PESSRI: Ring-with-Support versus Gellhorn Pessaries for Pelvic Organ Prolapse
PESSRI was a multicenter randomized crossover trial in 134 women with symptomatic pelvic organ prolapse comparing a ring with support versus a Gellhorn pessary for three months each; both improved symptom distress and life impact, with no clinically significant between-device difference in the reported scales.[1]
- Design and population
- Multicenter randomized crossover comparison. 134 women with symptomatic pelvic organ prolapse of POP-Q stage II or greater, with median stage III.
- Arms
- Ring-with-support pessary versus Gellhorn pessary
- Report and follow-up
- 2007 · Three months with each assigned pessary
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| PFDI scales at three months or earlier if pessary use stopped | Statistically and clinically significant improvement on most scales vs Statistically and clinically significant improvement on most scales | — | |
| PFIQ scales at three months or earlier if pessary use stopped | Statistically and clinically significant improvement on many scales vs Statistically and clinically significant improvement on many scales | — |
Registry not recorded · Report DOI
Design
Eligible women had POP-Q stage II or greater prolapse; the median stage was III. The initial randomized sequence assigned 71 women to the ring and 63 to the Gellhorn. Participants then crossed to the other device. The investigators assessed satisfaction on a visual analog scale and symptom distress and life impact with the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ).[1]
Results
After each device period, most PFDI scales and many PFIQ scales showed statistically and clinically significant improvement from baseline with both pessaries. The authors reported no clinically significant between-device difference in these measures. Their conclusion specifically names relief of protrusion and voiding dysfunction.[1]
Surgery and treatment delivery
Three-month outcome data were available for 94 ring periods and 99 Gellhorn periods. These are device-period observations in a crossover study.[1]
Adverse events
The reported symptom and life-impact outcomes do not quantify device-specific complications.[1]
Limitations
The comparison measured short-term patient-reported symptoms and life impact. Outcome capture was incomplete relative to enrollment, which matters for a paired crossover analysis.[1]
In conversation
Same setting TOPSY (2023)
Guidelines and approvals
ACOG/AUGS (Practice Bulletin 214, 2019). Women considering treatment for pelvic organ prolapse should be offered a vaginal pessary as an alternative to surgery . The bulletin cites PESSRI when discussing pessary effectiveness.[2]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2007 | Initial crossover report · primary | — | PFDI scales at three months or earlier if pessary use stopped: Statistically and clinically significant improvement on most scales vs Statistically and clinically significant improvement on most scales; — PFIQ scales at three months or earlier if pessary use stopped: Statistically and clinically significant improvement on many scales vs Statistically and clinically significant improvement on many scales; — | Cundiff GW, Amundsen CL, Bent AE, et al. "The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries." *Am J Obstet Gynecol.* 2007;196(4):405.e1-405.e8. doi:10.1016/j.ajog.2007.02.018 DOI |
References
1. Cundiff GW, Amundsen CL, Bent AE, et al. "The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries." Am J Obstet Gynecol. 2007;196(4):405.e1-405.e8. doi:10.1016/j.ajog.2007.02.018
2. American College of Obstetricians and Gynecologists, American Urogynecologic Society. "Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214." Obstet Gynecol. 2019;134(5):e126-e142. doi:10.1097/AOG.0000000000003519