The effect of the drug resiniferatoxin on the bladder as a treatment for cases of incontinence previously unresponsive to treatment.
Phase 4
Active, not recruiting
- Conditions
- Refractory idiopathic detrusor overactivityRenal and Urogenital - Other renal and urogenital disordersOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12612000598886
- Lead Sponsor
- Pelvic Floor Unit Research Fund (St George Hospital)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Urodynamically proven idiopathic detrusor overactivity refractory to at least two anticholinergic treatments for 12 months
Exclusion Criteria
Pure stress incontinence, current bacterial cystitis, neurological disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency volume chart (Voids per day/night)[Prior to commencement, 1 month and 3 months after resiniferatoxin treatment];International Consultation on Incontinence Questionnaire (ICIQ)[Prior to commencement, 1 month and 3 months after resiniferatoxin treatment];Urogenital Distress Inventory (UDI)[Prior to commencement, 1 month and 3 months after treatment with resiniferatoxin]
- Secondary Outcome Measures
Name Time Method 24 hour Pad testing (grams of leakage per 24 hours)[Prior to commencement, 1 month and 3 months after resiniferatoxin treatment];Incontinence Impact Questionnaire (IIQ)[Prior to commencement, 1 month and 3 months after resiniferatoxin treatment]