 ) 34. Based on this estimated mean 
difference we are planning this study with 50 participants (n= 50). The Type I error probability associated with the 
test of this null hypothesis is 0.05, with a power of 80%. Demographic, surgical, and clinical outcomes will be 
assessed using t-test, chi squared, and Fisher exact tests where appropriate. For continuous measures, normally 
distributed data will be compared with Students t test; non-normally distributed data will be compared with Wilcoxon 
test. Visual analog pain scores will be compared using repeated measures of variance. Furthermore, an intention to 
treat analysis will be performed for the participants who drop out prior to study completion.  
 
d. Early stopping rules. 


 
 
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e. Participants who no longer wish to be a part of the study may stop without penalty at any time during the 
study.  
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
There is minimal risk involved in performing pudendal nerve blocks, these risk include a less than 1% chance of 
additional pain, bleeding, hematoma or lidocaine systemic toxicity.  
 
b. Steps taken to minimize the risks. 
In order to minimize risk the pudendal nerve block will be performed by a trained urogynecologist in the operating 
room, additionally the patients will be monitored by an anesthesiologist during the procedure for any signs of 
systemic toxicity. 
The participants will also be monitored in the postoperative recovery area for 2 hours after their procedure.  
 
c. Plan for reporting unanticipated problems or study deviations. 
 
All unanticipated problems and study deviations will be reported to the IRB at regular intervals.   
 
d. Legal risks such as the risks that would be associated with breach of confidentiality.  
The legal risks of this procedure are similar to other surgical interventions: there is a risk of bleeding, infection, 
damage to surrounding structures, or failure to obtain desired result. There are also risks associated with 
confidentiality if patient information were not to be appropriately transferred during the course of the procedure.  
e. Financial risks to the participants. 
 
Financial risks to participants are significant for lost work time, including recuperation. These are not considered to 
be significantly different compared to the current standard of care for execution of pudendal nerve block. 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
Pudendal nerve blocks are widely performed in Obstetrics and Gynecology. The procedure involves injecting local 
anesthetic around the trunk of the pudendal nerve located behind the sacrospinous ligament. Infiltration of local 
anesthesia at the site of the pudendal nerve leads to analgesia at the areas being innervated by sacral nerve roots two, 
three and four.. Recent improvement in our understanding of pain management in other specialties have provided us 
with insight on how to blunt the immediate increase in bladder pain seen after hydrodistention and prolong the effect 
of this therapy on patients with IC/PBS. Following surgery, afferent impulses centrally processed can increase 
postsurgical pain26. Preemptive analgesia is an intervention provided prior to the initiation of painful stimuli, which 
may reduce or blunt subsequent pain in the postoperative period 35,36 ,37,38.The use of pudendal nerve blocks in 
combination with hydrodistention may allow us to improve the immediate efficacy of this treatment modality and 
also prolong the duration of action of this therapy. Currently there are no studies evaluating the use of pudendal nerve 
blocks with hydrodistention for the treatment of painful bladder syndrome.  
 
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, and any 
proposed reductions or penalties for not completing the protocol. 
 
We will not be offering compensation to patients participating in this protocol.  
 
11. 
Costs 


 
 
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a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify who will 
pay for them. 
 
There will not be cost associated with participation from our participants.  
 
References: 
 
1.Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; 
Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA 
guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun; 185(6): 
2162-70 
 
2.De Groat R.C. Nervous control of the urinary bladder of the cat. Brain Res. 87 (1975) 201-211. 
 
3.Garry R.C, Roberts T.D.M, Todd J.K, Reflexes involving the external urethral sphincter in the cat, J. Physiol. 149 
(1959) 653 – 665. 
 
4. Birder L, de Groat W, Mills I, Morrison J, Thor K, Drake M. 
Neural control of the lower urinary tract: peripheral and spinal mechanisms. Neurourol Urodyn. 2010; 29(1): 128-39 
 
5. Kuo YC, Kuo HC.The urodynamic characteristics and prognostic factors of patients with interstitial 
cystitis/bladder pain syndrome. Int J Clin Pract. 2013 Sep; 67(9): 863-9.  
 
6. Malykhina AP. Neural mechanisms of pelvic organ cross-sensitization. 
Neuroscience 2007; 149:660 – 72. 
 
7. Pezzone MA, Liang R, Fraser MO. A model of neural cross talk and irritation 
In the pelvis: Implications for the overlap of chronic pelvic pain disorders. 
Gastroenterology 2005; 128:1953 – 64. 
 
