Status:
COMPLETED
Vaginal CO2 Laser for Stress Incontinence
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Stress Incontinence Female
Laser
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Our aim with this study is to determine if transvaginal CO2 laser- treatment (DEKA SmartXide2 Laser System, MonaLisa Touch), renders significant effect in women with SUI. To best test this hypothesis,...
Detailed Description
Patient will be included from our hospital (a Danish academic hospital) among women referred with incontinence. Eligible patients will be randomized to either laser treatment or "sham" laser treatment...
Eligibility Criteria
Inclusion
- Inclusion criteria
- referred from specialist gynecologists or GPs with SUI
- speak and understand Danish
- are found without clinical relevant urogenital prolapse
- older than 18 years of age
- with BMI under 35
- Present with mild to moderate SUI evaluated after ICIQ-UI-SF (slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21))
- Exclusion criteria
- presence of pelvic organ prolapse greater than stage II
- previous pelvic surgery for prolapse or incontinence,
- current infections,
- keloid formation
- vaginal pain
- dyspareunia,
- ICIQ-UI-SF\>=19 (very severe)
- ongoing pregnancy.
Exclusion
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04136652
Start Date
November 1 2019
End Date
February 21 2023
Last Update
October 12 2023
Active Locations (1)
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1
Hvidovre University Hospital
Hvidovre, Denmark, 2650