N/A
N=98
Transobturator Verus Single Incision Slings
Urinary Incontinence, Stress
Bottom Line
View on ClinicalTrials.gov: NCT02599051 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Objective Stress Urinary Incontinence — 9; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mini-arc (Device); Monarc (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cecilia Calvo
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Stress Urinary Incontinence |
9; 12 | — |
| SECONDARY Quality of Life Questionnaire UDI-6 |
15.1; 20.3 | — |
| SECONDARY Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence |
11; 21 | — |
| SECONDARY Number of Participants Who Completed Self- Assessment of Cure |
37; 31 | — |
| SECONDARY Quality of Life Questionnaire IIQ-7 |
8.95; 12.7 | — |
| SECONDARY Quality of Life Questionnaire ICIQ |
3.1; 3.9 | — |
Summary
A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling
Eligibility Criteria
Inclusion Criteria
- Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.
Exclusion Criteria
- Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
Data sourced from ClinicalTrials.gov (NCT02599051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.