Status:
UNKNOWN
The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Pelvic Floor Prolapse
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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 compar...
Eligibility Criteria
Inclusion
- Symptomatic POP, stage II, stage III or stage IV
- Postmenopausal women (patients with serum FSH\>40lu/L; or amenorrhea for 12 months)
- Successfully fit with ring with support pessary
- Ability to attend the clinical trial and follow-up
- Patients and their families understand the study, are willing to participate for up to 1 year and can provide written informed consent
- Willing and able to place vaginal cream
Exclusion
- Acute infection of internal genital tract
- Hormone replacement therapy in recent 3 months
- Suspected or untreated lower genital tract tumor
- Genital fistula
- Abnormally elevated intra-abdominal pressure (eg ascites, tumor, etc)
- Life expectancy less than 1 year
- Vaginal estrogen contraindications, including known or suspected estrogen dependent malignancies (endometrial carcinoma, melanoma), endometrial hyperplasia (thickness of endometrium≥5mm), thrombophlebitis or thromboembolic disease, undiagnosed irregular vaginal bleeding, known or suspected breast cancer, allergy to any component of the estrogen cream and severe liver disease, breast cancer
- The volume of post-voiding residual is more than 250ml. -
Key Trial Info
Start Date :
May 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04393194
Start Date
May 24 2020
End Date
September 1 2022
Last Update
May 19 2020
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