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

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ClinicalTrials.gov Identifier: NCT02837796
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Quality of Life Sexual Dysfunction Procedure: transobturator tape Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

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



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Publications of Results:
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Responsible Party: Osman Aşıcıoğlu, medical doctor, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier: NCT02837796    
Other Study ID Numbers: Asıcıoglu09
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016