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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 overactivity
Renal and Urogenital - Other renal and urogenital disorders
Other - 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
NameTimeMethod
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
NameTimeMethod
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]
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