Botulinum toxin-A in sensory urgency

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57577615

Enrollment

Registered

2006-09-21

Start date

2006-10-01

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

Sensory urgency, overactive bladder Urological and Genital Diseases Sensory urgency, overactive bladder

Interventions

Intervention group: Botulinum toxin-A will be administered at 100-150 units. Control group: Placebo (normal saline solution) will be administered in the same way as the intervention group.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Urodynamics: Maximum cystometric capacity	—

Secondary

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

Countries

United Kingdom

Outcome results

None listed

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