Intravaginal conjugated oestrogen does not improve continuation rate of ring pessary use

1. Oestrogen cream did not improve the continuation rate of ring pessary use and satisfaction among postmenopausal women with pelvic organ prolapse (POP) compared to placebo.

2. Participants who received oestrogen cream reported less common adverse events such as excessive discharge, vaginal erosion or ulcer, and vaginal bleeding.

Evidence Rating Level: 1 (Excellent)

Pelvic organ prolapse (POP) is a common condition among postmenopausal women, involving the descent of pelvic organs into or past the vaginal opening. Although pessary treatment is commonly recommended for managing symptomatic POP, 24-49% of women discontinued its use within 12-24 months due to adverse events such as excessive discharge, discomfort, and vaginal ulcers. As oestrogen can relieve genitourinary syndrome of menopause and help treat vaginal ulcers, its use may help optimize long-term pessary use. Given the limited research on the effects of oestrogen on long-term pessary use, this study examined the efficacy of intravaginal oestrogen cream vs placebo cream in the pessary treatment outcomes for POP. This was a multicenter, randomized, double blind, placebo-controlled trial conducted in 12 hospitals across China between May 2020-June 2023. Postmenopausal women with symptomatic POP (≥ stage 2) and successfully fitted with ring pessaries were included. Participants were randomly assigned 1:1 to receive vaginal conjugated oestrogen cream (0.625 mg/g) or placebo cream every night for the first two weeks after successful pessary fitting followed by twice weekly for 12 months. The composite primary outcome was pessary continuation (> five days a week) and a response of very much better or much better to the Patient Impression of Improvement (PGI-I) questionnaire at 12 months. Out of 420 postmenopausal women randomized, 411 participants were analyzed, of which 208 were in the vaginal oestrogen group (mean [SD] age, 66 [7.4] years; mean [SD] body mass index (BMI), 23.7 [2.7] kg/m2) and 203 were in the placebo group (mean [SD] age, 66 [7.4] years; mean [SD] body mass index (BMI), 24.1 [2.4] kg/m2). There was no significant difference in pessary continuation rate with satisfaction between the oestrogen group and the placebo group (181/208 (87.0%) vs 176/203 (86.7%); risk difference 0.3%, 95% confidence interval (CI) −6.2% to 6.9%; P=0.92). Compared to the placebo group, the oestrogen group had fewer reports of excessive discharge (34/208 (16.3%) vs 52/203 (25.6%); −9.3%, −17.1% to −1.4%), vaginal erosion or ulcer (4/208 (1.9%) vs 14/203 (6.9%); −5.0%, −8.9% to −1.0%), and vaginal bleeding (3/208 (1.4%) vs 13/203 (6.4%); −5.0%, −8.7% to −1.2%). Overall, this study found that oestrogen cream did not improve the continuation rate of ring pessary use and satisfaction, although it may be associated with lower risk of common adverse events. Future longer-term studies are needed to confirm study findings. 

Click to read the study in BMJ

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