Long-term Outcome of the TVT Procedure Without Preoperative Urodynamic Examination

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Other: Gynaecological examination and a supine stress test, questionnaires

• Registration Number: NCT01426048
• Lead Sponsor: Turku University Hospital

Brief Summary

A follow-up study of 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital. After a mean of 10.5 years patients were invited to a follow-up visit. Subjective outcome was evaluated with condition-specific and general quality of life and health questionnaires. Objective outcome was evaluated with gynaecological examination and a supine stress test. Objective cure was defined as a negative stress test and no need for a reoperation for SUI and subjective cure.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study Completion: 2011-06
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 138

Inclusion Criteria

• 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients operated on with the TVT	Gynaecological examination and a supine stress test, questionnaires	-

Primary Outcome Measures

Name	Time	Method
Objective outcome of the TVT operation	13.5 years	Objective outcome was measured with negative stress test and no need for reoperation for stress urinary incontinence during the follow-up.

Trial Locations

Locations (1)

Turku university hospital; 🇫🇮 Turku, Finland