Vaginal HIFU for GSM

JRCT ID: jRCTs032240142

Registered date:06/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Genitourinary syndrome of menopause
• Date of first enrollment: 06/06/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): High intensity focused ultrasound (HIFU) for vagina and vulva

Outcome(s)

• Primary Outcome: Change in VAS of the most bothersome symptom before and after the treatment (percentage change)

Secondary Outcome

1) Change in VAS of each GSM symptom before and after the treatment (percentage change)
2) Change in the Vulvovaginal Symptoms Questionnaire (VSQ) Japanese version before and after the treatment (percentage change)
3) Change in the Female Sexual Function Index (FSFI) Japanese version before and after the treatment (percentage change)
4) Change in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) Japanese version before and after the treatment (percentage change)
5) Change in the Vaginal Health Index (VHI) before and after the treatment (percentage change)
6) Improvement in the POP-Q Classification before and after the treatment (proportion of improvement)
7) Change in vaginal pressure before and after the treatment (percentage change)
8) Change in vaginal pH before and after the treatment (percentage change)
9) Change in vaginal flora (vaginal microbiome) before and after the treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Female

Include criteria

Patients who meet all of the following inclusion criteria are eligible for the study.
1) Patients with one or more of the GSM symptoms
2) Patients aged 18<= and <75 years old
3) Patients who are in good general condition and have a Performance Status (PS) of 0
4) Patients who have received a thorough explanation regarding their participation in this study, and who have given written consent based on a thorough understanding of the study and their own free will
5) Patients who understand and are capable of receiving transvaginal treatment and examination and answering questionnaires including sexual questions conducted in this study
6) Patients who are able to insert a probe into the vaginal canal
7) Patients who are able to make outpatient visits in accordance with the study schedule
8) Patients who have been confirmed to have no cervical neoplasms by cytological or histological examination within 6 months
9) If the patient has been using vaginal or vulvar moisturizers or lubricants, or receiving hormone replacement therapy (systemic or topical), at least 3 months must have passed after the start of such therapy, and their GSM symptom(s) must not have improved sufficiently
10) If the patient has used vaginal or vulvar moisturizer or lubricants, or received hormone replacement therapy (systemic or topical) in the past, at least 3 months must have elapsed since the end of such therapy
11) If a ring (pessary, etc.) has been inserted for pelvic organ prolapse, at least one month must have passed since its removal
12) If the patient has a history of gynecological surgery, at least 6 months must have passed since the surgery, and there must be no problem on gynecological examination
13) If the patient has a history of malignancy, at least 6 months must have passed since the end of treatment, and it must be confirmed that the patient has no evidence of disease (postoperative hormone therapy for breast cancer [LH-RH agonist drugs, tamoxifen, aromatase inhibitors, etc.] is allowed even if the patient is still under such therapy)
14) If the patient has a history of malignancy, the patient's primary physician must give permission for her participation in this study, or the patient must be judged to be completely cured of the malignancy and follow-up must have been completed

Exclude criteria

Patients who meet any of the following criteria are excluded from the study.
1) Patients who are pregnant or possibly pregnant
2) Patients who are postpartum of 6 months or less
3) Patients with undiagnosed abnormal genital bleeding
4) Patients who have an active infection or recurrent infection at the treatment area (vagina or vulva)
5) Patients who have significant inflammation, swelling, or wounding in the treatment area (vagina or vulva)
6) Patients who have neuropathy in the treatment area (vagina or vulva)
7) Patients who have a foreign body (silicone, mesh, ring, etc.) or have received an injection of hyaluronic acid, etc. in the treatment area (vagina or vulva)
8) Patients with an electronic device (pacemaker, implantable cardioverter-defibrillator, etc.) inserted in the body
9) Patients with increased risk of bleeding or bleeding tendency due to anticoagulants, diseases such as thrombocytopenia, or any other reasons
10) Patients who are immunosuppressed or at increased risk of infection due to long-term use of steroids, immunosuppressive drugs, uncontrolled diabetes mellitus, or any other reasons
11) Patients within 6 months after chemotherapy, molecular targeted therapy, or radiotherapy
12) Patients who have received GSM treatment with an energy device in the treatment area (vagina and vulva) in the past
13) Patients with pelvic organ prolapse of POP-Q classification stage III or higher
14) Other patients who are deemed inappropriate to participate in this study by the principal investigator (co-investigator)

Related Information

• Primary Sponsor: Okamoto Aikou
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research (KAKENHI)