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CompletedNCT02837796Updated Jul 20, 2016

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

An interventional study of transobturator tape in Quality of Life and Sexual Dysfunction, sponsored by Istanbul Bakirkoy Maternity and Children Diseases Hospital. Completed. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-20.

Sponsored by Istanbul Bakirkoy Maternity and Children Diseases Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Quality of Life
  • Sexual Dysfunction
03

In context

Lead sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • 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

Interventions

  • Proceduretransobturator tape
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Asoglu MR, Selcuk S, Cam C, Cogendez E, Karateke A. Effects of urinary incontinence subtypes on women's quality of life (including sexual life) and psychosocial state. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:187-90. doi: 10.1016/j.ejogrb.2014.02.008. Epub 2014 Feb 15. PubMed 24630299 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02837796
Lead sponsor
Istanbul Bakirkoy Maternity and Children Diseases Hospital
Responsible party
Osman Aşıcıoğlu (medical doctor, Istanbul Bakirkoy Maternity and Children Diseases Hospital) — Principal investigator
First posted
Jul 20, 2016
Start date
Sep 2013
Primary completion
Sep 2014
Completion
Oct 2014
Last update
Jul 20, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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