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NCT04031807 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04031807
Other study ID # MaltepeU1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date July 1, 2019

Study information
Verified date October 2021
Source Maltepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 37 Years to 78 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Single-Incision Sling
The women with stress urinary incontinence underwent single-incision sling procedure.

Locations
Country Name City State
Turkey Maltepe University Faculty of Medicine Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary objective cure negative cough stress test September 2009 to September 2017
Secondary subjective cure negative response to Urinary Distress Inventory (UDI-6), question 3. September 2009 to September 2017
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