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

NCT ID: NCT04031807

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-07-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Single-Incision Sling

The women with stress urinary incontinence underwent single-incision sling procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

37 Years

Maximum Eligible Age

78 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maltepe University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BERNA HALILOGLU PEKER, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

MALTEPE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF OB&GYN

Locations

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Maltepe University Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MaltepeU1

Identifier Type: -

Identifier Source: org_study_id