Laser Treatment of Genito-urinary Syndrome in Women

Summary

Women with genitourinary syndrome of menopause, overactive bladder, with breast or endometrial cancer are randomized to either laser treatment og sham treatment for 3 months. The randomization is stratified for estrogen treatment. The effect is evaluated by questionnaire, histology and microbiology swaps

Conditions

• Laser-Induced Scar
• Breast Cancer
• Endometrial Cancer
• Menopause
• Vaginal Atrophy
• Bladder, Overactive

Interventions

PROCEDURE

Vaginal laser treatment

Fractional CO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).

DEVICE

sham

Fractional CO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).

DEVICE

laser system

FractionalCO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).

Sponsors & Collaborators

• Herning Hospital

  lead OTHER

Principal Investigators

• Sine Jakobsen, MD, PhD · Randers Regional Hospital

• Finn F Lauszus · Herning Hopsital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• Denmark

Study Locations