Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder. - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00231491

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder (OAB)	Drug: Botulinum Toxin A (Botox )	Phase II

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Clostridium botulinum toxin Botulinum toxin A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Number of micturition episodes on micturition chart 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

Estimated Enrollment:	160
Study Start Date:	November 2005
Estimated Study Completion Date:	April 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231491

Contacts

Contact: Pierre DENYS, MD

+33(0)-1 47 10 70 72

pierre.denys@rpc.aphp.fr

Locations

France
RAYMOND POINCARE Hospital	Recruiting
GARCHES, France, 92380
Contact: Philippe DENYS, MD +33(0)-1 47 10 70 72 pierre.denys@rpc.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Pierre DENYS, MD

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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.

Study ID Numbers:	P030438, AOM03111
Study First Received:	October 3, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00231491
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Overactive bladder
Urgency
Urge incontinence
Botulinum toxin A
Quality of life

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Botulinum Toxins
Cystocele
Urologic Diseases

Urinary Bladder Diseases
Quality of Life
Urinary Incontinence
Botulinum Toxin Type A
Urinary Incontinence, Urge

Additional relevant MeSH terms:

Urological Manifestations
Anti-Dyskinesia Agents
Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009