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The Outcome of the Transobturator Tape (TOT) Procedure

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01532583
Enrollment
139
Registered
2012-02-14
Start date
2009-01-31
Completion date
2011-10-31
Last updated
2012-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

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.

Interventions

OTHERGynaecological examination, a supine stress test, questionnaires

Gynaecological examination, a supine stress test, questionnaires

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Objective outcome of the TOT operation, which was evaluated with stress test and need for reoperation for urinary incontinence.8 years

Secondary

MeasureTime frame
Subjective outcome of the TOT operation which was assessed with evaluated questionnaires.8 years

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026