Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence

July 19, 2016 updated by: Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
The investigators think that the two techniques of TOT (inside-out and outside-in) procedures both statistically improve the sexual functions, psychosocial state and quality of life after the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12 were statistically more increase in inside-out group than the outside-in group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pure urodynamic SUI
  • sexual active before and 2 months after the surgery
  • married or single
  • aged over 20
  • have cured after TOT operation

Exclusion Criteria:

  • preoperative or postoperative detrusor disfunction
  • previous history of malignancy
  • prior vaginal surgery
  • a partner with sexual incapabilities
  • a concomitant gynecologic disorder
  • patients with pelvic organ prolapse over stage II
  • pelvic radiotherapy and a history of psychological diseases
  • participants who had no sexual activity with in the past two months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: inside-outside group
inside-out transobturator tape approach
Procedure: transobturator tape
Active Comparator: outside-inside group
outside-in transobturator tape approach
Procedure: transobturator tape

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative differences at emotional-behavioral PISQ-12 score
Time Frame: 1 year
1 year
postoperative differences at physical PISQ-12 score
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Asıcıoglu09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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