A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence

NCT00782990 | Completed Phase 4

• 1 other identifier: TVTvsBURCH_2001_HSVO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

stress urinary incontinence; female incontinence; surgical treatment; Female stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)

Secondary Outcomes (1)

• Criteria were established to include patients in one of three groups: cure, improved and treatment failure

Study Arms (2)

tvt group

ACTIVE COMPARATOR

Surgical treatment for incontinence: TVT

Procedure: Surgical treatment: TVT

Burch group

ACTIVE COMPARATOR

Surgical treatment for incontinence: Colposuspension

Procedure: Surgical treatment: colposuspension

Interventions

Surgical treatment: TVT PROCEDURE

tvt group

Surgical treatment: colposuspension PROCEDURE

Burch group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hospital Severo Ochoa: lead

Study Sites (1)

Hospital Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Téllez M Martínez-Fornés, urologist

  Urology department. Hospital severo Ochoa.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: January 1, 2001
• Primary Completion: October 1, 2004
• Study Completion: June 1, 2007
• Last Updated: November 5, 2008

Record last verified: 2008-11

Locations

ES (1)