Evidence map›Paper›PMID 40578851›Full record

Trial reportBMJ (Clinical research ed.)2025

Effects of intravaginal conjugated oestrogen on pessary continuation for pelvic organ prolapse: multicentre, randomised, double blind, placebo controlled trial.

Ying Zhou, Rusha Yin, Yuelun Zhang, Xuemei Wang, Fengbin Jin, Xiangjuan Li, Cheng Peng, Ping Wang, Haiyan Shen, Qiao Weng and 12 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04393194 (The Effect of Intravaginal Conjugated Estrogen on Ring Pessary Use for Pelvic Organ Prolapse), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04393194 phase4unknown statusnot on this map

The Effect of Intravaginal Conjugated Estrogen on Ring Pessary Use for Pelvic Organ Prolapse: A Multicenter Randomized, Double- Blind, Placebo Controlled, Clinical Trial

TypeinterventionalSponsorPeking Union Medical College HospitalRan2020 to 2022Enrolled420ConditionsPelvic Floor ProlapseArmsVaginal Cream with Applicator [Dose Form]
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Ying ZhouDepartment of Obstetrics and Gynecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Common Mechanism Research for Major Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Rusha YinDepartment of Obstetrics and Gynecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Common Mechanism Research for Major Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Yuelun ZhangCenter for Prevention and Early Intervention, National Infrastructures for Translational Medicine, Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Xuemei WangDepartment of Obstetrics and Gynecology, Tangshan Maternity and Child Health Care Hospital, Tangshan, Hebei, China.
Fengbin JinDepartment of Obstetrics and Gynecology, Women and Children's Hospital of Jinzhou, Jinzhou, Liaoning, China.
Xiangjuan LiDepartment of Obstetrics and Gynecology, Hangzhou Women's Hospital, Hangzhou, Zhejiang, China.
Cheng PengDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of University of Science and Technology of China (USTC), Hefei, Anhui, China.
Ping WangDepartment of Obstetrics and Gynecology, Sichuan University West China Second Hospital, Key Laboratory of Birth Defects and Related Diseases of Women and Children of Ministry of Education, Chengdu, Sichuan, China.
Haiyan ShenDepartment of Obstetrics and Gynecology, Huai'an Maternal and Child Health Care Center, Huai'an, Jiangsu, China.
Qiao WengDepartment of Obstetrics and Gynecology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.
Hongbin XieDepartment of Obstetrics and Gynecology, Xiamen Maternal and Child Health Hospital, Xiamen, Fujian, China.
Hong WangDepartment of Obstetrics and Gynecology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
Bengui JiangDepartment of Obstetrics and Gynecology, Women and Children's Hospital of Ningbo University, Ningbo, Zhejiang, China.
Kai ZhouDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.
Nannan LiangDepartment of Obstetrics and Gynecology, Tangshan Maternity and Child Health Care Hospital, Tangshan, Hebei, China.
Yinghui HeDepartment of Obstetrics and Gynecology, Women and Children's Hospital of Jinzhou, Jinzhou, Liaoning, China.
Yingying DaiDepartment of Obstetrics and Gynecology, Hangzhou Women's Hospital, Hangzhou, Zhejiang, China.
Zheng FangDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of University of Science and Technology of China (USTC), Hefei, Anhui, China.
Shuo LiangDepartment of Obstetrics and Gynecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Common Mechanism Research for Major Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Yiwei ZhangDepartment of Obstetrics and Gynecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Common Mechanism Research for Major Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Abraham MorseDepartment of Community Medicine and Public Health, Tufts University School of Medicine, Boston, MA, USA.
Lan ZhuDepartment of Obstetrics and Gynecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Common Mechanism Research for Major Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.ORCID 0000-0001-5753-5426

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine the effect of vaginal oestrogen cream on pessary continuation rates in pelvic organ prolapse.

designMulticentre, randomised, double blind, placebo controlled trial.

setting12 academic medical centres in China (May 2020-June 2023).

participantsPostmenopausal women with symptomatic pelvic organ prolapse ≥stage 2 and successfully fitted with ring pessaries were randomly assigned in a 1:1 ratio to receive oestrogen cream or placebo cream.

interventionsOne gram of conjugated oestrogen cream (0.625 mg/g) or placebo cream was inserted vaginally every night for the first two weeks after successful pessary fitting followed by twice weekly for 12 months.

main outcome measuresThe primary outcome was the pessary continuation rate with satisfaction, which was defined as the proportion of participants who continued using the pessary and reported a response of very much better or much better on the Patient Global Impression of Improvement questionnaire at 12 months. Secondary outcomes included self-reported pelvic floor symptoms and adverse events. All analyses were based on a modified intention-to-treat approach, including participants who had at least one visit.

resultsOf 420 postmenopausal women randomised, 411 had at least one visit and were included in the modified intention-to-treat analysis (208 in the vaginal oestrogen group and 203 in the placebo group). The mean age of participants was 66 years. Pessary continuation rate with satisfaction did not differ significantly between the oestrogen group and the placebo group (181/208 (87.0%)

conclusionsOestrogen cream did not improve the continuation rate of ring pessary use with satisfaction. Use of oestrogen cream might be associated with a lower risk of common adverse events. The clinical decision to use vaginal oestrogen should take into account its benefits and risks and the patient's personal preferences.

trial registrationClinicalTrials.gov NCT04393194.

Indexed as

EstrogensEstrogens, Conjugated (USP)Pelvic Organ ProlapsePessariesAdministration, IntravaginalAgedChinaDouble-Blind MethodFemaleHumansMiddle AgedPatient SatisfactionPostmenopauseTreatment OutcomeVaginal Creams, Foams, and JelliesEstrogensEstrogens, Conjugated (USP)Vaginal Creams, Foams, and Jellies

Identifiers

PMID40578851
PMCPMC12310159

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.