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

Overactive Bladder Clinical Trial

Official title:

Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder (OAB). A Multicenter Phase II, Randomized, Double-blind, Placebo Controlled 6 Month Study . VESITOX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231491
• Other study ID #: P030438
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2005
• Last updated: February 16, 2011
• Start date: November 2005
• Est. completion date: April 2010

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Botulinum Toxin A (Botox )

Locations

Country	Name	City	State
France	RAYMOND POINCARE Hospital	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Rajkumar GN, Small DR, Mustafa AW, Conn G. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int. 2005 Oct;96(6):848-52. — View Citation

Outcome

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