The Outcome of the Transobturator Tape (TOT) Procedure

NCT01532583 | Completed

• 1 other identifier: 13/2005, 15.2.2005
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to report the subjective and objective outcome of outside-in transobturator technique (TOT) (Monarc®) in long-term follow-up. This is a follow-up study concerning 191 patients operated on in Turku University Hospital between May 2003 and December 2004 by using TOT. SUI was diagnosed with a positive stress test, the Urinary Incontinence Severity Score (UISS) and the Detrusor Instability Score (DIS). After a mean of 6.5 years evaluation included a gynecological examination and a supine stress test. Subjective outcome was evaluated with UISS, DIS, a visual analogue scale (VAS), a questionnaire of subjective evaluation of continence, EuroQoL-5D, EQ-5D VAS and short versions of IIQ-7 and UDI-6. Objective cure was defined as negative stress test and an absence of reoperation for SUI during the follow-up period.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Objective outcome of the TOT operation, which was evaluated with stress test and need for reoperation for urinary incontinence.

  8 years

Secondary Outcomes (1)

• Subjective outcome of the TOT operation which was assessed with evaluated questionnaires.

  8 years

Study Arms (1)

Patients operated on with the TOT

Other: Gynaecological examination, a supine stress test, questionnaires

Interventions

Gynaecological examination, a supine stress test, questionnaires OTHER

Gynaecological examination, a supine stress test, questionnaires

Patients operated on with the TOT

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

191 female patients with genuine or recurrent stress urinary incontinence or mixed incontinence operated on with the TOT procedure at the mean of 6.5 years ago

You may qualify if:

• patients operated on with the TOT procedure between May 2003 and December 2004 at the Department of Obstetrics and Gynecology in the Turku University Hospital.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku university hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: February 14, 2012
• Study Start: January 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

FI (1)