The effects of botulinum toxin A on patients with idiopathic detrusor overactivity. A double-blind, randomised, placebo-controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16995641

Enrollment

Registered

2005-10-19

Start date

2004-05-01

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

Overactive bladder symptoms and idiopathic detrusor overactivity. Urological and Genital Diseases Other disorders of bladder

Interventions

Baseline: voiding diary, urodynamics, quality of life (QoL) questionnaires. Flexible cystoscopy and 3 bladder biopsies followed by injection of either 200 u of botulinum toxin A (20 injections at 10 u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Refractory to traditional anticholinergic therapy either due to poor efficacy or side effects 2. Proven detrusor overactivity on urodynamic studies 3. Detrusor overactivity of non-neurogenic origin

Exclusion criteria

Exclusion criteria: 1. Pregnancy or planned pregnancy 2. Breast Feeding 3. Indwelling catheter 4. Current anticoagulation e.g. heparin or warfarin 5. Neurogenic detrusor overactivity 6. Painful bladder syndromes 7. Previous bladder surgery e.g. augmentation cystoplasty

Design outcomes

Primary

Measure	Time frame
1. Urinary frequency/24 hours 2. Maximum cystometric capacity	—

Secondary

Measure	Time frame
1. Urinary urgency/24 hours 2. Urge incontinence/24 hours 3. QoL: 3 validated QoL questionnaires (KHQ, UDI6, IIQ7) 4. Urodynamic variables: 4.1. time to first invluntary detrusor contraction 4.2. maximum detrusor pressure on filling/voiding 4.3. post void residual	—

Countries

United Kingdom

Outcome results

None listed

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