The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Pelvic Floor Prolapse

Treatments: Drug: Vaginal Cream with Applicator [Dose Form]

Study type: Interventional

Funder types: Other

Identifiers

NCT04393194

ZS-2164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 2 patient groups, including a placebo group

Vaginal estrogen cream

Experimental group

Description:

subjects will be treated with the prescribed vaginal medication, 1g per time, q d for the first 2 weeks and then 1g per time, twice a week.

Treatment:

Drug: Vaginal Cream with Applicator [Dose Form]

vaginal placebo cream

Placebo Comparator group

Description:

Subjects will be treated with the prescribed vaginal medication, 1g per time, q d for the first 2 weeks and then 1g per time, twice a week.

Treatment:

Drug: Vaginal Cream with Applicator [Dose Form]