Pessary Versus Surgery: 4 PEOPLE Trial Checks

England’s NICE¹ guideline considers a vaginal pessary for symptomatic prolapse, alone or alongside supervised pelvic floor training. It offers surgery when symptoms have not improved with nonsurgical treatment or when a woman declines that treatment. The choice includes preferences, health and the risks of individual procedures.¹

Who participated?

PEOPLE randomized 440 women with symptomatic stage 2-or-higher prolapse after successful pessary fitting. Prior pessary use or prolapse/incontinence surgery excluded participation. One surgery-arm participant was excluded. Mean age: 64.7 years.²

Ask the clinician to name the prolapse site and stage, then explain whether both options suit your circumstances. A previous operation belongs in that conversation. For practical fitting questions, see our pessary appointment guide.

What counted?

At 24 months, 132/173 assigned pessary treatment and 132/162 assigned surgery reported much or very much improvement: 76.3% versus 81.5%. This measured perceived improvement, not anatomical cure.²

Write down what you want treatment to change: a bulge that rubs during a walk, pressure after standing, or difficulty emptying. Bring that list to the appointment and ask how each symptom will be assessed.

Was noninferiority established?

No. The trial could not rule out pessary outcomes more than 10 percentage points worse (one-sided 95% lower bound: −12.7). Both as-randomized and per-protocol analyses (52/74 versus 125/150 responders) failed. This does not establish surgical superiority.²

173/218 and 162/221 provided 24-month outcomes.²

Ask for the expected results of the particular operation being proposed, its recovery period and what happens if prolapse returns. NICE¹ recommends discussing recurrence, urinary, bowel and sexual effects, and uncertainty about long-term complications.¹

Who switched treatments?

Among women assigned pessary treatment, 118/218 switched to surgery. This compared initial strategies, not uninterrupted pessary use. Discomfort affected 93/218 pessary users; postoperative urinary infection affected 20/221.²

ZonMW funded the trial; an author disclosed outside fees from Coloplast and Promedon.²

Before choosing a pessary, agree who will remove it, how to report discomfort and what would prompt a refitting or another treatment discussion. NICE¹ says several fittings may be necessary and recommends discussing discharge, bleeding, expulsion and the effect of different devices on intercourse. It advises removal at least every six months to prevent serious complications, with six-monthly clinic appointments for women at risk who may struggle with care. Ask for instructions for your device; that minimum is not a cleaning schedule for every pessary.¹

Bring these questions to the decision visit: “If a pessary does not relieve my bulge symptoms, can we try another fit? Which operation would you consider next, and how would its risks and recovery affect my work and caring responsibilities?”

Laugh, Sneeze, Jump includes “What to Say in the Room,” with prompts about treatment goals, expected timing, common and serious risks, and follow-up. Use those appointment questions alongside the prolapse-specific discussion; its fitted-pessary evidence concerns stress incontinence.