Clinical Research Directory

Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations

The objective of this study is to test the idea that Pulsed Electromagnetic Field (PEMF) therapy will serve as a safe therapeutic modality that can effectively be administered simultaneously with bladder instillations of a bupivacaine-heparin cocktail to improve the chronic pain and/or associated symptoms of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) patients. The study team will distribute the PEMF device to female adults with IC/BPS who have been prescribed bladder instillations of bupivacaine-heparin to see if PEMF therapy in conjunction with bladder instillations of heparin and bupivacaine may be more effective in reducing pain levels and symptomatology of IC/BPS than instillations alone.

The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner's Lesions

To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis with Hunner's lesions to reduce cicatricial changes in the bladder caused by electrocoagulation and to prevent secondary bladder shrinkage with a decrease in its volume.

EPPIC: Easing Pelvic Pain Interventions Clinical Research Program

The EPPIC (Easing Pelvic Pain Interventions Clinical Research Program) study evaluates an ultra-brief, 4 session cognitive behavioral pain treatment transdiagnostic in design for urologic chronic pain syndrome (UCPPS) with clinical and practical advantages over existing behavioral therapies whose length and focus limits their adoption by clinicians and coverage for mechanistically similar comorbidities. A theoretically informed, practical, empirically grounded approach will systematically unpack CBT's working mechanisms, clarify for whom it works, ease dissemination, appeal to patients, providers, payers, and policy makers in the COVID-19 era favoring low resource intensity treatments, and reduce cost and inefficiencies associated with high intensity therapies whose complexity, length, and scarcity restricts uptake and impact.

Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS

This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, multi-center, single-dose, pharmacodynamic study designed to evaluate the efficacy and safety of the combination product (VNX001) versus placebo and its individual components (heparin sodium and lidocaine hydrochloride (HCl)) for the reduction of bladder pain in patients with interstitial cystitis (IC) / bladder pain syndrome (BPS), Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity.

Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)

This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS). The study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. The main aim of the study is to tally the number of doses and assess pain before and after doses. The study will review the safety and tolerability of VNX001. Participants will need to attend up to seven (7) clinic visits (1 for screening and up to 6 visits for VNX001 dosing) or at least one (1) clinic visit (for a combined screening/dosing visit) and 5 telephone visits over the course of 14 days. Participants will also be asked complete a diary or telephone call each day of the study, in order to record bladder pain, urinary urgency, side effects, and medications taken.

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.

Acupuncture First for IC/BPS

The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is: Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture. Participants will * complete surveys about their bladder pain symptoms * make behavioral changes that have been shown to improve bladder pain symptoms * attend six (6) weekly acupuncture sessions * attend six (6) weekly physical therapy sessions after finishing acupuncture

Identifying Genetic Causes of IC/BPS

Interstitial cystitis (IC), also called Bladder Pain syndrome (BPS) is a common condition with no known cause or cure. Twin studies and family accounts have suggested that the condition may be genetic or passed down (inherited) from one generation to another. In this study, the investigators are collecting genetic material via blood or saliva and medical information from families in North America in an attempt to identify genetic factors that may cause IC/BPS. The investigators are enrolling inviduals with IC/BPS and their family members (family members with and without IC like symptoms). Travel to Boston not required.

Investigation of PEMF Therapy for Female Patients With IC/BPS

The purpose of this study is to gather information about the safety and effectiveness of the non-pharmacological (non-drug), non-invasive treatment known as low-frequency pulsed electromagnetic field (PEMF) therapy. The study team will distribute the PEMF device to female adults with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) to measure its ability to decrease bladder and pelvic pain as well as other urinary symptoms associated with IC/BPS. There are two sequential Aims in this study and subjects will be recruited to participate in only one Aim. In both Aims, data will be collected at baseline/enrollment, 4-weeks after using PEMF therapy, and 8, 12, and 16 weeks post-enrollment.

Migraine Medication Effects on Urinary Symptoms

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis

The purpose of this study is to assess the safety and efficacy of super-concentrated, freeze-dried aloe vera capsules for treatment of interstitial cystitis.

Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of intravesical ozone therapy in 60 patients with interstitial cystitis (IC). Participants were assigned to ozone therapy, placebo, or standard care groups for 3 weeks, with follow-up at 6 weeks. The primary outcome was the change in O'Leary-Sant ICSI score. Secondary outcomes included VAS pain score, SF-36 physical health, and urinary frequency.

