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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Notify MeKey information
Conditions
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
Primary outcomes
-
postoperative differences at emotional-behavioral PISQ-12 score
Time frame: 1 year
-
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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