- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04393194
The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse
The Effect of Intravaginal Conjugated Estrogen on Ring Pessary Use for Pelvic Organ Prolapse: A Multicenter Randomized, Double- Blind, Placebo Controlled, Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Lan Zhu
- Phone Number: +86-69156874
- Email: zhu_julie@vip.sina.com
Study Contact Backup
- Name: Ying Zhou
- Phone Number: +86-69156204
- Email: shellypumch@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Patients with symptomatic POP will be assigned as outpatients.
After the initial pessary fitting, the patients will be followed up in 2 weeks.
If the prolapse is supported, no discomfort, and the patient decides to continue to use the pessary, the pessary fitting is successful.
Patients with successful ring pessary fitting, who agree to participate and sign written consent, will be randomized into the vaginal estrogen group and the placebo group.
The patients will be followed up every 3 months after wearing pessary combined with vaginal medication, until 1 year after wearing the pessary.
Other Names:
|
Placebo Comparator: 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.
|
Patients with symptomatic POP will be assigned as outpatients.
After the initial pessary fitting, the patients will be followed up in 2 weeks.
If the prolapse is supported, no discomfort, and the patient decides to continue to use the pessary, the pessary fitting is successful.
Patients with successful ring pessary fitting, who agree to participate and sign written consent, will be randomized into the vaginal estrogen group and the placebo group.
The patients will be followed up every 3 months after wearing pessary combined with vaginal medication, until 1 year after wearing the pessary.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
|
up to 1year after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: up to 1year after randomization
|
Questionnaire survey: Relief of symptoms using validated instruments, Pelvic Floor Distress Inventory-20 。PFDI-20 scores 0-300, The higher the score is, the more serious the symptoms of PFD are, the greater the impact on the life of the patients.
|
up to 1year after randomization
|
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.
Time Frame: up to 1year after randomization
|
Questionnaire survey: Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.
|
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.
Time Frame: up to 1year after randomization
|
Questionnaire survey: Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.
|
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.
Time Frame: up to 1year after randomization
|
Complications will be asked and reported during each follow-up
|
up to 1year after randomization
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZS-2164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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