Evaluation of the MonaLisa Touch procedure in the treatment of postmenopausal vulvovavaginal symptoms

Phase 2

Completed

• Conditions: Postmenopausal symptoms; Genitourinary syndrome of menopause; postmenopausal vulvovaginal symptoms; Vulvovaginal symptoms; Reproductive Health and Childbirth - Menstruation and menopause; Renal and Urogenital - Normal development and function of male and female renal and urogenital system

• Registration Number: ACTRN12616001403426
• Lead Sponsor: GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-10
• Study Completion: 2020-09-30
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

Symptomatic women with any of 1-5:
1.Post-menopausal women who have not had a menstrual period for at least 12 months (with an intact uterus) and/or have vulvovaginal symptoms substantial enough for them to present to their health care provider due to symptoms
2.Women who have previously trialled topical intra-vaginal oestrogen preparations without alleviation of symptoms or with side effects to the treatment
3.Women who have contraindications to topical intra-vaginal oestrogen preparations.
4.Women who have previously had a hysterectomy and have vaginal atrophy symptoms and have an elevation of FSH (>30) consistent with a post-menopausal state.
5.Women who have symptoms of vaginal atrophy and do not wish to use topical oestrogen.

AND have symptoms including one or more of: vaginal dryness; vaginal burning; vaginal itching; dyspareunia or dysuria.

Exclusion Criteria

1.Use of systemic or local hormone replacement therapy in the six months prior to study intervention
2.Use of vaginal moisturisers or other preparations in the 30 days prior to study intervention.
3.Current urinary tract infection.
4.Active genital infections.
5.Current genital herpes infection.
6.Pelvic organ prolapse (most substantial prolapse) POPQ system stage 2.
7.Previous vaginal prolapse surgery where there is mesh repair in the pelvis.
8.Chronic disease states which will interfere with compliance to study

Study & Design

• Study Type: Interventional
• Study Design: Not specified