Genitourinary Syndrome of MenopauseNCT05251220
Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women
An observational study of Genitourinary Syndrome of Menopause and Pelvic Floor Dysfunction, run by 1st Federal Budgetary Healthcare Institution Volga District Medical Center at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 29 to 72 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause, Pelvic Floor Dysfunction, Vulvar Lichen Sclerosus
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2018to 24 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 72 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with diseases of the urogenital tract were enrolled into the study;women with symptoms of genitourinary menopausal syndrome, vulvar lichen sclerosus and pelvic floor muscle reduction
Who may be able to join
- diseases of the urogenital tract
- symptoms of genitourinary menopausal syndrome,
- vulvar lichen sclerosus
- pelvic floor muscle reduction
Who cannot join
- pregnancy
- oncological diseases
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Budgetary Healthcare Institution "Volga District Medical Center" of the Federal Medical and Biological Agency
Nizhny Novgorod, Russia,Nighegorodskaya Oblast'
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.
Read the detailed description
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.
- Keywords
- neodymium laser, GUMS, lichen sclerosus
- Medical subject headings
- Vulvar Lichen Sclerosus, Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 10 women with objectively confirmed vulvovaginal atrophy | 10 women with objectively confirmed vulvovaginal atrophy (genitourinary menopausal syndrome | |
| 37 women with 1-2 degree prolapse of the vaginal walls combined with stress urinary incontinence | 37 women with 1-2 degree prolapse of the vaginal walls combined with stress urinary incontinence | |
| 7 with vaginal relaxation syndrome | 7 with vaginal relaxation syndrome | |
| 6 with vulvar lichen sclerosus | 6 with vulvar lichen sclerosus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vaginal dryness from baseline
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).
Measured: 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.
Change in frequency of involuntary urination (urinary incontinence) from baseline
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.
Measured: 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.
Change in frequency of involuntary urination during physical activities (stress urinary incontinence).
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)
Measured: 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.
Secondary outcomes (1)
Change in burning pain in the vagina from baseline
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Jan 2018
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- 1st Federal Budgetary Healthcare Institution Volga District Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pauzina Olga Alexandrovna, 1st Federal Budgetary Healthcare Institution Volga District Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251220
- Sponsor's protocol ID
- 29.10№14
- Status last verified
- Feb 2022
- First submitted
- 12 Dec 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol,Statistical Analysis Plan (SAP).
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women
- ClinicalTrials.gov ID
- NCT05251220
- Acronym / sponsor ID
- 29.10№14
- Keywords
- neodymium laser, GUMS, lichen sclerosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- 1st Federal Budgetary Healthcare Institution Volga District Medical CenterOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 women with objectively confirmed vulvovaginal atrophy | – | –10 women with objectively confirmed vulvovaginal atrophy (genitourinary menopausal syndrome |
| 37 women with 1-2 degree prolapse of the vaginal walls combined with stress urinary incontinence | – | –37 women with 1-2 degree prolapse of the vaginal walls combined with stress urinary incontinence |
| 7 with vaginal relaxation syndrome | – | –7 with vaginal relaxation syndrome |
| 6 with vulvar lichen sclerosus | – | –6 with vulvar lichen sclerosus |
Who may qualify
- Ages
- 29 to 72 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with diseases of the urogenital tract were enrolled into the study;women with symptoms of genitourinary menopausal syndrome, vulvar lichen sclerosus and pelvic floor muscle reduction
Key inclusion criteria (4 listed)
- diseases of the urogenital tract
- symptoms of genitourinary menopausal syndrome,
- vulvar lichen sclerosus
- pelvic floor muscle reduction
Key exclusion criteria (2 listed)
- pregnancy
- oncological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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)
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: Yes. Study Protocol,Statistical Analysis Plan (SAP).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genitourinary Syndrome of Menopause and Pelvic Floor Dysfunction, run by 1st Federal Budgetary Healthcare Institution Volga District Medical Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.