Laser Treatment of Genito-urinary Syndrome in Women

NCT03238053 | Withdrawn

• 1 other identifier: Laser treatment
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

laser treatment, randomized trial, menopause, vaginitis, urge

Outcome Measures

Primary Outcomes (1)

• Visual analogue score on vaginal symptoms

  10-cm VAS to measure the overall satisfaction with vaginal symptoms, where the left extreme of the scale indicated ' the worst level of satisfaction ' and the right indicated ' the best level of satisfaction

  three months

Secondary Outcomes (2)

• histopathology

  three months

• microbiology

  three months

Study Arms (8)

Menopausal Laser

ACTIVE COMPARATOR

20 women with vaginal laser treatment

Procedure: Vaginal laser treatment; Device: laser system

Menopausal sham

SHAM COMPARATOR

20 women with probe, no active laser ray

Device: sham

breast cancer laser

ACTIVE COMPARATOR

20 women with breast cancer with vaginal laser treatment

Procedure: Vaginal laser treatment; Device: laser system

breast cancer sham

SHAM COMPARATOR

20 women with breast cancer with vaginal probe, no active laser rays

Device: sham

endometrial cancer laser

ACTIVE COMPARATOR

20 women with endometrial cancer with vaginal laser treatment

Procedure: Vaginal laser treatment; Device: laser system

endometrial cancer sham

SHAM COMPARATOR

20 women with endometrial cancer with vaginal probe, no active laser rays

Device: sham

overactive bladder laser

ACTIVE COMPARATOR

20 women with overactive bladder with vaginal laser treatment

Procedure: Vaginal laser treatment; Device: laser system

Overactive bladder sham

SHAM COMPARATOR

20 women with overactive bladder with vaginal probe, no active laser rays

Device: sham

Interventions

Vaginal laser treatment PROCEDURE

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).

Menopausal Laser; breast cancer laser; endometrial cancer laser; overactive bladder laser

sham DEVICE

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).

Menopausal sham; Overactive bladder sham; breast cancer sham; endometrial cancer sham

laser system DEVICE

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).

Menopausal Laser; breast cancer laser; endometrial cancer laser; overactive bladder laser

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• menopause i.e. age more than 50 years and absence of menstruation for twelve months
• breast cancer
• endometrial cancer
• symptoms of vaginal dryness
• dyspareunia rated as moderate or severe most bothersome symptoms

You may not qualify if:

• acute or recurrent urinary tract infections
• active genital infections i.e. herpes genitalis, candida
• previous reconstructive pelvic surgery
• pelvis organ prolapse stage 2
• any serious disease or chronic condition that could interfere with study compliance except from breast and endometrial cancer
• psychiatric disorders precluding informed consent

Sponsors & Collaborators

• Herning Hospital: lead

Study Sites (1)

Gynecology Dept. Herning Hospital

Herning, 7400, Denmark

Location

Related Publications (4)

• Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.

  PMID: 25333211 BACKGROUND

• Salvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401.

  PMID: 25608269 BACKGROUND

• Athanasiou S, Pitsouni E, Antonopoulou S, Zacharakis D, Salvatore S, Falagas ME, Grigoriadis T. The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women. Climacteric. 2016 Oct;19(5):512-8. doi: 10.1080/13697137.2016.1212006. Epub 2016 Aug 24.

  PMID: 27558459 BACKGROUND

• Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.

  PMID: 40709601 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Endometrial Neoplasms; Urinary Bladder, Overactive; Vaginitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vaginal Diseases

Study Officials

• Sine Jakobsen, MD, PhD

  Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

• Finn F Lauszus

  Herning Hopsital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Laser probe perform similar noise and movement without providing rays
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Research Specialist

Model Details: Four Groups of women randomized for thre months to either laser og sham treatment

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: October 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)