NCT06729151 Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome
| NCT ID | NCT06729151 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Walter Reed National Military Medical Center |
| Condition | Bladder Pain Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 159 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 159 participants in total. It began in 2024-11-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Female 18 years of age and older * For bladder pain syndrome participants: O'Leary Sant score 13 or greater * For healthy controls: O'Leary Sant score 12 or less * DEERS eligible (care provided by military health care system) Exclusion Criteria: * Contraindications for bladder Botox * Current use of alternative treatment for bladder pain syndrome * Neurogenic bladder * Other urinary tract disease * Pelvic organ prolapse stage 3 or greater * Pregnancy or breastfeeding * Non-English speakers
Frequently Asked Questions
Who can join the NCT06729151 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Bladder Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06729151 currently recruiting?
Yes, NCT06729151 is actively recruiting participants. Visit ClinicalTrials.gov or contact Walter Reed National Military Medical Center to inquire about joining.
Where is the NCT06729151 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06729151 clinical trial?
NCT06729151 is sponsored by Walter Reed National Military Medical Center. The trial plans to enroll 159 participants.