Genital Laser Treatment in Postmenopausal Patients

NCT05631665 | Active Not Recruiting

• 1 other identifier: ATADEK/2022.11
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Regulation of sexual functions without hormonal support in order to correct the sexual dysfunctions in women with the estrogen hormone lost in the menopausal process. Recently, the reaction to hormonal treatments and the fact that patients with a family history of breast cancer or gynecological cancer cannot receive hormonal treatment have been the reason for applying to alternative treatments. Lubricant treatments are among the treatments that patients have compliance problems in the long term and avoid due to the difficulty of application. Correcting female sexual dysfunctions and post-menopausal women's right to want to feel sexually healthy are the most natural rights. Because sexual dysfunctions cause physiological and psychological problems in women. Thanks to the laser treatment, it is aimed to eliminate the atrophy and sexual dysfunctions of women, thanks to the application of approximately 2 sessions without the need for long-term medication.

Conditions

Dyspareunia; Menopause; Sexual Activity; Atrophy Vulva

Keywords

Fractional CO2 Laser; Vaginal Dryness; Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (2)

• survey results before laser treatment

  Determination of sexual activity rates as points by questionnaire before laser procedure in patients with postmenopausal sexual function problems : Scoring will be done based on survey responses. Sexual Function Index (FSFI) scoring will be used.The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 and the lowest score is 2 after multiplying the coefficients.

  6 months

• survey results after laser treatment

  Determination of sexual activity rates as points by questionnaire after laser procedure in patients with postmenopausal sexual function problems.Scoring will be done based on survey responses. Sexual Function Index (FSFI) scoring will be used.The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 and the lowest score is 2 after multiplying the coefficients.

  6 months

Study Arms (1)

postmenopausal women

EXPERIMENTAL

women with postmenopausal sexual function problems will be the study arm

Other: Survey results before and after laser treatment

Interventions

Survey results before and after laser treatment OTHER

Determination of sexual activity rates as points with a questionnaire before and after laser treatment for patients with postmenopausal sexual function problems.

postmenopausal women

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients in menopause
• have not received previous treatment for sexual problems
• not receiving hormone therapy
• cancer vs. with no history of chemotherapy or radiotherapy
• patients with sound cognitive functions who can answer the questionnaire questions

You may not qualify if:

• menstruating
• cancer treatment recipients
• hormone users --those who do not have sexual activity

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dyspareunia; Sexual Behavior

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; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The group of patients who are in the postmenopausal period and undergo laser treatment for sexual problems. Laser will be applied to the postmenopausal patient group with vaginal dryness and dyspareunia complaints. This group will form the study group. The same surveys will be made before and after the procedure in the 1st month, 3rd month and 6th month. According to the results of the survey, the rate of improvement in sexual problems will be studied.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pinar KADIROGULLARI Assoc.Prof

Model Details: Patients who are in the postmenopausal period and undergo laser treatment for sexual problems

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 30, 2022
• Study Start: December 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

TU (1)