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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02837796
Other study ID # Asicioglu09
Secondary ID
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


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
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