ActivePhase 4ACTRN12612000598886

The effect of the drug resiniferatoxin on the bladder as a treatment for cases of incontinence previously unresponsive to treatment.

25-90 year old females with urodynamically proven refractory idiopathic detrusor activity given resiniferatoxin to assess the benefits of resiniferatoxin treatment on frequency volume chart, quality of life, leakage pad tests.


Sponsor

Pelvic Floor Unit Research Fund (St George Hospital)

Enrollment

50 participants

Start Date

May 30, 2004

Study Type

Interventional

Conditions

Summary

This project involves administering a solution into the bladder to treat incontinence, which ahs already been used in eight countries overseas. Urge incontinence (detrusor overactivity (DO)) is treated with anticholinergic drugs which are generally palliative, not curative. Bladder instillation of vanilloids i.e. capsaicin and resiniferatoxin (RTX) for DO has shown symptomatic improvement for up to 3 months. We wish to offer this therapy for urge incontinent women who have not responded to two anticholinergic drugs. RTX will be instilled into the bladder via a urinary catheter. Women will be assessed at 1 and 3 months by routine measures. This novel project will study which types of DO respond best to the treatment


Eligibility

Sex: FemalesMin Age: 25 YearssMax Age: 90 Yearss

Inclusion Criteria1

  • Urodynamically proven idiopathic detrusor overactivity refractory to at least two anticholinergic treatments for 12 months

Exclusion Criteria1

  • Pure stress incontinence, current bacterial cystitis, neurological disease

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Interventions

10 mL of 500nM (50nM) resiniferatoxin stock was diluted with 90mL of sterile saline and stored in dark,sterile conditions at 20 degrees C (Final concentration: 0.00314mg/100mL). This was instilled in

10 mL of 500nM (50nM) resiniferatoxin stock was diluted with 90mL of sterile saline and stored in dark,sterile conditions at 20 degrees C (Final concentration: 0.00314mg/100mL). This was instilled in the bladder for 30 minutes and drained via a urinary catheter. This intervention was administered to each participant on one occasion only


Locations(1)

Australia

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ACTRN12612000598886