Pelvic Floor Prolapse Clinical Trial
Official title:
The Effect of Intravaginal Conjugated Estrogen on Ring Pessary Use for Pelvic Organ Prolapse: A Multicenter Randomized, Double- Blind, Placebo Controlled, Clinical Trial
The primary purpose of this two-arm randomized clinical trial is to determine if in women desiring use of a pessary for pelvic organ prolapse (POP) and are successfully fit, if 1-year use and patient impression of improvement is superior in women using vaginal estrogen cream versus those using a vaginal placebo cream.
The study is a multi-center, randomized trial of women with symptomatic utero-vaginal or
post-hysterectomy vaginal vault prolapse desiring non-surgical treatment with a pessary. This
study will compare outcomes in women randomized to vaginal estrogen cream or vaginal placebo
cream.
Women who meet the inclusion/exclusion criteria will be evaluated. A pessary (ring with
support) will be fit by an experienced physician. After successful pessary fitting, they will
be randomly divided into experimental active medication and control groups. The experimental
group will start intravaginal estrogen cream, and the control group will start intravaginal
estrogen-free cream. Then patients will be followed every 3months until 1year.
The purpose of this trial is to evaluate the effect of intravaginal estrogen use on pessary
treatment for pelvic organ prolapse, including short-term and long-term use rate, patient
impression of improvement, improvement in symptom-specific quality of life and complication
incidence.
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