Effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training in older women with pelvic organ prolapse: 2-year follow-up of a randomized controlled trial in primary care

Objective: We investigated the effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training (PFMT) in women with pelvic organ prolapse over a 2-year period. Methods: Randomized controlled trial with women (>= 55 y) with symptomatic pelvic organ prolapse, identified by screening. Participants were recruited from 20 primary care practices (October 2009-December 2012). Primary outcome was the difference in change of pelvic floor symptoms (PFDI-20 score) between groups over 24 months. Secondary outcomes included prolapse, urinary, and anorectal symptoms; quality of life; costs; sexual functioning; prolapse stage; pelvic floor muscle function; and participants' perceived symptom improvement. Results: There was a nonsignificant difference in the primary outcome between pessary treatment (n = 82) and PFMT (n = 80) with a mean difference of -3.7 points (95% CI, -12.8 to 5.3; P = 0.42) in favor of pessary treatment. A significantly greater improvement in the prolapse symptom score was, however, seen with pessary treatment (mean difference -3.2 points [95% CI, -6.3 to -0.0; P = 0.05]). Direct medical costs over the 2-year study were $309 and $437 per person for pessary treatment and PFMT, respectively. Conclusions: In older women with symptomatic prolapse, there was no significant difference between pessary treatment and PFMT in reducing pelvic floor symptoms, but specific prolapse-related symptoms did improve more with pessary treatment. Pessary treatment was preferable in the cost-effectiveness analysis. When counseling women for prolapse treatment it should, however, be taken into account that pessary fitting fails in a considerable portion of women and that pessary treatment was associated with more side effects compared with PFMT.