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NCT01426048 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01426048
Other study ID # 118/180/2008
Secondary ID
Status Completed
Phase Phase 0
First received July 25, 2011
Last updated January 21, 2013
Start date November 2008
Est. completion date June 2011

Study information
Verified date January 2013
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority Ethics Committee of the Hospital District of Southwest, Finland':'
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 138
Est. completion date June 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Gynaecological examination and a supine stress test, questionnaires
Gynaecological examination and a supine stress test, questionnaires

Locations
Country Name City State
Finland Turku university hospital Turku

Sponsors (1)
Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective outcome of the TVT operation Objective outcome was measured with negative stress test and no need for reoperation for stress urinary incontinence during the follow-up. 13.5 years
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