Bladder Botox UTI Antibiotic Prophylaxis

Overactive bladder (OAB) is a common condition with a prevalence of 17% in the general population that significantly affects quality of life. Intradetrusor onabotulinumtoxinA injections are an advanced therapy for OAB as well as interstitial cystitis/bladder pain syndrome (IC/BPS). The most common adverse event following intradetrusor injection of onabotulinumtoxinA in urinary tract infection (UTI), which occurs in 8.6-48.1% of patients. To prevent UTIs, patients are given a course of antibiotics, however the ideal prophylactic regimen has not been determined for the timing, duration, and type of antibiotic. Four retrospective studies in the literature address this question with variable conclusions, and there are no prospective studies. Identifying the ideal regimen is important for preventing UTIs as well as minimizing antibiotic use to prevent adverse effects and development of antibiotic resistance. The population to be studied will be female patients 18 years and older who are patients of the urogynecology and urology clinics at Walter Reed National Military Medical Center with a diagnosis of OAB or IC/BPS and have chosen to be treated with intradetrusor onabotulinumtoxinA injections. It will be a non-blinded randomized controlled noninferiority trial in which the patients are randomly placed into 2 groups. The first group will receive a 3 day course of twice daily oral nitrofurantoin 100mg starting at the time of the procedure, and the second group will receive a single dose of 100mg oral nitrofurantoin at the time of the procedure. The patients will be screened at the clinic at the time that they schedule their intradetrusor onabotulinumtoxinA injection appointment or by phone 1-2 weeks prior to their procedure. If the patient agrees to participate in the study then they will be instructed to give a urine sample for urinalysis and culture 1 week prior to the procedure appointment to exclude existing UTI. If a UTI is diagnosed at this time they must complete treatment prior to the procedure or will need to reschedule their procedure. On the day of the procedure patients will receive the clinic standard 10ml of 2% viscous lidocaine through the urethra 10-20 minutes prior to the procedure, and may be offered 5-10mg oral diazepam at the discretion of the treating physician. All patients will be given 200mg of phenazopyridine and 100mg of nitrofurantoin prior to the initiation of the procedure. The procedure will take place as directed by the treating physician per standard operating procedure. A urinalysis and urine culture will be placed for all study participants at time of their procedure appointment in case they have symptoms of UTI, and they will be instructed to follow up with the research team by phone if they have concerns for a UTI. Patients will be contacted 30-45 days after the procedure by phone, email, or message through genesis and asked about any UTI symptoms, UTI diagnoses and secondary outcomes during the 30 days following the procedure. Data will be analyzed for the primary outcome of UTI rates in the 30 days following intradetrusor onabotulinumtoxinA injection.

Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation

This study aims to evaluate a catheter-free method for delivering medications directly into the bladder, known as intravesical instillation, which is commonly used to treat conditions such as interstitial cystitis/bladder pain syndrome (IC/BPS), recurrent urinary tract infections, bladder cancer, and post-chemotherapy or post-radiation cystitis. The study investigates whether this method, which eliminates the need for catheterization, reduces discomfort and complications while maintaining treatment effectiveness. By collecting data on patient experiences and outcomes, the study seeks to determine if this approach provides a safer and more comfortable alternative to traditional catheter-based treatments.

Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome

Interstitial cystitis/bladder pain syndrome (IC/BPS) is estimated to affect 3.3 to 7.9 million women aged 18 years and older in the United States. The American Urological Association (AUA) defines IC/BPS as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes". IC/BPS significantly impacts quality of life, with the individual domains of sexual function, anxiety and depression, sleep quality and work productivity being specifically affected. Significant sexual dysfunction in women with IC/BPS has been consistently demonstrated across multiple international studies, with a prevalence ranging from 68% to 91%. In fact, among all patients with lower urinary tract symptoms, patients with a diagnosis of IC/BPS had the highest levels of impaired sexual function, mostly due to dyspareunia. Recommended treatments for IC/BPS include dietary and behavioral modifications, oral medications, bladder instillations, bladder hydrodistension, intradetrusor injection of onabotulinumtoxinA and major surgery. Scant research exists on how treating IC/BPS affects sexual function. We are conducting a prospective cohort study to assess for improvement in sexual function following intravesical onabotulinumtoxinA injection versus conservative management for IC/BPS. The study will consist of three groups: intradetrusor onabotulinumtoxinA injection, conservative management and age-matched, healthy controls. All patients aged 18 years and older presenting to the Walter Reed National Military Medical Center (WRNMMC) Urogynecology clinic who are given a diagnosis of IC/BPS and have an O'Leary Sant index questionnaire scoring 13 or greater will be eligible for the study. The primary study outcome is change in the pre- and 12-week post-treatment Female Sexual Function Index (FSFI). The secondary outcomes will include changes in the pre- and post-treatment O'Leary Sant index, Patient Global Impression of Improvement (PGI-I), Patient Global Impression of Severity (PGI-S), Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), Visual analog pain scale and 24-hour bladder diary (number of daily voids, number of nightly voids, incontinence episode). Adverse events will be monitored, including urinary tract infection or need for urinary catheterization due to urinary retention within 12 weeks of start of treatment. The age-matched, healthy control group will complete only one set of questionnaires to serve as a baseline comparison to the IC/BPS groups. For between-groups comparisons, a sample size of 49 per group will have 80% power to detect a clinically important difference of 4 points if the standard deviation is 7 points, assuming a 5% two-sided significance level. We will therefore recruit 55 subjects per group to allow for approximately 10% attrition between the pre- and post-treatment assessments. This study will be powered to detect a difference between treatments groups, which has not yet been reported in the literature.

