Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery

April 25, 2023 updated by: kaan baydemir, Ankara University

Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery Using Urogynecologic Ultrasonographic and Urodynamic Evaluation

The patients who underwent mid-urethral sling surgery for stress urinary incontinence will evaluate. The aim of our study is to assess long term surgical outcomes and post operative clinical findings include physical examinations, quality of life questionnaires, ultrasonographic measurements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and Gynecology Department since 2007 will be included.

Primary outcome measure is to describe factors effecting long term success in mid-urethral sling surgery.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey
        • Kaan Baydemir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with underwent mid-urethral surgery in Ankara University Obstetrics and Gynecology Department since 2007 at any age.

Description

Inclusion Criteria:

  • Undergoing surgery in Ankara University Obstetrics and Gynecology Department since 2007
  • Patients come to follow up

Exclusion Criteria:

  • inability in verbal and written communication
  • impairment in cognitive functions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective cure rates
Time Frame: 1-11 years
Objective cure is negative cough stress test.
1-11 years
Subjective cure rates
Time Frame: 1-11 years
Subjective cure is evaluated with PGI-I instrument. Patients who give 'much better' or 'better' response to the PGI question are considered subjectively cured.
1-11 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tape localization
Time Frame: 1-11 years
Length of urethra, length of mesh, distance between urethra and mesh, distance between mesh and bladder neck will be measured. The correlation between these parameters and surgical success will be evaluated
1-11 years
Quality of life(QoL) after surgery
Time Frame: 1-11 years
Impact of surgery on quality of life will be evaluated by QoL questionnaire
1-11 years
Patient satisfaction
Time Frame: 1-11 years
Patient satisfaction will be assessed using a 10-points Visual Analogue Scale (VAS) that ranged from ''complete achievement of my goal'' (10 points) to ''no achievement of my goal'' (0 points). Patient Global Impression of Improvement (PGI-I) and VAS scale correlation will be evaluated.
1-11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

February 2, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29081991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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