Laser Therapy Following Radiotherapy for Gynecological Cancer

NCT03714581 | Unknown

• 1 other identifier: 143/21-03-2018
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.

Conditions

Pelvic Radiotherapy; Gynecological Cancer; Dyspareunia; Vaginal Dryness

Outcome Measures

Primary Outcomes (1)

• 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness

  It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness

  Change from baseline at 1 month post-treatment

Secondary Outcomes (10)

• 3 days voiding diary

  Change from baseline at 1 month post-treatment

• Day-to Day Impact of vaginal aging questionnaire (DIVA)

  Change from baseline at 1 month post-treatment

• The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) cervical cancer module (CX24)

  Change from baseline Quality of Life questionnaire (QLQ) cervical cancer module (CX24) at 1-month post-treatment

• Patients Global Impression of Improvement

  At 1-month post-treatment

• International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)

  Change from baseline International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) at 1-month post-treatment

Study Arms (2)

Laser

EXPERIMENTAL

Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)

Device: Microablative Fractional CO2 Laser Therapy

Placebo

PLACEBO COMPARATOR

Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.

Device: Microablative Fractional CO2 Laser Therapy

Interventions

Microablative Fractional CO2 Laser Therapy DEVICE

5 laser therapies intravaginally administered will be applied at monthly intervals.

Also known as: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy

Laser; Placebo

Eligibility Criteria

• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• History of gynecological cancer treated with pelvic radiotherapy
• last radiotherapy \>1 year
• women sexually active or willing to resume sexual activity
• symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse

You may not qualify if:

• Relapse of gynecological cancer
• prolapse stage \>1
• active genital infection (i.e herpes, vaginitis)
• underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Urogynecological Unit of Alexandra Hospital

Athens, 11528, Greece

RECRUITING

Related Publications (2)

• 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

• Athanasiou S, Pitsouni E, Grigoriadis T, Michailidis G, Tsiveleka A, Rodolakis A, Loutradis D. A study protocol of vaginal laser therapy in gynecological cancer survivors. Climacteric. 2020 Feb;23(1):53-58. doi: 10.1080/13697137.2019.1646720. Epub 2019 Sep 2.

  PMID: 31474161 DERIVED

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Stavros Athanasiou, Associate Proffesor

  National and Kapodistrian University of Athens, Greece

  STUDY DIRECTOR

Central Study Contacts

Stavros Athanasiou, Associate Professor

CONTACT

+306944478555; stavros.athanasiou@gmail.com

Eleni Pitsouni, MD, MSc

CONTACT

+306976829710; elinapitsouni@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant Professor

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 22, 2018
• Study Start: November 15, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

GR (1)