Pessary not ‘noninferior’ to surgery for subjective improvement of pelvic organ prolapse

Patient-reported improvement of pelvic organ prolapse symptoms was similar for pessary vs. surgery, but ultimately did not meet the noninferiority endpoint in a 2-year randomized clinical trial, according to data published in JAMA.

These findings differ from 1-year interim results presented at the American Urogynecologic Society and International Urogynecological Association Scientific Meeting in June, which showed pessary yielded greater subjective improvement and sexual well-being vs. surgery.

“Pessary therapy and surgery are both effective treatment options for pelvic organ prolapse,” Lisa R. van der Vaart, MD, a PhD candidate at Amsterdam University Medical Center, and colleagues wrote. “Two systematic reviews and the guideline from the National Institute for Health and Clinical Excellence on the management of pelvic organ prolapse urge the need for randomized clinical trials with long-term follow-up to generate evidence about patient satisfaction following surgery and with pessary therapy for pelvic organ prolapse. Such trials would optimize treatment selection and facilitate counseling of patients with symptomatic pelvic organ prolapse.”

From March 2015 to November 2019, van der Vaart and colleagues recruited 440 women from 21 hospitals in the Netherlands who had symptomatic stage 2 or greater pelvic organ prolapse. Participants were randomly assigned to pessary therapy (n = 218) or surgery (n = 222).

Subjective improvement was self-reported using the Patient Global Impression of Improvement, which included one question about perceived improvement with answers ranging from “very much better” to “very much worse” on a seven-point scale. Improvement was defined as responses of “much better” and “very much better.”

To determine noninferiority of pessary therapy vs. surgery, a 10-percentage point risk difference margin was set.

In total, 173 (79.3%) women assigned to the pessary group and 162 (73.3%) women assigned to the surgery group completed follow-up at 2 years. Of these, 132 (76.3%) and 132 (81.5%) women, respectively, reported subjective improvement. The risk difference was –6.1%, which did not meet the set noninferiority margin.

In the per-protocol analysis, 52 (70.3%) of 74 women in the pessary group and 125 (83.3%) of 150 women in the surgery group reported improvement (risk difference, –13.1%). However, the risk difference did not meet the noninferiority margin.

The most common adverse events were discomfort reported by 42.7% of the pessary group and postoperative urinary tract infection for 9% of the surgery group.

Of note, 118 (54.1%) women from the pessary group switched to surgical treatment, most commonly because of pessary expulsion (n = 38; 32.2%).

“Interpretation is limited by loss to follow-up and the large amount of participant crossover from pessary therapy to surgery,” van der Vaart and colleagues wrote.