NCT02837796

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

July 12, 2016

Last Update Submit

July 19, 2016

Conditions

Quality of LifeSexual Dysfunction

Outcome Measures

Primary Outcomes (2)

  • postoperative differences at emotional-behavioral PISQ-12 score

    1 year

  • postoperative differences at physical PISQ-12 score

    1 year

Study Arms (2)

inside-outside group

ACTIVE COMPARATOR

inside-out transobturator tape approach

Procedure: transobturator tape

outside-inside group

ACTIVE COMPARATOR

outside-in transobturator tape approach

Procedure: transobturator tape

Interventions

transobturator tapePROCEDURE
inside-outside groupoutside-inside group

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pure urodynamic SUI
  • sexual active before and 2 months after the surgery
  • married or single
  • aged over 20
  • have cured after TOT operation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.2014.02.008. Epub 2014 Feb 15.

    PMID: 24630299RESULT

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 20, 2016

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

July 20, 2016

Record last verified: 2016-07