8. Bruns TM, Weber DJ, Gaunt RA. Microstimulation of afferents in the sacral dorsal root ganglia can evoke reflex 
bladder activity. Neurourol Urodyn. 2014 Jan 24. 
 
9. Tai C, Wang J, Wang X, et al. Bladder inhibition or voiding induced by pudendal nerve stimulation in chronic 
spinal cord injured cats. Neurourol Urodyn 2007; 26:570 – 7. 
 
10. McGee MJ, Grill WM. Selective co-stimulation of pudendal afferents enhances bladder activation and improves 
voiding efficiency. Neurourol Urodyn. 2013 Aug 9 
 
11. Possover M, Forman A. Voiding Dysfunction Associated with Pudendal Nerve Entrapment. Curr Bladder 
Dysfunct Rep. 2012 Dec; 7(4): 281-285.  
 
 
12.Chronic pudendal neuromodulation: expanding available treatment options for refractory urologic symptoms. 
Peters KM, Killinger KA, Boguslawski BM, Boura JA. 
 
13. Wang S, Zhang S, Zhao L. Long-term efficacy of electrical pudendal nerve stimulation for urgency-frequency 
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14.  Rovner E, Propert KJ, Brensinger C, et al. Treatments used in women with interstitial cystitis: the interstitial 
cystitis data base (ICDB) study experience. The Interstitial Cystitis Data Base Study Group. Urology. 2000; 56(6): 
940. 
 
15. Ottem DP and Teichman JM: What is the value of cystoscopy with hydrodistention for interstitial cystitis? 
Urology 2005; 66: 494. 
 
16. Wu, C. Y., Chen, I., & Tong, Y. C. (2013). Long-term treatment outcomes in patients with interstitial 
cystitis/painful bladder syndrome: 10-year experience in NCKUH. Urological Science, 24(1), 10-13. 
 
17. Aihara, K., Hirayama, A., Tanaka, N., Fujimoto, K., Yoshida, K., & Hirao, Y. (2009). Hydrodistention under 
local anesthesia for patients with suspected painful bladder syndrome/interstitial cystitis: safety, diagnostic potential 
and therapeutic efficacy. International Journal of Urology, 16(12), 947-952. 
 
18. Davis NF, Brady CM, Creagh T.Interstitial cystitis/painful bladder syndrome: epidemiology, pathophysiology 
and evidence-based treatment options. 
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19  Hsieh CH, Chang ST, Hsieh CJ, et al. Treatment of interstitial cystitis with hydrodistention and bladder training. 
Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(10):1379. 
 
20. Adjuvant hydrodistention under epidural anesthesia for interstitial cystitis. 
Yamada T1, Murayama T, Andoh M. 
 
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23. Woolf CJ. Evidence for a central component of post-injury pain hypersensitivity. Nature 1983;306:686–8 
 
24. Ke, R. W., Portera, S. G., Bagous, W., & Lincoln, S. R. A randomized, double-blinded trial of preemptive 
analgesia in laparoscopy. Obstetrics & Gynecology 1998, 92(6), 972-975. 
 
25. Ismail MT, Elshmaa NS. Pre-emptive analgesia by nerve stimulator guided pudendal nerve block for posterior 
colpoperineorrhaphy. Eur J Obstet Gynecol Reprod Biol. 2012 Apr 27. 
 
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in vaginal Surgery. Int Urogynecol J (2009) 20:5–10 
 
27. Wolfe JW, Butterworth JF. Local anesthetic systemic toxicity: update on mechanisms and treatment. Current 
Opinion in Anaesthesiology. 24(5):561-566, October 2011. 
 
28. DeLoach LJ, Higgins MS, Caplan AB, et al. The visual analog scale in the immediate postoperative period: 
intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan; 86(1):102-6. 
 
29. Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in 
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problem index. Urology. 1997 May;49(5A Suppl):58-63. 
 
32. Brewer ME, White WM, Klein FA, Klein LM, Waters WB.Validity of Pelvic Pain, Urgency, and Frequency 
questionnaire in patients with interstitial cystitis/painful bladder syndrome. Urology. 2007 Oct;70(4):646-9.  
 
