Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000182695
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
19/08/2005
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using the Gynecare MoniTorr* device to measure urethral pressure before incontinence surgery
Scientific title
The measurement of urethral pressure with the MoniTORR* device to predict outcome after urinary incontinence surgery based on urodynamics studies at 6 months.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urethral pressure 278 0
Condition category
Condition code
Renal and Urogenital 314 314 0 0
Other renal and urogenital disorders
Surgery 315 315 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Urethral retro-resistance pressure (URP)measurement.
Intervention code [1] 146 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 368 0
Urodynamic stress incontinence
Timepoint [1] 368 0
At 6 months after surgery
Secondary outcome [1] 824 0
Visual analogue scale of patient satisfaction
Timepoint [1] 824 0
Secondary outcome [2] 825 0
Bladder diary
Timepoint [2] 825 0

Eligibility
Key inclusion criteria
Women with urodynamics stress incontinence undergoing a TVT procedure at the two study centres. Concomitant prolapse surgery is not a contraindication. Willingness to participate.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medically unfit for surgery. Refusal to participate. Patients who are recommended surgery other than TVT (e.g. Colposuspension, Sling, Bulking agent, Transobturator procedure).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 371 0
Commercial sector/Industry
Name [1] 371 0
Johnson & Johnson Medical
Country [1] 371 0
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Medical
Address
Country
United States of America
Secondary sponsor category [1] 294 0
None
Name [1] 294 0
n/a
Address [1] 294 0
Country [1] 294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1361 0
Royal Women's Hospital Human Ethics Committee
Ethics committee address [1] 1361 0
Ethics committee country [1] 1361 0
Australia
Date submitted for ethics approval [1] 1361 0
Approval date [1] 1361 0
Ethics approval number [1] 1361 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35779 0
Address 35779 0
Country 35779 0
Phone 35779 0
Fax 35779 0
Email 35779 0
Contact person for public queries
Name 9335 0
Dr Marcus Carey
Address 9335 0
Frances Perry House
Suite D Level 10
Cardigan St
Carlton VIC 3053
Country 9335 0
Australia
Phone 9335 0
+61 3 92215099
Fax 9335 0
+61 3 92215299
Email 9335 0
mcarey@affinityhealth.com.au
Contact person for scientific queries
Name 263 0
Dr Peta Higgs
Address 263 0
Urogynaecology Department
Royal Women's Hospital
Grattan St
Carlton VIC 3053
Country 263 0
Australia
Phone 263 0
+61 3 93442000
Fax 263 0
Email 263 0
peta_higgs@hotmail.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.