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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: Botulinum Toxin A (Botox )

Study type: Interventional

Funder types: Other

Identifiers

NCT00231491

P030438

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind