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Neurotoxin

BOTOX Injections for Bladder Pain Syndrome

Verified Trial

Phase 2

Recruiting

Research Sponsored by Allergan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you been experiencing symptoms of Interstitial Cystitis/Bladder Pain Syndrome (bladder pain) for at least 6 months?

Have you been diagnosed by a healthcare professional as having IC/BPS?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0) to week 6

Summary

This trial will assess how safe and effective BOTOX is in treating IC/BPS.

Who is the study for?

This trial is for adult women aged 18-75 with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) who've had symptoms for at least 6 months. It's not open to those with a history or current diagnosis of Hunner Lesions.

What is being tested?

The study tests the safety and effectiveness of BOTOX injections versus placebo in treating IC/BPS. Participants are randomly assigned to receive either BOTOX or a placebo, with a follow-up period of up to 24 weeks.

What are the potential side effects?

Possible side effects from BOTOX may include pain at the injection site, urinary tract infections, difficulty urinating, and allergic reactions. The full range of side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had bladder pain for at least 6 months.

Select...

I have been diagnosed with interstitial cystitis/bladder pain syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0) to week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0) to week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) to week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Average Daily Worst Bladder Pain

Secondary study objectives

Change in the Average Number of Micturition Episodes per 24-hour Period

Change in the Average Number of Nocturia Episodes per 24-hour Period

Change in the Average Number of Urgency Episodes per 24-hour Period

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BOTOXExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BOTOX

2013

Completed Phase 4

~1410

0 / 2Eligibility criteria met