Vaginal CO2 Laser for Stress Incontinence

NACompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

November 1, 2019

Primary Completion Date

February 21, 2023

Study Completion Date

February 21, 2023

Conditions
Stress Incontinence FemaleLaser
Interventions
PROCEDURE

CO2 laser- treatment (DEKA SmartXide2 Laser System, MonaLisa Touch

women will receive a series of three treatments using a fractional (pulsed) CO2 laser system (SmartXide2 MonaLisa Touch, DEKA M.E.L.A Srl, Florence, Italy), each performed in an outpatient setting without analgesia. A tubular laser-probe is inserted in the vaginal canal until reaching the vaginal vault. A burst of laser pulses is transmitted through the probe and deflected at 90degrees in four directions towards the vaginal wall, then rotated 45degree for a second burst of pulses. Guided by markings on the probe, it is withdrawn 4mm and the procedure is repeated until reaching the introitus. Treatment parameters include power 30W, dwell time 1000us, 1000um spacing, using normal scan mode, with Smartstack setting for 1 at first application and 3 for the next two applications.

Trial Locations (1)

2650

Hvidovre University Hospital, Hvidovre

All Listed Sponsors
lead

Hvidovre University Hospital

OTHER

NCT04136652 - Vaginal CO2 Laser for Stress Incontinence | Biotech Hunter | Biotech Hunter