Transobturator Verus Single Incision Slings
Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial
1 other identifier
interventional
98
0 countries
N/A
Brief Summary
A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2008
Typical duration for not_applicable
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
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedResults Posted
Study results publicly available
July 20, 2023
CompletedJuly 20, 2023
June 1, 2023
2.2 years
November 3, 2015
August 22, 2018
June 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Stress Urinary Incontinence
The primary outcome was presence of leakage during cough stress test(CST) on examination
1 year
Secondary Outcomes (5)
Quality of Life Questionnaire UDI-6
1 year
Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence
1 year
Number of Participants Who Completed Self- Assessment of Cure
1 year
Quality of Life Questionnaire IIQ-7
1 year
Quality of Life Questionnaire ICIQ
1 year
Study Arms (2)
Monarc
ACTIVE COMPARATORPlacement of a transobturator monarc sling for stress urinary incontinence
Mini-arc
EXPERIMENTALPlacement of a single incision mini-arc sling for stress urinary incontinence
Interventions
Eligibility Criteria
You may qualify if:
- Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.
You may not qualify if:
- Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cecilia Calvolead
Related Publications (1)
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PMID: 37888839DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- G W Davila
- Organization
- Cleveland Clinic Florida
Study Officials
- PRINCIPAL INVESTIGATOR
G Willy Davila, MD
Cleveland Clinic Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- coordinator
Study Record Dates
First Submitted
November 3, 2015
First Posted
November 6, 2015
Study Start
November 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
July 20, 2023
Results First Posted
July 20, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share