Study of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Completed · Phase 2 · NCT05141006
Conditions: Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
At a glance
- Research payments reported, 2025
- $54,472
- U.S. investigators named
- 12
- Sites paid
- 11
- Planned or actual enrollment
- 83
About the trial
- Sponsor
- AbbVie
- Tested
- BOTOX (drug), Placebo for BOTOX (drug)
- Dates
- Started 2022-03-29; completion 2024-12-06
- Results posted
- Not yet
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse events and change in disease symptoms will be evaluated. BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a …
From ClinicalTrials.gov, last updated 2025-05-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $54,472 in research payments for this study in 2025 (17 payments).
Products named: Botox
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Karyn S. Eilber, MD Urology · Beverly Hills, CA
- Lamia Gabal, MD Urology · Santa Ana, CA
- Alan Fine, MD OB-GYN (Obstetrics & Gynecology) · Hartford, CT
- Sean A. Castellucci, D.O. Urology · Bradenton, FL
- Steven C. Kester, MD Urology · Pompano Beach, FL
- Robert J. Evans III, MD Urology · Winston Salem, NC
- Benjamin M. Brucker, MD Urology · New York, NY
- Doreen E. Chung, MD Urogynecology · New Hyde Park, NY
- Helai Hesham, MD Urogynecology · New York, NY
- Steven J. Rowe, M.D. Urology · Middletown, NY
- Vincent R. Lucente, M.D. Urogynecology · Allentown, PA
- Daniel S. Harnsberger, M.D. OB-GYN (Obstetrics & Gynecology) · Chattanooga, TN
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Clinical Research Center of Florida $17,501
- Manatee Medical Research $11,485
- Regional Womens Health Group LLC $5,746
- Columbia University Medical Center $4,829
- The Trustees of Columbia University $3,281
- Wake Forest University $2,820
- Cedars-Sinai Medical Center, CA $2,301
- Chattanooga Medical Research LLC $1,890
- New York University $1,620
- Empirican Prn Inc $1,500
- Folio Clinical Research $1,500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.