Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder

Phase 2TerminatedNCT00578097

Ipsen81 enrolled

Overview

The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Overactive Bladder

Interventions

Botulinum toxin type ABIOLOGICAL

Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.

PlaceboDRUG

Single injection cycle, intradetrusor injection at baseline (visit 2).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subject has a diagnosis of idiopathic overactive bladder, without incontinence. * The subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit. * The subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit. Exclusion Criteria: * Bladder outlet obstruction (on urodynamic assessment). * Post-Micturition Residual Volume \> 150 ml (ultrasound assessment). * Evidence of a urinary tract infection at Screening or Baseline in the study. * Active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.

Locations (34)

Outcomes

Primary Outcomes

Number of episodes of urgency and frequency of micturition.

Time frame: Week 12

Secondary Outcomes

The number of episodes of urgency, frequency of micturition, and frequency of nocturia.

Time frame: All timepoints

Severity of urgency.

Time frame: All timepoints

Maximum flow rate and post-micturition residual volume (PMRV).

Time frame: Day 4 and Week 6

Standard International Continence Society (ICS) urodynamic parameters.

Time frame: Week 12

Quality of Life (QoL).

Time frame: All timepoints

Safety

Time frame: All timepoints

Extension study - Duration of effect as determined by the persistence of a positive response.

Time frame: All timepoints

Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.

Time frame: All timepoints

Extension study - Severity of urgency.

Time frame: All timepoints

Extension study Quality of Life (QoL)

Time frame: All timepoints

Extension study safety.

Data from ClinicalTrials.gov

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