Recently, a study led by Professor Zhu Lan, Director of the Department of Obstetrics and Gynecology at PUMCH, investigating the effects of intravaginal oestrogen on pessary use in patients with pelvic organ prolapse (POP), was published online in the international top-tier medical journal The BMJ. The study results showed that when treating POP patients with pessary, the combined use of intravaginal oestrogen does not improve the pessary continuation rate with satisfaction, but may reduce pessary-related complications. This study provides high-level evidence for optimizing pessary treatment management for POP.

Approximately 15% of postmenopausal women in China have symptomatic POP, which severely affects their quality of life. As population aging advances, this proportion will continue to rise. A pessary is a medical device that fits into the vagina and supports vaginal tissues affected by POP. Pessary use is currently a first-line option for POP. However, due to potential adverse events such as increased discharge and vaginal ulcers, approximately 24%-49% of women discontinue pessary use within 1-2 years. Vaginal oestrogen can improve the atrophic state of postmenopausal vaginal mucosa and accelerate mucosal repair. Therefore, in clinical practice, physicians prophylactically add vaginal oestrogen for postmenopausal pessary users. However, given the limited high-quality evidence and concerns about potential risks, costs, and inconvenience associated with routine oestrogen use, clinical guidelines and consensus statements both domestically and internationally remain divided on vaginal oestrogen recommendations.

To address these issues, the Department of Obstetrics and Gynecology at PUMCH led a collaboration with 11 hospitals nationwide to conduct a randomised, multicentre, double blind, placebo controlled trial starting in 2020. Over a span of nearly 5 years, the study enrolled 420 postmenopausal patients using a pessary for symptomatic POP. Participants were randomised 1:1 to receive vaginal conjugated oestrogen cream or placebo cream twice per week, with follow-up to 1 year after fitting. The two products were identical in appearance.

The study results showed that both groups had high treatment compliance. Pessary continuation rate with satisfaction did not differ significantly between the oestrogen group and the placebo group, which were 87.0% and 86.7% respectively. Patients in the oestrogen group had lower risks of pessary-related complications including excessive discharge, erosion or ulcer, and bleeding. In the oestrogen group, excessive discharge was reported by 16.3% of the participants, vaginal erosion or ulcer by 1.9% of the participants, and vaginal bleeding by 1.4% of the participants; in the placebo group, these percentages were 25.6%, 6.9%, and 6.4%, respectively. In addition, intravaginal oestrogen did not increase the risk of thrombosis or endometrial thickening.

The research conclusion is that oestrogen cream did not improve the continuation rate of pessary use with satisfaction. Use of oestrogen cream might be associated with a lower risk of common adverse events. Clinical decision-making for pessary management has historically lacked robust evidence, with most decisions relying on physician training and clinical experience. This study represents China's first large-scale randomized controlled trial examining pessary use, providing for the first time high-quality evidence to clarify the role of vaginal oestrogen in POP pessary treatment. It is expected to further optimize pessary management and provide scientific evidence for improving patient treatment compliance, reducing complications, and alleviating unnecessary medical burden. Professor Zhu Lan stated that for female patients’ health, the clinical decision to use vaginal oestrogen should be individualized, taking into account its benefits and risks and the patient’s personal preferences.

Professor Zhu Lan, Director of the Department of Obstetrics and Gynecology at PUMCH, and Professor Abraham Morse from the School of Community Medicine and Public Health at Tufts University, USA, are co-corresponding authors of this paper. Dr. Zhou Ying, Associate Chief Physician, and Dr. Yin Rusha from the Department of Obstetrics and Gynecology at PUMCH, and Assistant Researcher Zhang Yuelun from the Center for Prevention and Early Intervention are co-first authors of this paper.

Written by Zhou Ying and Chen Xiao