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

Prospective randomised controlled trial comparing trigonal versus trigone-sparing intradetrusor injection of botulinum toxin-a for refractory idiopathic detrusor overactivity

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12589059

Enrollment

Registered

2010-10-04

Start date

2010-09-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic detrusor overactivity Urological and Genital Diseases Other disorders of urinary system

Interventions

Patients will be randomised to receive intradetrusor injections of 500u Botulinum Toxin-A (Dysport) sparing the trigone or including the trigone. 500u Dysport will be reconstituted with 20ml 0.9% sali

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026