A 3 Year Follow-up Prospective Open Randomized Trial of T... | NCT00782990

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

NCT00782990

Sponsor

Hospital Severo Ochoa

Status

Completed

Last Update Posted

Nov 5, 2008Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Urinary Incontinence

Interventions

Surgical treatment: TVT
Surgical treatment: colposuspension

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Oct 2004Actual

Completion Date

Jun 2007Actual

First Submitted Date

Oct 30, 2008

First Submission Date that Met QC Criteria

Oct 30, 2008

First Posted Date

Oct 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2008

Last Update Posted Date

Nov 5, 2008Estimated

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Surgical treatment: TVT	Procedure		tvt group
Surgical treatment: colposuspension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)

Secondary Outcomes

Measure	Description	Time Frame
Criteria were established to include patients in one of three groups: cure, improved and treatment failure

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Téllez M Martínez-Fornés, urologist	Urology department. Hospital severo Ochoa.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Severo Ochoa		Leganés	Madrid	28911	Spain

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided