Are pessaries effective in treating pelvic organ prolapse in women?
Pessaries combined with pelvic floor muscle training (PFMT) probably improve pelvic organ prolapse symptoms in women (number needed to treat [NNT] = 3; 95% CI, 2 to 6) and prolapse-specific quality of life compared with PFMT alone. However, the risk of adverse events (abnormal vaginal bleeding) may be higher (number needed to harm [NNH] = 27; 95% CI, 5 to 111).1 (Strength of Recommendation: B, based on inconsistent or limited-quality patient-oriented evidence.)
Pelvic organ prolapse is characterized by pelvic organs such as the uterus, bladder, or bowel protruding into the vagina because of pelvic floor muscle weakness. Common symptoms include a feeling of “something coming down,” vaginal or pelvic pain, urinary and/or bowel symptoms, and sexual difficulties, and these can significantly worsen patient quality of life.2 About 40% of women older than 40 years are affected,3 and the prevalence is expected to increase as the population ages. Treatment options include pessaries, PFMT, and surgery. Clinicians commonly offer pessaries as first-line treatment. The authors of this review aimed to determine the effect of pessaries in the management of pelvic organ prolapse.
This Cochrane review included four randomized controlled trials involving 478 women with a mean age of 30.4 to 65.6 years at various stages of prolapse and follow-up ranging from six weeks to two years.1 One trial compared the use of a pessary with no intervention, the second compared a pessary and PFMT, the third compared pessary and surgery, and the fourth trial compared pessary plus PFMT with PFMT alone. Improvement of prolapse symptoms was measured using the validated Pelvic Floor Disability Index or the Pelvic Organ Prolapse Symptom Score. Prolapse-specific quality of life was measured using the Pelvic Floor Impact Questionnaire (PFIQ), with lower scores representing improved quality of life (on a scale of 0 to 100). Meta-analysis could not be performed because each trial addressed a different comparison.
Three trials reported data on perceived improvement of prolapse symptoms. At 12 months, compared with PFMT alone, pessary plus PFMT may improve symptoms (absolute risk reduction = 32.4%; 95% CI, 16.3% to 54.6%; NNT = 3; 95% CI, 2 to 6; n = 260; moderate-certainty evidence). Two trials reported data on prolapse-specific quality of life. At 12 months, pessary plus PFMT probably improves prolapse-specific quality of life compared with PFMT alone (median PFIQ interquartile range score was 0.3 in the pessary plus PFMT group vs. 8.9 in the PFMT-only group; P = .02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding (NNH = 27; 95% CI, 5 to 111; n = 260; low-certainty evidence). It is uncertain if pessaries improve pelvic organ prolapse symptoms compared with no treatment or PFMT alone.
The above conclusions should be interpreted with caution because of small sample size. However, they are consistent with guidance from the National Institute for Health and Care Excellence, which supports use of a pessary alone or in conjunction with supervised PFMT for women with symptomatic pelvic organ prolapse.4 The American College of Obstetricians and Gynecologists recommends that symptomatic women be offered a pessary as an alternative to surgery, and that a pessary be considered as part of preconception care for symptomatic women who wish to become pregnant in the future.5 Future high-quality trials should also measure other clinically relevant outcomes, such as perceived resolution of prolapse symptoms, patient-reported satisfaction, or psychological impact.
The practice recommendations in this activity are available at http://www.cochrane.org/CD004010.
Editor's Note: The absolute risk reduction, numbers needed to harm and to treat, and confidence intervals reported in this Cochrane for Clinicians were calculated by the authors based on raw data provided in the original Cochrane review.