33. Parsons CL, Dell J, Stanford EJ., et al. Increased prevalence of interstitial cys- titis: Previously unrecognized 
urologic and gynecologic cases identified using a new symptom questionnaire and intravesical potassium sensitivity. 
Urology 2002;60:573–8 
 
34. Lior Lowenstein, Etan Z. Zimmer , Michael Deutsch, Yuri Paz, Dina Yaniv, Peter Jakobi. Preoperative analgesia 
with local lidocaine infiltration for abdominal hysterectomy pain management. European Journal of Obstetrics & 
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35. O'Neal MG1, Beste T, Shackelford DP. Utility of preemptive local analgesia in vaginal hysterectomy. Am J 
Obstet Gynecol 2003;189:1539-42. 
36. Katz J, Melzack R. Measurement of pain. Surg Clin North Am (1999) 79(2): 231-252 
 
37. Joel Katz, Colin J.L. McCartney. Current status of pre-emptive analgesia Current Opinion Anaesthesiology 
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ICF_001.pdf: 
Date: 10/18/2016  
Principal Investigator: Tola Fashokun  
Application Number: IRB00034476  
NCT: 02517996  
  
Title:   
Use of Preemptive Pudendal Nerve Block Prior to Hydrodistention for the Treatment of Interstitial 
Cystitis/Painful Bladder Syndrome (IC/PBS) 


 
Approved October 18, 2016 
Date: October 18, 2016 
Principal Investigator: Tola Fashokun, MD 
Application No.: IRB00034476: 
 
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Combined Informed Consent/Authorization June 2015 Version 15 
 
 
 
 
 
 
 
 
 
RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY 
AUTHORIZATION FORM 
 
Protocol Title:  
Impact of preemptive analgesia on hydrodistension for painful 
bladder syndrome/interstitial cystitis 
 
Application No.:  
IRB00034476 
 
Principal Investigator: Tola Fashokun, MD 
301 Building, 3rd Floor, Room 3123A  
4940 Eastern Ave  
Baltimore MD, 21224  
Phone: 410-550-2787,  Fax: 410-550-2786  
 
1. 
What you should know about this study: 
• You are being asked to join a research study. This consent form explains the research study and your 
part in it. Please read it carefully and take as much time as you need. Ask your study doctor or the 
study team to explain any words or information that you do not understand. 
• You are a volunteer.  If you join the study, you can change your mind later.  There will be no penalty 
or loss of benefits if you decide to quit the study.   
• During the study, we will tell you if we learn any new information that might affect whether you 
wish to continue to participate. 
• If we think your participation in this study may affect your clinical care, information about your 
study participation will be included in your medical record, which is used throughout Johns Hopkins.   
Doctors outside of Johns Hopkins may not have access to this information.  You can ask the research 
team to send this information to any of your doctors. 
• When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, The 
Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital, 
Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital and All 
Children’s Hospital.  
• A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law.  This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time.  
• If you would like to review the information for this study, or a summary of the results, ask the study 
team doctor for the ClinicalTrials.gov study registration number. 
• During this study, you will not have access to certain medical information and test results collected 
for study purposes.  If an emergency occurs while you are in the study, medical information needed 
for your treatment can be made available to your study physician and other physicians who treat you.  
When the study is completed, all the information in your medical record will be available to you. 
If you are using Epic for this study, fax a copy 
of the signed consent form to 410-367-7382. 
 
 
 
 
 
Patient I.D. plate 
 


 
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2. 
Why is this research being done? 
This research is being done to compare if using a local anesthetic or saline results in less pain when 
giving a nerve block to numb the pudendal nerves, which supply feeling to the pelvis, after cystoscopy 
in patients with Interstitial Cystitis. We also want to determine if there is a change in bladder symptoms 
after numbing the pudendal nerves, , before cystoscopy with hydrodistension.  
 
Women aged greater than 18 years of age who are not pregnant and scheduled to undergo cystoscopy 
with hydrodistension may join this study.  
 
How many people will be in this study? 
About 50 women will be a part of this study.  
 
3. 
What will happen if you join this study? 
If you agree to be in this study, we will ask you to do the following things: 
 
• You will be randomly (by chance, like the flip of a coin) selected to have a pudendal nerve block 
with a local anesthetic or with saline at the time of your cystoscopy with hydrodistension.  
• This is a double-blinded study, which means neither you nor your doctor will know to which 
study group you were assigned (local anesthetic or saline).  In case of an emergency, your study 
doctor can find out this information. 
 
