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

Quality of Life Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837796
• Other study ID #: Asicioglu09
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: July 19, 2016
• Start date: September 2013
• Est. completion date: October 2014

Study information

• Verified date: July 2016
• Source: Istanbul Bakirkoy Maternity and Children Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Quality of Life
• Sexual Dysfunction

Intervention

Procedure:
• transobturator tape

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Bakirkoy Maternity and Children Diseases Hospital

References & Publications (1)

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.2014.02.00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative differences at emotional-behavioral PISQ-12 score		1 year	Yes
Primary	postoperative differences at physical PISQ-12 score		1 year	Yes