Therapeutics Randomised controlled trial
Individualised pelvic floor muscle training is an effective conservative treatment in women with pelvic organ prolapse 10.1136/ebmed-2014-110020
S Abbas Shobeiri, Andrea C Santiago Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA Correspondence to: Dr S Abbas Shobeiri, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, 920 Stanton L. Young Boulevard, PO Box 26901, WP 2410, Oklahoma City, OK 73190, USA; [email protected]
Commentary on: Hagen S, Stark D, Glazener C, et al. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. Lancet 2014;383:796–806.
Context In the USA alone the number of pelvic organ prolapse (POP) cases is expected to increase substantially, from 3.3 m in 2010 to 4.9 m in 2050.1 At least 200 000 operations are performed annually in the USA with surgical failures reportedly occurring in up to 58% of cases, with about one-third of women undergoing more than one surgery for prolapse recurrence.2 3 A few studies have, with mixed results, investigated the role of pelvic floor muscle training (PFMT) in addressing POP.4 This study aimed to assess whether one-to-one PFMT would reduce symptoms and further treatment need in women with stages I-III POP, and whether it would be cost-effective compared with a prolapse lifestyle advice leaflet.
Methods This was a parallel group, randomised controlled trial involving 23 centres. Women with newly diagnosed symptomatic stage I, II or III prolapse were assigned to receive an individualised PFMT programme or a prolapse lifestyle advice leaflet and no muscle training (control group). The primary outcome was self-report of symptoms at 12 months using the Pelvic Organ Prolapse Symptom Score (POP-SS), a validated questionnaire with seven items relating to symptom frequency in the previous 4 weeks. Intention-to-treat analysis was used to compare the primary outcome at 12 months. The report clearly stated patient selection criteria, randomisation and masking procedures, and acknowledged that the intervention was carried out based on a pilot study.5 The main results were presented as the between-group difference in estimated mean change from baseline for 6 and 12 months.
Findings Of 447 patients, 225 were randomised to intervention and 222 to control. Eighty-four per cent (n=377) completed follow-up at 6 months and 66% (n=295) at 12 months. Women in the intervention group reported fewer symptoms at 12 months (mean POP-SS reduction = 3.77 (SD=5.62) vs 2.09 (SD=5.39); adjusted difference = 1.52, 95% CI 0.46 to 2.59; p=0.0053). Also, more women in the control group received further treatment (risk ratio = 2.1, 1.5 to 2.9, p
Individualised pelvic floor muscle training is an effective conservative treatment in women with pelvic organ prolapse 10.1136/ebmed-2014-110020
S Abbas Shobeiri, Andrea C Santiago Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA Correspondence to: Dr S Abbas Shobeiri, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, 920 Stanton L. Young Boulevard, PO Box 26901, WP 2410, Oklahoma City, OK 73190, USA; [email protected]
Commentary on: Hagen S, Stark D, Glazener C, et al. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. Lancet 2014;383:796–806.
Context In the USA alone the number of pelvic organ prolapse (POP) cases is expected to increase substantially, from 3.3 m in 2010 to 4.9 m in 2050.1 At least 200 000 operations are performed annually in the USA with surgical failures reportedly occurring in up to 58% of cases, with about one-third of women undergoing more than one surgery for prolapse recurrence.2 3 A few studies have, with mixed results, investigated the role of pelvic floor muscle training (PFMT) in addressing POP.4 This study aimed to assess whether one-to-one PFMT would reduce symptoms and further treatment need in women with stages I-III POP, and whether it would be cost-effective compared with a prolapse lifestyle advice leaflet.
Methods This was a parallel group, randomised controlled trial involving 23 centres. Women with newly diagnosed symptomatic stage I, II or III prolapse were assigned to receive an individualised PFMT programme or a prolapse lifestyle advice leaflet and no muscle training (control group). The primary outcome was self-report of symptoms at 12 months using the Pelvic Organ Prolapse Symptom Score (POP-SS), a validated questionnaire with seven items relating to symptom frequency in the previous 4 weeks. Intention-to-treat analysis was used to compare the primary outcome at 12 months. The report clearly stated patient selection criteria, randomisation and masking procedures, and acknowledged that the intervention was carried out based on a pilot study.5 The main results were presented as the between-group difference in estimated mean change from baseline for 6 and 12 months.
Findings Of 447 patients, 225 were randomised to intervention and 222 to control. Eighty-four per cent (n=377) completed follow-up at 6 months and 66% (n=295) at 12 months. Women in the intervention group reported fewer symptoms at 12 months (mean POP-SS reduction = 3.77 (SD=5.62) vs 2.09 (SD=5.39); adjusted difference = 1.52, 95% CI 0.46 to 2.59; p=0.0053). Also, more women in the control group received further treatment (risk ratio = 2.1, 1.5 to 2.9, p