• You will also be asked to complete questionnaires about your symptoms before the procedure 
and 2 hours, 2 weeks, 6 weeks, and 3 months after the procedure.  
 
How long will you be in the study? 
You will be in this study for three months (12 weeks).  
 
4. 
What are the risks or discomforts of the study? 
There is minimal risk involved in performing pudendal nerve blocks, these risk include a less than 1% 
chance of additional pain, bleeding, bruising or lidocaine systemic toxicity. In order to minimize risk the 
pudendal nerve block will be performed by a trained physician in the operating room, additionally you 
will be monitored by an anesthesiologist during the procedure for any signs of toxicity. You will also be 
monitored in the postoperative recovery area for 2 hours after your procedure. Your confidential 
information is blinded and password protected.  
 
You may get tired or bored when we are asking you questions or you are completing questionnaires. 
You do not have to answer any question you do not want to answer. 
 
There may be side effects and discomforts that are not yet known.   
 
5. 
Are there risks related to pregnancy? 
Due to the nature of this intervention, women who are pregnant are not eligible for this study, however, 
an injection of lidocaine carries a very low risk of side effects to a fetus.  
 
6. 
Are there benefits to being in the study? 
Using a pudendal nerve block in combination with hydrodistention may allow us to improve the 
immediate effect of this treatment and also prolong the duration of action of this therapy. 
 
If you take part in this study, you may help others in the future. 


 
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7. 
What are your options if you do not want to be in the study? 
You do not have to join this study.  If you do not join, your care at Johns Hopkins will not be affected. 
 
8. 
Will it cost you anything to be in this study?   
You will receive a separate Insurance and Research Participant Financial Responsibility Information 
Sheet (Sheet).  
 
This Sheet will give you the following information: 
• The procedures, tests, drugs or devices that are part of this research and that will be paid for by 
the study (no cost to you).   
• The procedures, tests, drugs or devices that will be billed to you and/or your health insurer.  If 
you have health insurance, you will be responsible for any co-pays or deductibles not covered by 
your insurance. 
 
9. 
Will you be paid if you join this study? 
No.  
 
10. 
Can you leave the study early? 
• You can agree to be in the study now and change your mind later. 
• If you wish to stop, please tell us right away. 
• Leaving this study early will not stop you from getting regular medical care.  
 
If you leave the study early, Johns Hopkins may use or give out your health information that it has 
already collected if the information is needed for this study or any follow-up activities.  
 
11. 
Why might we take you out of the study early?  
You may be taken out of the study if: 
• Staying in the study would be harmful. 
• You need treatment not allowed in the study. 
• You fail to follow instructions. 
• You become pregnant. 
• The study is cancelled. 
• There may be other reasons to take you out of the study that we do not know at this time.  
 
If you are taken out of the study early, Johns Hopkins may use or give out your health information that it 
has already collected if the information is needed for this study or any follow-up activities. 
 
12. 
How will your privacy be protected?  
We have rules to protect information about you.  Federal and state laws and the federal medical Privacy 
Rule also protect your privacy.  By signing this form you provide your permission, called your 
“authorization,” for the use and disclosure of information protected by the Privacy Rule. 
 
The research team working on the study will collect information about you.  This includes things learned 
from the procedures described in this consent form.  They may also collect other information including 
your name, address, date of birth, and information from your medical records (which may include 
information about HIV status, drug, alcohol or STD treatment, genetic test results, or mental health 
treatment). 
 


 
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The research team will know your identity and that you are in the research study.  Other people at Johns 
Hopkins, particularly your doctors, may also see or give out your information. We make this information 
available to your doctors for your safety.    
 
People outside of Johns Hopkins may need to see or receive your information for this study.  Examples 
include government agencies (such as the Food and Drug Administration), safety monitors, other sites in 
the study and companies that sponsor the study.  
 
If you are in a cancer study that receives federal funding, the National Cancer Institute (NCI) now 
requires that we report identifiable information (such as, zip code) about your participation.  You may 
contact the NCI if you have questions about how this information is used.  
 
We cannot do this study without your authorization to use and give out your information.  You do not 
have to give us this authorization.  If you do not, then you may not join this study. 
 
