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Completed

NCT Number: NCT00231491

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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RAYMOND POINCARE Hospital

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Botulinum Toxin A (Botox )

Drug

Primary outcomes

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

    Time frame: at 3 months

Secondary outcomes

  1. Number of micturition episodes on micturition chart per day

    Time frame: per day

  2. Mean value of volume of urine per micturition

  3. Mean delay between urgency and leakage Quality of life improvement by Iqol and EuroQol (EQ-5D)

  4. Urodynamic parameters : Volume at first contraction, volume at first desire to void, volume at urgency, maximal bladder capacity, maximal detrusor pressure

  5. Number of pads used per day

  6. Number of patients with less than 3 episodes per day of leakages by urge incontinence or urgency per day

  7. Residual volume of urine after flowmetry

  8. Maximal flow

  9. Visual analogic scale for pain for procedure

  10. Biologic modifications

  11. Ultrasound of kidneys

  12. Toxin A antibodies

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Oct 4, 2005
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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