Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.

Phase 2

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT00231491
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

Detailed Description

This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

Study Timeline

• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-04
• Study Start: 2005-11
• Status Verified: 2007-03
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Overactive bladder with more than 3 episodes of urgency of urge incontinence per day

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of urgency and urge incontinence episodes at 3 months after injection	at 3 months

Secondary Outcome Measures

Name	Time	Method
Number of micturition episodes on micturition chart per day	per day
Mean value of volume of urine per micturition
Mean delay between urgency and leakage Quality of life improvement by Iqol and EuroQol (EQ-5D)
Urodynamic parameters : Volume at first contraction, volume at first desire to void, volume at urgency, maximal bladder capacity, maximal detrusor pressure
Number of pads used per day
Number of patients with less than 3 episodes per day of leakages by urge incontinence or urgency per day
Residual volume of urine after flowmetry
Maximal flow
Visual analogic scale for pain for procedure
Biologic modifications
Ultrasound of kidneys
Toxin A antibodies

Trial Locations

Locations (1)

RAYMOND POINCARE Hospital; 🇫🇷 Garches, France