We will use and disclose your information only as described in this form and in our Notice of Privacy 
Practices; however, people outside Johns Hopkins who receive your information may not be covered by 
this promise or by the federal Privacy Rule.  We try to make sure that everyone who needs to see your 
information keeps it confidential – but we cannot guarantee that your information will not be re-
disclosed. 
 
The use and disclosure of your information has no time limit. You may revoke (cancel) your permission 
to use and disclose your information at any time by notifying the Principal Investigator of this study by 
phone or in writing.  If you contact the Principal Investigator by phone, you must follow-up with a 
written request that includes the study number and your contact information.  The Principal 
Investigator’s name, address, phone and fax information are on page one of this consent form.  
 
If you do cancel your authorization to use and disclose your information, your part in this study will end 
and no further information about you will be collected. Your revocation (cancellation) would not affect 
information already collected in the study, or information we disclosed before you wrote to the Principal 
Investigator to cancel your authorization. 
 
13. 
Will the study require any of your other health care providers to share your health 
information with the researchers of this study? 
As a part of this study, the researchers may ask to see your health care records from your other health 
care providers.   
 
14. 
What treatment costs will be paid if you are injured in this study?  
Johns Hopkins does not have a program to pay you if you are hurt or have other bad results from being 
in the study.  However, medical care at Johns Hopkins is open to you as it is to all sick or injured people.   
 
The costs for any treatment or hospital care you receive as the result of a study-related injury that are not 
covered by a health insurer will be billed to you. 
 
By signing this form you will not give up any rights you have to seek compensation for injury.  
 
 
 
 
 


 
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15. 
What other things should you know about this research study? 
a. What is the Institutional Review Board (IRB) and how does it protect you?  
The Johns Hopkins Medicine IRB is made up of: 
• Doctors 
• Nurses 
• Ethicists 
• Non-scientists 
• and people from the local community.  
 
The IRB reviews human research studies. It protects the rights and welfare of the people taking part 
in those studies.  You may contact the IRB if you have questions about your rights as a participant or 
if you think you have not been treated fairly.  The IRB office number is 410-955-3008. You may 
also call this number for other questions, concerns or complaints about the research. 
 
When the Johns Hopkins School of Medicine Institutional Review Board (IRB) reviews a study at 
another site, that site (institution) is solely responsible for the safe conduct of the study and for 
following the protocol approved by the Johns Hopkins IRB.   
 
If you are a participant at Greater Baltimore Medical Center, you may contact James Mersey, M.D. 
(Chairman of the GBMC IRB) at 410-828-7417. 
 
b. What do you do if you have questions about the study?    
Call the principal investigator, Dr. Tola Fashokun at 410-550-2787. If you wish, you may contact the 
principal investigator by letter or by fax.  The address and fax number are on page one of this 
consent form. If you cannot reach the principal investigator or wish to talk to someone else, call the 
IRB office at 410-955-3008.  
 
c. What should you do if you are  injured or ill as a result of being in this study?  
If you think you are injured or ill because of this study, call Principal Investigator Tola Fashokun at 
410-550-2787 during regular business hours.  
 
If you have an urgent medical problem related to your taking part in this study, , call Tola 
Fashokun at 410-550-2787during regular office hours and please call 911 in case of an acute 
emergency.   
 
d. What happens to Data that are collected in the study?  
Johns Hopkins and our research partners work to understand and cure diseases. The data you provide 
are important to this effort. 
 
If you join this study, you should understand that you will not own your data, and should researchers 
use them to create a new product or idea, you will not benefit financially.  
 
 


 
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16. 
What does your signature on this consent form mean?  
Your signature on this form means that: You understand the information given to you in this form, you 
accept the provisions in the form and you agree to join the study. You will not give up any legal rights 
by signing this consent form.  
 
 
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM 
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Participant                                                                           (Print Name)                                                 
 
Date/Time  
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Person Obtaining Consent                                                  (Print Name)                                               
 
Date/Time 
 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR; A COPY MUST BE GIVEN 
TO THE PARTICIPANT; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE FAXED TO 410-367-7382; IF YOU ARE NOT USING EPIC 
A COPY MUST BE PLACED IN THE PARTICIPANT’S MEDICAL RECORD (UNLESS NO MEDICAL RECORD EXISTS OR WILL BE CREATED).  
 
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN THE CONSENT OF RESEARCH 
PARTICIPANTS.