NCT00308009

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

April 28, 2015

Status Verified

November 1, 2007

Enrollment Period

5.6 years

First QC Date

March 27, 2006

Last Update Submit

April 27, 2015

Conditions

Pelvic Organ ProlapseUrinary Stress Incontinence

Keywords

Pelvic Organ ProlapseUrinary stress incontinenceSurgery

Outcome Measures

Primary Outcomes (1)

  • Any or no leakage of urine when coughing

    1 year

Secondary Outcomes (2)

  • The cure of urinary stress incontinence (USI) by only prolapse surgery

    1 year

  • Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Group I, Prolapse repair and TVT concomitantly

Procedure: Vaginal Repair for prolapse, TVT procedureProcedure: TVT and Prolapse surgery

2

ACTIVE COMPARATOR

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

Procedure: Vaginal Repair for prolapse, TVT procedureProcedure: TVT and Prolapse surgery

Interventions

Vaginal Repair for prolapse, TVT procedurePROCEDURE

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

Also known as: Incontinence surgery, Mid-urethra sling, Prolapse surgery., Prolapse repair
12
TVT and Prolapse surgeryPROCEDURE

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

12

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary Incontinence, Stress

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Study Officials

  • Ellen Borstad, MD

    Michael Abdelnoor Phd, Department of epidemiology (same hospital)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 28, 2006

Study Start

February 1, 2002

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

April 28, 2015

Record last verified: 2007-11