Pelvic Floor ProlapsePhase 4NCT04393194
The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse
A Phase 4 study testing Vaginal Cream with Applicator [Dose Form] in people with Pelvic Floor Prolapse, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Floor Prolapse
- What is being tested?
- Vaginal Cream with Applicator [Dose Form]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 24 May 2020to 1 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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. -
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Pelvic Floor Prolapse
- Being tested
- Vaginal Cream with Applicator [Dose Form]
- Keywords
- Vaginal estrogen cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Cream with Applicator [Dose Form]Drug
Also called pessary
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal estrogen cream | Experimental | 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. Receives: Drug: Vaginal Cream with Applicator [Dose Form] |
| vaginal placebo cream | Placebo comparator | 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. Receives: Drug: Vaginal Cream with Applicator [Dose Form] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
- 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.
Measured: up to 1year after randomization
Secondary outcomes (4)
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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Complications will be asked and reported during each follow-up
Measured: up to 1year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start24 May 2020 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor ProlapseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm,Randomized, Double- Blind, Placebo Controlled, Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhulan, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393194
- Sponsor's protocol ID
- ZS-2164
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relying on sharing of online database
Publications
Zhou Y, Yin R, Zhang Y, Wang X, Jin F, Li X, Peng C, Wang P, Shen H, Weng Q, Xie H, Wang H, Jiang B, Zhou K, Liang N, He Y, Dai Y, Fang Z, Liang S, Zhang Y, Morse A, Zhu L. Effects of intravaginal conjugated oestrogen on pessary continuation for pelvic organ prolapse: multicentre, randomised, double blind, placebo controlled trial. BMJ. 2025 Jun 27;389:e084418. doi: 10.1136/bmj-2025-084418.
PubMed 40578851Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.
PubMed 37431855
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04393194
- Acronym / sponsor ID
- ZS-2164
- Conditions
- Pelvic Floor Prolapse
- Keywords
- Vaginal estrogen cream
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 May 2020 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two-arm,Randomized, Double- Blind, Placebo Controlled, Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Vaginal estrogen cream | Experimental | Drug: Vaginal Cream with Applicator [Dose Form]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. |
| vaginal placebo cream | Placebo comparator | Drug: Vaginal Cream with Applicator [Dose Form]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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Cream with Applicator [Dose Form]Also: pessaryPatients 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. | Drug | Vaginal estrogen cream, vaginal placebo cream |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 40578851Zhou Y, Yin R, Zhang Y, Wang X, Jin F, Li X, Peng C, Wang P, Shen H, Weng Q, Xie H, Wang H, Jiang B, Zhou K, Liang N, He Y, Dai Y, Fang Z, Liang S, Zhang Y, Morse A, Zhu L. Effects of intravaginal conjugated oestrogen on pessary continuation for pelvic organ prolapse: multicentre, randomised, double blind, placebo controlled trial. BMJ. 2025 Jun 27;389:e084418. doi: 10.1136/bmj-2025-084418.
- Derived from this study: PubMed 37431855Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.
- Individual participant dataSharing planned: Yes. Relying on sharing of online database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaginal Cream with Applicator [Dose Form] in people with Pelvic Floor Prolapse, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lan Zhu (+86-69156874, zhu_julie@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 1year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393194, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.