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NCT00308009 Clinical Trial

Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After

Pelvic Organ Prolapse Clinical Trial

Official title:
Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00308009
Other study ID # TVT Prolapse study
Secondary ID
Status Completed
Phase N/A
First received March 27, 2006
Last updated April 27, 2015
Start date February 2002
Est. completion date September 2007

Study information
Verified date November 2007
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

Description:

All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.

Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.

Recruitment information / eligibility
Status Completed
Enrollment 194
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -

Exclusion Criteria: Not agreed to participate in randomization

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Vaginal Repair for prolapse, TVT procedure
TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair
• TVT and Prolapse surgery
TVT at the time of Prolapse surgery TVT 3 months after Prolapse Surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ullevaal University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Any or no leakage of urine when coughing 1 year Yes
Secondary The cure of urinary stress incontinence (USI) by only prolapse surgery 1 year No
Secondary Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI 1 year Yes
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