Clinical trial NCT04393194: The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pelvic Floor Prolapse
Keywords: Vaginal estrogen cream
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 420
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm,Randomized, Double- Blind, Placebo Controlled, Clinical Trial
Primary purpose: TREATMENT

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 impression of improvement is superior in women using vaginal estrogen cream versus those using a vaginal placebo cream.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Symptomatic POP, stage II, stage III or stage IV
2. Postmenopausal women (patients with serum FSH\>40lu/L; or amenorrhea for 12 months)
3. Successfully fit with ring with support pessary
4. Ability to attend the clinical trial and follow-up
5. Patients and their families understand the study, are willing to participate for up to 1 year and can provide written informed consent
6. Willing and able to place vaginal cream

Exclusion Criteria:

1. Acute infection of internal genital tract
2. Hormone replacement therapy in recent 3 months
3. Suspected or untreated lower genital tract tumor
4. Genital fistula
5. Abnormally elevated intra-abdominal pressure (eg ascites, tumor, etc)
6. Life expectancy less than 1 year
7. 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
8. The volume of post-voiding residual is more than 250ml. -

Primary outcomes:
measure: The proportion of subjects using the pessary and have very much or much improvement on the patient impression of improvement questionnaire at 1 year between the vaginal estrogen group and the placebo group.
timeFrame: up to 1year after randomization
Secondary outcomes:
measure: 1. Comparison of symptom specific distress (PFDI-20) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.
timeFrame: up to 1year after randomization
measure: 1. Comparison of symptom specific impact (PFIQ-7) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.
timeFrame: up to 1year after randomization
measure: 1. Comparison of sexual function (PISQ-12) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.
timeFrame: up to 1year after randomization
measure: Comparison of the adverse events of subjects wearing a pessary in the vaginal estrogen group and the placebo group at 1 year.
timeFrame: up to 1year after randomization
Other outcomes:
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