NCT04031807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

July 22, 2019

Last Update Submit

October 24, 2021

Conditions

Stress Urinary Incontinence

Keywords

Single-Incision SlingStress Urinary IncontinenceFailure

Outcome Measures

Primary Outcomes (1)

  • objective cure

    negative cough stress test

    September 2009 to September 2017

Secondary Outcomes (1)

  • subjective cure

    September 2009 to September 2017

Interventions

Single-Incision SlingPROCEDURE

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

Eligibility Criteria

Age37 Years - 78 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University Faculty of Medicine

Istanbul, 34844, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • BERNA HALILOGLU PEKER, PROFESSOR

    MALTEPE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF OB&GYN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 24, 2019

Study Start

March 1, 2019

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)