EA for BPS: An RCT and Study for Central Mechanism

This is a randomized controlled and assessor-blinded design trial to evaluate the efficacy and safety of acupuncture for bladder pain syndrome(BPS). All eligible participants will be randomly assigned to the medication group(n=21), EA group(n=42) and SA group(n=21) in a 1:2:1 allocation ratio. Participants will receive 4-week treatments phase followed by a 4-week follow-up phase. Outcomes will be assessed at baseline, during the treatment and at the end of the follow-up. Outcome assessors, data managers and statisticians will be blinded to the group allocation, while acupuncturists and participants will not be blinded for obvious reasons. Besides, fMRI will be used to collect spontaneous electrical activity of the brain of patients. In this trial, the investigators assume that electroacupuncture for BPS, compared to amitriptyline, is instrumental in improving symptoms such as pain, frequent micturition and emotional disorder.

Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a common, chronic, and debilitating condition in women. Preliminary evidence suggests that IC/BPS pain can be reduced applying non-invasive repetitive transcranial magnetic stimulation (rTMS) to areas of the brain that regulate pelvic floor muscle activity. However, prior studies have examined rTMS in a very limited sample and have not examined changes in brain or pelvic floor muscle activity to determine the mechanism of rTMS for IC/BPS. This study is designed to directly address these limitations.

New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome

Many women suffer from bladder pain syndrome (BPS). There are many treatments, but there is no one universally effective option. The goal of this clinical trial is to explore the use of electrical energy directed towards a group of nerves, called the superior hypogastric plexus, for treatment of BPS in women over the age of 18 with a diagnosis of BPS. The main question it aims to answer is: does use of electrical micro-current directed at the superior hypogastric plexus improve pain associated with BPS over the use of placebo? There is data from many different studies that suggest that this kind of therapy might provide relief of BPS symptoms. Participants will be asked to participate for a total of six months from the date of their first nerve treatment. At the first appointment, they will be evaluated in the Walter Reed Chronic Pain clinic and asked several questions about the severity and personal management of their symptoms. The procedure will then be performed by inserting two needles into the back (one on either side of the spine) and directing extremely short bursts of electrical micro-current towards the target nerve. The medical term for this is "pulsed radiofrequency ablation." This procedure causes disruption on a microscopic level of nerve fibers that send pain sensations to the bladder and other organs in the pelvis. Some participants will receive treatment, whereas others will receive sham (placebo). Participants will not be informed of their treatment group until the conclusion of the study. Following this initial appointment, participants will be asked about their symptoms at 1-, 3-, and 6-month follow-up appointments. Participants will be asked about pain, mood symptoms, sexual function, and measures of bladder irritation. The procedure will only be performed once. At the study conclusion, researchers will compare treatment and sham groups to see if pain scores, as well as other secondary outcomes listed above, are different between these groups. Benefits of this study may include possible relief of BPS symptoms. This may help to advance research about treatments for BPS. This is a novel approach to the treatment of BPS and as such may provide benefits greater than those found in treatment outside of the study.

Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome

Interstitial cystitis / bladder pain syndrome (IC/BPS) is a debilitating condition that affects millions of women in the United States. Women suffer from recurring pelvic pain, bladder pressure, painful bladder, urinary frequency (needing to go often) and urgency (feeling a strong need to go). Women are five times more likely to suffer from IC/BPS than men. IC/BPS is a common cause of painful bladder after excluding urinary tract infection. About one-third of women resort to opioids, thus contributing to the current opioid crisis. Sadly, there are no durable treatments and the majority of therapies are not FDA-approved for IC/BPS.

fMRI for BPS: A Descriptive Study of Findings and Symptoms

The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are: 1. To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population. 2. To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS. Participants will undergo fMRI as well as other routine laboratory tests and queries.