Botulinum toxin-A in sensory urgency

Completed

• Conditions: Sensory urgency, overactive bladder; Urological and Genital Diseases

• Registration Number: ISRCTN57577615
• Lead Sponsor: Guy's and St Thomas' NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Informed consent to participate
2. Male and females 18 to 80 years of age
3. Symptoms of overactive bladder
4. Refractory to anticholinergics
5. No evidence of detrusor overactivity on urodynamic studies

Exclusion Criteria

1. Pregnancy or planned pregnancy in the next year
2. Breast feeding
3. Painful bladder syndrome or interstitial cystitis
4. Evidence of significant outflow obstruction
5. Indwelling catheter
6. Previous bladder surgery e.g. augmentation cystoplasty
7. Previous urological use of botulinum toxin
8. Other bladder pathology e.g. tumours, active infection
9. Proven detrusor overactivity
10. Current anticoagulation treatment e.g. heparin, warfarin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rodynamics: Maximum cystometric capacity

Secondary Outcome Measures

Name	Time	Method
1. Three day bladder voiding diaries to assess urinary frequency, urgency and incontinence episodes<br>2. Validated quality of life questionnaires:<br>a. King?s Health Questionnaire (KHQ)<br>b. Incontinence Impact Questionnaire short form (IIQ-7)<br>c. Urogenital Distress Inventory short form (UDI-6)