Back to resultsA 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Surgical treatment: TVT
Surgical treatment: colposuspension
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring stress urinary incontinence, female incontinence, surgical treatment, Female stress urinary incontinence
Eligibility Criteria
Inclusion Criteria:
- Women between the ages of 35 and 70 who had completed their family with a clinical (Booney test positive) and urodynamic diagnosis of Stress Urinary Incontinence
- Previous surgery for prolapse, incontinence or bladder disease, urodynamic diagnosis of detrusor overactivity, or voiding difficulty (defined as maximum flow less than 15 ml/second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 ml)
- Cystocele over grade I
- Previous hysterectomy
- Body mass index (BMI) of 40 or more
- Uncontrolled diabetes
- Neurological disease
- Recurrent urinary tract infections
- Genital atrophy precluding vaginal surgery
- Known bleeding diathesis or current anticoagulant therapy
Sites / Locations
- Hospital Severo Ochoa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tvt group
Burch group
Arm Description
Surgical treatment for incontinence: TVT
Surgical treatment for incontinence: Colposuspension
Outcomes
Primary Outcome Measures
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)
Secondary Outcome Measures
Criteria were established to include patients in one of three groups: cure, improved and treatment failure
Full Information
NCT ID
NCT00782990
First Posted
October 30, 2008
Last Updated
November 4, 2008
Sponsor
Hospital Severo Ochoa
1. Study Identification
Unique Protocol Identification Number
NCT00782990
Brief Title
A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence
Official Title
A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Severo Ochoa
4. Oversight
5. Study Description
Brief Summary
Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress incontinence (SUI).
Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.
Intervention: 24 patients randomised to TVT and 25 to CS.
Detailed Description
Background: Evidence comparing effectiveness of tension-free vaginal tape (TVT) and Burch's colposuspension (CS) in the long term follow-up is weak.
Objective: To compare TVT with CS as primary treatment for stress incontinence (SUI).
Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.
Intervention: 24 patients randomised to TVT and 25 to CS. Measurements: Main outcome: Assessment before treatment and at 6-months, 1-year and 3-years postoperatively with the incontinence severity symptoms index (ISS) and the incontinence impact symptoms index (IIS) Secondary outcome: 3 groups to asses cure rates: cured, improved and failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
stress urinary incontinence, female incontinence, surgical treatment, Female stress urinary incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tvt group
Arm Type
Active Comparator
Arm Description
Surgical treatment for incontinence: TVT
Arm Title
Burch group
Arm Type
Active Comparator
Arm Description
Surgical treatment for incontinence: Colposuspension
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment: TVT
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment: colposuspension
Primary Outcome Measure Information:
Title
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)
Secondary Outcome Measure Information:
Title
Criteria were established to include patients in one of three groups: cure, improved and treatment failure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women between the ages of 35 and 70 who had completed their family with a clinical (Booney test positive) and urodynamic diagnosis of Stress Urinary Incontinence
Previous surgery for prolapse, incontinence or bladder disease, urodynamic diagnosis of detrusor overactivity, or voiding difficulty (defined as maximum flow less than 15 ml/second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 ml)
Cystocele over grade I
Previous hysterectomy
Body mass index (BMI) of 40 or more
Uncontrolled diabetes
Neurological disease
Recurrent urinary tract infections
Genital atrophy precluding vaginal surgery
Known bleeding diathesis or current anticoagulant therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Téllez M Martínez-Fornés, urologist
Organizational Affiliation
Urology department. Hospital severo Ochoa.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Severo Ochoa
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence
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