NCT03949348

Brief Summary

The investigators aimed to evaluate outcomes of transobturator urethral sling placement using autologous rectus fascia for female stress urinary incontinence at perioperatively and at 2-year follow-up.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

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

May 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

May 13, 2019

Last Update Submit

August 23, 2021

Conditions

Stress Urinary IncontinenceSurgery--Complications

Keywords

midurethral sling placementsynthetic meshautologous rectus fasciatransobturator approach

Outcome Measures

Primary Outcomes (1)

  • ICIQ-SF

    The ICIQ-UI Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in women in research and clinical practice across the world. It is scored on a scale from 0-21; higher values represent worse outcomes. The ICIQ-UI Short Form provides a brief and robust measure to assess the impact of symptoms of incontinence on outcome.

    2 years

Secondary Outcomes (1)

  • Treatment Benefit Scale

    2 years

Study Arms (2)

autologous fascia

ACTIVE COMPARATOR

Patients who underwent a transobturator sling placement using autologous rectus fascia

Procedure: Mid-urethral sling placement using autologous rectus fascia

synthetic mesh

ACTIVE COMPARATOR

Patients who underwent a transobturator sling placement using synthetic mesh

Procedure: Mid-urethral sling placement using synthetic mesh

Interventions

Mid-urethral sling placement using autologous rectus fasciaPROCEDURE

Mid-urethral sling placement using autologous rectus fascia

autologous fascia
Mid-urethral sling placement using synthetic meshPROCEDURE

Mid-urethral sling placement using synthetic mesh

synthetic mesh

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSurgery for female stress urinary incontinence
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients that underwent mid-urethral sling placement

You may not qualify if:

  • active urinary infection
  • neurologic disorders
  • malignancies
  • history of radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Linder BJ, Elliott DS. Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term Outcomes. Urology. 2016 Jul;93:55-9. doi: 10.1016/j.urology.2016.03.025. Epub 2016 Mar 29.

    PMID: 27036519RESULT

  • Linder BJ, Elliott DS. Autologous transobturator urethral sling placement for female stress urinary incontinence. J Urol. 2015 Mar;193(3):991-6. doi: 10.1016/j.juro.2014.08.125. Epub 2014 Oct 19.

    PMID: 25444955RESULT

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients who undergo a transobturator sling placement using autologous rectus fascia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal invastigator

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 14, 2019

Study Start

May 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08