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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02837796

Enrollment

101

Registered

2016-07-20

Start date

2013-09-30

Completion date

2014-10-31

Last updated

2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Sexual Dysfunction

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.

Interventions

PROCEDUREtransobturator tape

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
postoperative differences at emotional-behavioral PISQ-12 score	1 year
postoperative differences at physical PISQ-12 score	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026