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

NCT ID: NCT01426048

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients operated on with the TVT

Gynaecological examination and a supine stress test, questionnaires

Intervention Type OTHER

Gynaecological examination and a supine stress test, questionnaires

Interventions

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Gynaecological examination and a supine stress test, questionnaires

Gynaecological examination and a supine stress test, questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Turku University, Finland

Locations

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Turku university hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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118/180/2008

Identifier Type: -

Identifier Source: org_study_id

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