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NCT Number: NCT05251220

Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women

Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar lichen sclerosus and pelvic floor muscle reduction.

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Key information

Conditions

Genitourinary Syndrome of Menopause Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Lichen Sclerosus et Atrophicus Lichenoid Eruptions Pelvic Floor Dysfunction Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Urogenital Diseases Vulvar Diseases Vulvar Lichen Sclerosus

Age range

29 year–72 year

Sex eligibility

Female

Study type

Observational

Primary location

Federal Budgetary Healthcare Institution "Volga District Medical Center" of the Federal Medical and Biological Agency

Nizhny Novgorod, Russia,Nighegorodskaya Oblast', Russia

About this study

Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar lichen sclerosus and pelvic floor muscle reduction.

Materials and methods: 60 patients with diseases of the urogenital tract were enrolled into the study; they were treated with a neodymium (ND) laser: three 20-minute sessions every 28 ± 2 days. Efficacy was assessed by means of the Female Sexual Function Index (FSFI), ICIQ-SF, PISQ-12, SF36 survey forms, and a questionnaire to identify urinary disorders at the following time points: before treatment, one month after each session and 6 months after the last procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diseases of the urogenital tract
  • symptoms of genitourinary menopausal syndrome,
  • vulvar lichen sclerosus
  • pelvic floor muscle reduction

Exclusion criteria

  • pregnancy
  • oncological diseases

Treatment and study plan

Primary outcomes

  1. Change in vaginal dryness from baseline

    Time frame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.

    Efficacy was assessed by SF36 quality of life survey form means of the this is a non-specific questionnaire for assessing the patient's quality of life.When 1 point-is the highest result (best),5 points-this is the lowest result (worst).

  2. Change in frequency of involuntary urination (urinary incontinence) from baseline

    Time frame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.

    The effectiveness was assessed using ICIQ-SF (International Urine Retention Index), a subjective indicator of the severity of urine loss and quality of life in patients with urinary incontinence, using the format of questions on a 5-point Likert scale to assess the presence, severity and concomitant symptoms. This is a subjective indicator designed to assess the level, impact and suspected cause of urinary incontinence on the quality of life.5 points-the highest score of the result,0 point- the lowest score of the result.The total amount of points for answering the questions where 0 points - a slight degree of urinary incontinence,19 - 21 - very severe urinary incontinence.

  3. Change in frequency of involuntary urination during physical activities (stress urinary incontinence).

    Time frame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.

    Efficacy was assessed by means of the PISQ12 is a specific and reliable questionnaire consisting of three sections: behavioral and emotional characteristics, physical aspects and questions concerning the patient's relationship with a partner.Each item of the questionnaire contains five possible answers,which are evaluated in points.The result of the survey is expressed by the sum of points on all points.The maximum number of points is48,which is an indicator of the best sexual function. SF36 quality of life survey form means of the this is a non-specific questionnaire for assessing the patient's quality of life.When 1 point-is the highest result (best),5 points-this is the lowest result (worst)

Secondary outcomes

  1. Change in burning pain in the vagina from baseline

    Time frame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.

    Efficacy was assessed by means of the Female Sexual Function Index (FSFI)- a self-controlled questionnaire survey, including 19 items,allows you to evaluate the features of desire,arousal,arousal,orgasm,achieving sexual satisfaction,and the presence of dyspareunia.With the help of this questionnaire,it is possible to conduct a differential assessment of clinical manifestations of sexual disorders.5 points-the highest score of the result,1 point- the lowest score of the result.

Other outcomes

  1. Change in dyspareunia (discomfort during sexual intercourse) from baseline

    Time frame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.

    Efficacy was assessed by means of the Female Sexual Function Index (FSFI)- a self-controlled questionnaire survey, including 19 items,allows you to evaluate the features of desire,arousal,arousal,orgasm,achieving sexual satisfaction,and the presence of dyspareunia.With the help of this questionnaire,it is possible to conduct a differential assessment of clinical manifestations of sexual disorders.5 points-the highest score of the result,1 point- the lowest score of the result.

  2. Change in frequency of sexual activity sensations during sexual intercourse (sensitivity and arousal) from baseline

    Time frame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.

    Efficacy was assessed by means of the Female Sexual Function Index (FSFI)- a self-controlled questionnaire survey, including 19 items,allows you to evaluate the features of desire,arousal,arousal,orgasm,achieving sexual satisfaction,and the presence of dyspareunia.With the help of this questionnaire,it is possible to conduct a differential assessment of clinical manifestations of sexual disorders.5 points-the highest score of the result,1 point- the lowest score of the result.

  3. Change in satisfaction with sex life from baseline

    Time frame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.

    Efficacy was assessed by means of the Female Sexual Function Index (FSFI)- a self-controlled questionnaire survey, including 19 items,allows you to evaluate the features of desire,arousal,arousal,orgasm,achieving sexual satisfaction,and the presence of dyspareunia.With the help of this questionnaire,it is possible to conduct a differential assessment of clinical manifestations of sexual disorders.5 points-the highest score of the result,1 point- the lowest score of the result.

  4. Change in frequency of orgasms during sexual intercourse from baseline

    Time frame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.

    Efficacy was assessed by means of the Female Sexual Function Index (FSFI)- a self-controlled questionnaire survey, including 19 items,allows you to evaluate the features of desire,arousal,arousal,orgasm,achieving sexual satisfaction,and the presence of dyspareunia.With the help of this questionnaire,it is possible to conduct a differential assessment of clinical manifestations of sexual disorders.5 points-the highest score of the result,1 point- the lowest score of the result.

  5. Change in general health condition from baseline

    Time frame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.

    Efficacy was assessed by SF36 quality of life survey form means of the this is a non-specific questionnaire for assessing the patient's quality of life.When 1 point-is the highest result (best),5 points-this is the lowest result (worst) Calculations were made using the Subjective assessment questionnaire on a 10-point scale. Which included questions from each questionnaire:Female Sexual Function Index (FSFI),ICIQ-SF (International Urinary Continence Index), PISQ-12 survey form, SF36 quality of life survey form.

Sponsors and collaborators

Lead sponsor

1st Federal Budgetary Healthcare Institution Volga District Medical Center

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 22, 2022
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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