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

NCT ID: NCT00308009

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2007-09-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse Urinary Stress Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group I, Prolapse repair and TVT concomitantly

Group Type ACTIVE_COMPARATOR

Vaginal Repair for prolapse, TVT procedure

Intervention Type PROCEDURE

1. TVT at the time of Vaginal Repair
2. TVT 3 months after Vaginal Repair

TVT and Prolapse surgery

Intervention Type PROCEDURE

1. TVT at the time of Prolapse surgery
2. TVT 3 months after Prolapse Surgery

2

Group II, Prolapse repair and TVT 3 months afterwards if necessary

Group Type ACTIVE_COMPARATOR

Vaginal Repair for prolapse, TVT procedure

Intervention Type PROCEDURE

1. TVT at the time of Vaginal Repair
2. TVT 3 months after Vaginal Repair

TVT and Prolapse surgery

Intervention Type PROCEDURE

1. TVT at the time of Prolapse surgery
2. TVT 3 months after Prolapse Surgery

Interventions

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Vaginal Repair for prolapse, TVT procedure

1. TVT at the time of Vaginal Repair
2. TVT 3 months after Vaginal Repair

Intervention Type PROCEDURE

TVT and Prolapse surgery

1. TVT at the time of Prolapse surgery
2. TVT 3 months after Prolapse Surgery

Intervention Type PROCEDURE

Other Intervention Names

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Incontinence surgery Mid-urethra sling Prolapse surgery. Prolapse repair

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ullevaal University Hospital

Principal Investigators

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Ellen Borstad, MD

Role: PRINCIPAL_INVESTIGATOR

Michael Abdelnoor Phd, Department of epidemiology (same hospital)

Other Identifiers

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TVT Prolapse study

Identifier Type: -

Identifier Source: org_study_id

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