Pessary therapy fails to match up with surgery in women with symptomatic pelvic organ prolapse
Netherlands: A new research found that pessary therapy could not meet the required criteria for patient-reported improvement at 24 months when compared to surgery in patients with pelvic organ prolapse. The trial results were published in the journal JAMA Network.
Pelvic organ prolapse is a prevalent condition among women that causes bothersome vaginal bulge symptoms as well as urinary, bowel, or sexual dysfunction thus negatively affecting their quality of life. There is a global need for cost-effective care for women with pelvic organ prolapse with increased life expectancy. Previous literature suggested pessary management and surgery as options for the management of pelvic organ prolapse, but recent data showed that women reported subjective improvement following surgery as compared with pessary therapy. Hence Lisa R. van der Vaart et al from the Netherlands conducted a randomized controlled trial to investigate if pessary treatment is non-inferior to surgery among patients with symptomatic pelvic organ prolapse from March 2015 through November 2019 and followed up till June 2022.
A noninferiority randomized clinical trial called the PEOPLE project was conducted in 21 participating hospitals in the Netherlands. Women with symptomatic stage 2 or greater pelvic organ prolapse were enrolled in the study. Out of 1605 women, 440 gave informed consent. Participants were with a mean [SD] age of 64.7 [9.29] years and were randomized to two groups to receive pessary treatment (218 participants) and 222 to surgery.
The primary outcome was subjective patient-reported improvement at 24 months. It was measured with the Patient Global Impression of Improvement scale, a 7-point Likert scale ranging from very much better to very much worse. This scale was dichotomized as successful, defined as much better or very much better, vs Nonsuccessful treatment. The noninferiority margin was set at 10 percentage points risk difference. Data on the crossover between therapies and adverse events were captured.
Findings of the trial:
- Out of 440 participants, 173 (79.3%) in the pessary group and 162 (73.3%) in the surgery group completed the trial at 24 months.
- Subjective improvement was reported by 132 of 173 (76.3%) in the pessary group vs 132 of 162 (81.5%) in the surgery group in the population that was analyzed as randomized.
- A similar result was seen for subjective improvement with 52 of 74 (70.3%) in the pessary group vs 125 of 150 (83.3%) in the surgery group as per the per-protocol analysis.
- Nearly 118 out of 218 (54.1% participants) showed a crossover from pessary to surgery.
- The most common adverse event among pessary users was discomfort (42.7%) while in the surgery group it was urinary tract infection (9%).
Thus, symptomatic pelvic organ prolapse patients did not benefit from pessary treatment when compared to surgery as there was no patient-reported improvement and the crossover from pessary to surgery was also high.
Further reading: van der Vaart LR, Vollebregt A, Milani AL, et al. Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse: A Randomized Clinical Trial. JAMA. 2022;328(23):2312–2323. doi: 10.1001/jama.2022.22385
