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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426048
First Posted: August 30, 2011
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Turku University Hospital
  Purpose
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.

Condition Intervention Phase
Stress Urinary Incontinence Other: Gynaecological examination and a supine stress test, questionnaires Early Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long-term Outcome of the TVT Procedure Without Preoperative Urodynamic Examination

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Objective outcome of the TVT operation [ Time Frame: 13.5 years ]
    Objective outcome was measured with negative stress test and no need for reoperation for stress urinary incontinence during the follow-up.


Enrollment: 138
Study Start Date: November 2008
Study Completion Date: June 2011
Groups/Cohorts Assigned Interventions
Patients operated on with the TVT Other: Gynaecological examination and a supine stress test, questionnaires
Gynaecological examination and a supine stress test, questionnaires

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
191 female patients with genuine or recurrent stress urinary incontinence or mixed incontinence operated on with the TVT procedure at the mean of 10.5 years ago.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426048


Locations
Finland
Turku university hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
  More Information

Responsible Party: Turku University, Finland
ClinicalTrials.gov Identifier: NCT01426048     History of Changes
Other Study ID Numbers: 118/180/2008
First Submitted: July 25, 2011
First Posted: August 30, 2011
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders