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Completed

NCT Number: NCT01532583

The Outcome of the Transobturator Tape (TOT) Procedure

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Turku university hospital

Turku, 20521, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 191 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.

Exclusion criteria

Treatment and study plan

Gynaecological examination, a supine stress test, questionnaires

Other

Gynaecological examination, a supine stress test, questionnaires

Primary outcomes

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

    Time frame: 8 years

Secondary outcomes

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

    Time frame: 8 years

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

The Outcome of the Transobturator Tape (TOT) Procedure During the Follow-up of 6.5 Years

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 14, 2012
Registry last updated
Dec 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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