Clinical trial

BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age

NCT02097121

Name

191622-137

Description

This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.

Trial arms

Trial start

2014-05-23

Estimated PCD

2022-02-10

Trial end

2022-02-10

Status

Terminated

Phase

Early phase I

Treatment

BOTOX®

Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.

Arms:

Botox 100 U, Botox 25 U, Botox 50 U

Other names:

Botulinum Toxin Type A

Size

Primary endpoint

Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1

From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1

Eligibility criteria

Inclusion Criteria: * Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months * OAB symptoms not adequately managed by 1 or more anticholinergic agents Exclusion Criteria * OAB caused by a neurological condition * Use of anticholinergics or other medications to treat OAB symptoms within 7 days * Current use of indwelling catheter or clean intermittent catheterization to empty the bladder * Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use * Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ACTUAL'}}

Updated at

2022-12-28

1 organization

1 product

3 indications

Product

Indication

Indication

Indication

Organization