Vaginal Pessary in Women With Symptomatic Pelvic Organ Prolapse: A Randomized Controlled Trial
Abstract
OBJECTIVE: To compare pelvic floor symptoms, quality of life, and complications in women with symptomatic pelvic organ prolapse (POP) with or without vaginal pessaries in addition to those who do pelvic floor exercises for 12 months. METHODS: This was a parallel-group, single-blind, randomized controlled trial with 12 months of follow-up. Women with symptomatic stage I to stage III POP were randomized to either pelvic floor exercises training (control group) or pelvic floor exercises training and insertion of a vaginal pessary (pessary group). The primary outcome was the change of prolapse symptoms and quality of life by using the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaires. Secondary outcomes included bothersome of prolapse symptoms, desired treatment, and any complications. RESULTS: From December 2011 through November 2014, 311 women were screened and 276 were randomized as follows: 137 to the control and 139 to the pessary group. One hundred thirty-two (95.0%) women in the pessary group and 128 (93.4%) in the control group completed the study. The Pelvic Organ Prolapse Distress Inventory of Pelvic Floor Distress Inventory and the Pelvic Organ Prolapse Impact Questionnaire of Pelvic Floor Impact Questionnaire scores decreased in both groups after 12 months, but the mean score differences were higher in the pessary group (Pelvic Organ Prolapse Distress Inventory: −29.7 compared with −4.7, P <.01; Pelvic Organ Prolapse Impact Questionnaire: −29.0 compared with 3.5, P <.01). Complication rates were low and similar in both groups. CONCLUSION: We provided further evidence in nonsurgical treatment for POP. Prolapse symptoms and quality of life were improved in women using a vaginal pessary in addition to pelvic floor exercises. CLINICAL TRIAL REGISTRATION: Centre for Clinical Research and Biostatistics–Clinical Trials Registry, https://www2.ccrb.cuhk.edu.hk/web/?page_id=746, ChiCTR-TRC-11001796.
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De novo stress urinary incontinence was higher in the pessary group than in the PFMT group, 48% vs 22%, respectively.
“De novo stress urinary incontinence was higher in the pessary group than in the PFMT group, 48% vs 22%, respectively [60].”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [60]
In Cheung et al.-16, there was a significantly higher decrease in POPDI/PFIQ in the pessary group (PFDI-20: -29.7 vs -4.7, P < 0.01; PFIQ: -29.0 vs 3.5, P < 0.01).
“Sign higher decrease in POPDI/PFIQ in pessary group:PFDI-20: -29.7 compared with -4.7, P < 0.01; PFIQ: -29.0 compared with 3.5, P < 0.01)”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [60]
Both Panman et al. (2016) and Cheung et al. (2016) found that pessary fitting fails in a considerable number of women; 40% reported at 12 months.
“Both Panman et al. (2016) [61] and Cheung et al. (2016) [60] found that pessary fitting fails in a considerable number of women; 40% reported at 12 months [60].”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [60]
Two studies found significant differences in favor of pessary use.
“while two studies found significant differences in favor of pessary use.”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [60]
Eight studies found that PFMT improved bladder symptoms and five studies found improvement of anorectal symptoms in women with POP.
“Eight studies found that PFMT improved bladder symptoms [38, 39, 43, 44, 47, 60, 61, 74] and five studies found improvement of anorectal symptoms [39, 43, 44, 47, 61, 74].”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [60]
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“De novo stress urinary incontinence was higher in the pessary group than in the PFMT group, 48% vs 22%, respectively [60].”
BackgroundBugge, C., Kearney, R., Best, C., Goodman, K., Manoukian, S., Melone, L., Dembinsky, M., Mason, H., Elders, A., Graham, M., et al. (2025) · BJOG: An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.18333 · Cited by 6 · see citing works
- Authors
- Cheung, R. Y. K., Lee, J. H. S., Lee, L. L., Chung, T. K. H., & Chan, S. S. C.
- Affiliations
- Chinese University of Hong Kong (HK)
- Venue
- Obstetrics & Gynecology
- Published
- 2016-07
- Volume
- 128
- Issue
- 1
- Pages
- 73-80
- ISSN
- 0029-7844 (ISSN-L)
- OpenAlex
- W2410698549
- Cited by
- 77
- References
- 31
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 7 · 2023: 7 · 2022: 8 · 2021: 10 · 2020: 10 · 2019: 7 · 2018: 12 · 2017: 3 · 2016: 1
- FWCI
- 8.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Obstetrics and Gynecology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Keywords
- pelvic organ prolapse, pessary, pelvic floor muscle training, conservative treatment, prolapse symptoms, quality of life, pessary complications, Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire
- MeSH terms
- Aged, Exercise Therapy, Female, Humans, Middle Aged, Pessaries, Quality of Life, Surveys and Questionnaires, Severity of Illness Index, Treatment Outcome, Pelvic Floor, Pelvic Organ Prolapse, Symptom Assessment
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