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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000598886

Acronym

RTX for Refractory IDO

Enrollment

Registered

2012-06-04

Start date

2004-05-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 the bladder for 30 minutes and drained via a urinary catheter. This intervention was administered to each participant on one occasion only

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

25 Years to 90 Years

Healthy volunteers

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

Outcome results