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Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial
Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage \>1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.
Postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 will be 1:1 randomly allocated to Er:YAG laser or watchful waiting group. Participants in the Er:YAG laser group will receive laser therapies at monthly intervals, while participants in the watchful waiting group will receive no treatment. All outcomes in both groups will be evaluated at baseline, 4-months and 6-months from baseline.
Age
All ages
Sex
FEMALE
Healthy Volunteers
Yes
Urogynecological Unit of Alexandra Hospital
Athens, Greece
Start Date
November 30, 2018
Primary Completion Date
December 1, 2019
Completion Date
January 1, 2020
Last Updated
September 17, 2019
30
ACTUAL participants
Erbium Yttrium Aluminum Garnet (Er:YAG) laser
DEVICE
Lead Sponsor
National and Kapodistrian University of Athens
NCT05602246
NCT06902909
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