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The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries |
Cundiff GW, Amundsen CL, Bent AE, Coates KW, Schaffer JI, Strohbehn K, Handa VL |
American Journal of Obstetrics and Gynecology 2007 Apr;196(4):405.e401-405.e408 |
clinical trial |
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: The aim of this randomized crossover trial was to compare symptom relief and change in life impact for women using the ring with support and Gellhorn pessaries. STUDY DESIGN: Subjects were randomized to use each pessary for 3 months. Outcome data included a visual analog satisfaction score, and quality of life questionnaires. Analysis included student's t-test, Wilcoxan Signed-rank test and logistical regression. RESULTS: Subjects were primarily white, parous, postmenopausal women with a mean age of 61. The median POPQ stage was III. We enrolled 134 subjects and collected 3-month data on 94 ring and 99 Gellhorn subjects. There were statistically and clinically significant improvements in the majority of the PFDI and many PFIQ scales with both pessaries, but no clinically significant differences between the two pessaries. CONCLUSIONS: The ring with support and Gellhorn pessaries are effective and equivalent in relieving symptoms of protrusion and voiding dysfunction.
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