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)

Phase 2

Completed

Conditions: Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Interventions: Drug: BOTOX
Drug: Placebo for BOTOX

Registration Number: NCT05141006

Lead Sponsor: AbbVie

Brief Summary: 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 1 in 2 chance that participants will be assigned to placebo. Approximately 80 female participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in approximately 40 sites in the United States and Canada.

Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be followed for at least 12 weeks in treatment 1. Eligible participants may request additional dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period 2.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 83

Inclusion Criteria

Presence of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms for at least 6 months, diagnosed by the investigator as IC/BPS, and confirmed dominant bladder derived pain.

Exclusion Criteria

History or current diagnosis of Hunner Lesions.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	BOTOX	Participants will receive placebo on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24.
Placebo	Placebo for BOTOX	Participants will receive placebo on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24.
BOTOX	BOTOX	Participants will receive BOTOX on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24.

Primary Outcome Measures

Name	Time	Method
Change in Average Daily Worst Bladder Pain	Baseline (Week 0) to Week 6	Daily worst bladder pain will be assessed on the 11-point (0-10) numeric rating scale where 0 = no pain and 10 = the worst pain possible.

Secondary Outcome Measures

Name	Time	Method
Change in the Average Number of Urgency Episodes per 24-hour Period	Baseline (Week 0) to Week 6	Urgency episodes will be reported in the 3-day bladder diary.
Change in the Average Number of Nocturia Episodes per 24-hour Period	Baseline (Week 0) to Week 6	Nocturia episodes will be reported in the 3-day bladder diary.
Change in the Average Number of Micturition Episodes per 24-hour Period	Baseline (Week 0) to Week 6	Micturition (whether participant was able to urinate) episodes will be collected on the 3-day bladder diary.

Trial Locations

Locations (43): Urology Centers of Alabama /ID# 243600
🇺🇸
Homewood, Alabama, United States
Urology Associates of Mobile, PA /ID# 255854
🇺🇸
Mobile, Alabama, United States
Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002
🇺🇸
Mobile, Alabama, United States
Sun Kim Urology /ID# 257566
🇺🇸
Buena Park, California, United States
Cedars-Sinai Medical Center /ID# 245786
🇺🇸
Los Angeles, California, United States
University of California, Los Angeles /ID# 245131
🇺🇸
Los Angeles, California, United States
Tri Valley Urology Medical Group /ID# 254918
🇺🇸
Murrieta, California, United States
Inland Urology /ID# 255410
🇺🇸
Pomona, California, United States
UCSD Medical Center /ID# 244935
🇺🇸
San Diego, California, United States
Prestige Medical Group /ID# 257564
🇺🇸
Santa Ana, California, United States
Scroll for more (33 remaining)
Urology Centers of Alabama /ID# 243600
🇺🇸Homewood, Alabama, United States