MedTrace Logo

Vaginal CO2 Laser for Stress Incontinence

NCT04136652 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-10-12

No results posted yet for this study

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, the study will be performed in a prospective, randomised controlled fashion in our institution. We will measure the effect as patient reported improvement using a validated scale (ICIQ-UI SF) as well as an objective measurement (stress test)

Conditions

  • Stress Incontinence Female
  • Laser

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 Guided by markings on the probe, it is withdrawn 4mm and the procedure is repeated until reaching the introitus.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.

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Jeppe B Schroll, MD, PhD · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2023-02-21
Completion
2023-02-21

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04136652 on ClinicalTrials.gov