Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000598886
Ethics application status
Approved
Date submitted
1/06/2012
Date registered
4/06/2012
Date last updated
4/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of the drug resiniferatoxin on the bladder as a treatment for cases of incontinence previously unresponsive to treatment.
Scientific title
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.
Secondary ID [1] 280572 0
Therapeutic Goods Administration CTN: 2004/236
Secondary ID [2] 280608 0
Therapeutic Goods Administration: Protocol Number: RTX01
Universal Trial Number (UTN)
U1111-1131-3439
Trial acronym
RTX for Refractory IDO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory idiopathic detrusor overactivity 286574 0
Condition category
Condition code
Renal and Urogenital 286850 286850 0 0
Other renal and urogenital disorders
Other 286895 286895 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 284959 0
Treatment: Drugs
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287203 0
Frequency volume chart (Voids per day/night)
Timepoint [1] 287203 0
Prior to commencement, 1 month and 3 months after resiniferatoxin treatment
Primary outcome [2] 287204 0
International Consultation on Incontinence Questionnaire (ICIQ)
Timepoint [2] 287204 0
Prior to commencement, 1 month and 3 months after resiniferatoxin treatment
Primary outcome [3] 287205 0
Urogenital Distress Inventory (UDI)
Timepoint [3] 287205 0
Prior to commencement, 1 month and 3 months after treatment with resiniferatoxin
Secondary outcome [1] 297629 0
24 hour Pad testing (grams of leakage per 24 hours)
Timepoint [1] 297629 0
Prior to commencement, 1 month and 3 months after resiniferatoxin treatment
Secondary outcome [2] 297631 0
Incontinence Impact Questionnaire (IIQ)
Timepoint [2] 297631 0
Prior to commencement, 1 month and 3 months after resiniferatoxin treatment

Eligibility
Key inclusion criteria
Urodynamically proven idiopathic detrusor overactivity refractory to at least two anticholinergic treatments for 12 months
Minimum age
25 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pure stress incontinence, current bacterial cystitis, neurological disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285344 0
Hospital
Name [1] 285344 0
Pelvic Floor Unit Research Fund (St George Hospital)
Country [1] 285344 0
Australia
Primary sponsor type
Hospital
Name
Pelvic Floor Unit Research Fund (St George Hospital)
Address
St George Hospital
Department of Urogynaecology
Gray St
Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 284195 0
None
Name [1] 284195 0
Address [1] 284195 0
Country [1] 284195 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287346 0
SESIAHS Human Research Ethics Committee
Ethics committee address [1] 287346 0
Research Management Office
St George Hospital
3rd Floor James laws House
Gray Street, Kogarah
NSW 2217
Ethics committee country [1] 287346 0
Australia
Date submitted for ethics approval [1] 287346 0
Approval date [1] 287346 0
20/04/2004
Ethics approval number [1] 287346 0
04/43 Moore

Summary
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
Trial website
Trial related presentations / publications
Moore KH, Allen W, Leek H, Bushati T, Woodman J, Burcher E. Response to resiniferatoxin disappointing in idiopathic detrusor overactivity. Proc. 3rd Annual Meeting on Advances in Urogenital Research. 2006; 8-9
Public notes

Contacts
Principal investigator
Name 34237 0
Address 34237 0
Country 34237 0
Phone 34237 0
Fax 34237 0
Email 34237 0
Contact person for public queries
Name 17484 0
Professor Kate H Moore
Address 17484 0
St George Hospital
Pitney Clinical Sciences Building
Short St, Kogarah
NSW 2217
Country 17484 0
Australia
Phone 17484 0
+61 2 9113 2054
Fax 17484 0
Email 17484 0
k.moore@unsw.edu.au
Contact person for scientific queries
Name 8412 0
Professor Kate H Moore
Address 8412 0
St George Hospital
Pitney Clinical Sciences Building
Short St, Kogarah
NSW 2217
Country 8412 0
Australia
Phone 8412 0
+61 2 9113 2054
Fax 8412 0
Email 8412 0
k.moore@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Documents added automatically
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