NCT01426048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

First QC Date

July 25, 2011

Last Update Submit

January 21, 2013

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients operated on with the TVT

Other: Gynaecological examination and a supine stress test, questionnaires

Interventions

Gynaecological examination and a supine stress test, questionnairesOTHER

Gynaecological examination and a supine stress test, questionnaires

Patients operated on with the TVT

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku university hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 25, 2011

First Posted

August 30, 2011

Study Start

November 1, 2008

Study Completion

June 1, 2011

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

FI(1)