Trigonal versus trigone-sparing intradetrusor injection of Botulinum Toxin-A for idiopathic detrusor overactivity

Completed

• Conditions: Idiopathic detrusor overactivity; Urological and Genital Diseases; Other disorders of urinary system

• Registration Number: ISRCTN12589059
• Lead Sponsor: Adelaide and Meath Hospital (Ireland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Male and female patients, 17 years and over
2. Urodynamic-confirmed detrusor overactivity
3. Have failed greater than or equal to 6 weeks anticholinergic therapy or discontinued therapy due to intolerability

Exclusion Criteria

1. Patients with any neurological condition or coagulopathies
2. Men with clinical or urodynamic evidence of bladder outflow obstruction
3. Patients with active urinary tract infection
4. Women with positive pregnancy test

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overactive Bladder Symptom Score (OABSS) Questionnaire Total Score at baseline and at 6 weeks after injection (score range 7-28)

Secondary Outcome Measures

Name	Time	Method
1. OABSS Questionnaire Total Score are 12 and 26 weeks (score range 7-28)<br>2. OABSS urgency subscale score at 6, 12 and 26 weeks (score range 4-16)<br>3. Urodynamic parameters at baseline and at 6 weeks<br>4. Specifically maximum detrusor pressure<br>5. Maximum cystometric capacity<br>6. Volume at first desire to void<br>7. Volume at urgent desire to void<br>8. Post void residual volume <br>9. Time to symptom recurrence