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OpenTrials
Completed

NCT Number: NCT02837796

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

transobturator tape

Procedure

Primary outcomes

  1. postoperative differences at emotional-behavioral PISQ-12 score

    Time frame: 1 year

  2. postoperative differences at physical PISQ-12 score

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 20, 2016
Registry last updated
Jul 20, 2016

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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