Risk Factors for Failure After Single-incision Sling Proc... | NCT04031807

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

NCT04031807

Sponsor

Maltepe University

Status

Completed

Last Update Posted

Oct 26, 2021Actual

Enrollment

132Actual

Phase

Not provided

Conditions

Stress Urinary Incontinence

Interventions

Single-Incision Sling

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Jul 1, 2019Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Jul 22, 2019

First Submission Date that Met QC Criteria

Jul 23, 2019

First Posted Date

Jul 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2021

Last Update Posted Date

Oct 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single-Incision Sling	Procedure	The women with stress urinary incontinence underwent single-incision sling procedure.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

female

Minimum Age

37 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
BERNA HALILOGLU PEKER, PROFESSOR	MALTEPE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF OB&GYN	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maltepe University Faculty of Medicine		Istanbul		34844	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided