Status:
WITHDRAWN
Laser Treatment of Genito-urinary Syndrome in Women
Lead Sponsor:
Herning Hospital
Conditions:
Laser-Induced Scar
Breast Cancer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Women with genitourinary syndrome of menopause, overactive bladder, with breast or endometrial cancer are randomized to either laser treatment og sham treatment for 3 months. The randomization is stra...
Detailed Description
Genitourinary syndrome of menopause (GSM) is characterized by symptoms such as vaginal dryness, dyspareunia, irritation, urinary incontinence, overactive bladder , and urinary tract infections. GSM re...
Eligibility Criteria
Inclusion
- menopause i.e. age more than 50 years and absence of menstruation for twelve months
- breast cancer
- endometrial cancer
- symptoms of vaginal dryness
- dyspareunia rated as moderate or severe most bothersome symptoms
Exclusion
- use of vaginal moisturizers, lubricants or any other local preparation within the thirty days prior to inclusion
- acute or recurrent urinary tract infections
- active genital infections i.e. herpes genitalis, candida
- previous reconstructive pelvic surgery
- pelvis organ prolapse stage 2
- any serious disease or chronic condition that could interfere with study compliance except from breast and endometrial cancer
- psychiatric disorders precluding informed consent
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03238053
Start Date
October 1 2022
End Date
December 31 2026
Last Update
October 16 2024
Active Locations (1)
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1
Gynecology Dept. Herning Hospital
Herning, Denmark, 7400