The Effect of Intravaginal Conjugated Estrogen on Ring Pessary Use for Pelvic Organ Prolapse: A Multicenter Randomized, Double- Blind, Placebo Controlled, Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 420
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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. -
Arms & Interventions
Vaginal estrogen cream
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.
Intervention: Vaginal Cream with Applicator [Dose Form] (Drug)
vaginal placebo cream
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.
Intervention: Vaginal Cream with Applicator [Dose Form] (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: up to 1year after randomization
1. Sustained wearing with satisfaction: continuous wearing is defined as the use of the pessary after successful fitting test. The continuous wearing time interval is from the start of wearing the pessary to cessation of pessary use. 2. PGI-I （patient global impression of improvement））is used to evaluate patient impression of improvement. PGI-I is divided into seven levels: very much better, much better, a little bit better, no change, a little bit worse, much worse and very much worse. The patient's response of" very much better" and" much better" is defined as a successful impression of improvement.
Secondary Outcomes
- 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.(up to 1year after randomization)
- 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.(up to 1year after randomization)
- Comparison of the adverse events of subjects wearing a pessary in the vaginal estrogen group and the placebo group at 1 year.(up to 1year after randomization)
- 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.(up to 1year after randomization)
Investigators
zhulan
Director of general gynecology Center
Peking Union Medical College Hospital