Risk Factors for Failure After Single-incision Sling Procedure in Women With Stress Urinary Incontinence

October 24, 2021 updated by: Maltepe University

Risk Factors for Failure After Single-incision Sling Procedure. Retrospective Analysis of 132 Women

The main risk factors for failure after single-incision slings are reduced urethral mobility and stress urinary incontinence severity in long-term follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The medical records of the 132 patients were retrospectively analyzed. Preoperative assessment included medical history and urogynecological examination. Patients were asked to answer validated questionnaires such as Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Objective cure of SUI was defined as the absence of demonstrable leakage of urine on the cough stress test. Subjective cure was based on negative response to UDI-6, question 3. Patients were divided according to objective cure rate into two groups: cured (Group A) and failed patients (Group B).

Study Type

Observational

Enrollment (Actual)

132

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
      • İstanbul, Turkey, 34844
        • Maltepe University Faculty of Medicine

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

37 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

From September 2009 to September 2017, the medical records of the patients who underwentsingle-incision sling procedure for stress urinary incontinence without concomitant pelvic prolapse surgery were analyzed.

Description

Inclusion Criteria:

Women who underwent single-incision sling procedure for stress urinary incontinence

Exclusion Criteria:

Urodinamically proven detrusor overactivity

Neurogenic bladder

Previous anti-incontinence surgery including midurethral slings

Postvoidal residual volume (PVR) >100mL

Previous radical pelvic surgery

Anterior pelvic organ prolapse greater than stage I

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective cure
Time Frame: September 2009 to September 2017
negative cough stress test
September 2009 to September 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective cure
Time Frame: September 2009 to September 2017
negative response to Urinary Distress Inventory (UDI-6), question 3.
September 2009 to September 2017

Collaborators and Investigators

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

Sponsor

Maltepe University

Investigators

  • Principal Investigator: BERNA HALILOGLU PEKER, PROFESSOR, MALTEPE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF OB&GYN

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)

March 1, 2019

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MaltepeU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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