Lifestyle advice with or without pelvic floor muscle training for pelvic organ prolapse: a randomized controlled trial
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Introduction and hypothesis
We evaluated the effect of adding pelvic floor muscle training (PFMT) to a structured lifestyle advice program.
This was a single-blinded randomized trial of women with symptomatic pelvic organ prolapse (POP) stage ≥ II. Participants were randomized to a structured lifestyle advice program with or without PFMT. Both groups received similar lifestyle advice in six separate group sessions. The combined group performed group PFMT after an individual assessment. Primary outcome was a global improvement scale at six-month follow-up. Secondary outcomes were the global scale and objective POP at three-month follow-up, symptoms and quality of life including sexuality, at three and six-month follow-up. A clinically relevant change of symptoms was defined as ≥15 %.
We included 109 women. Eighty-nine women (82 %) completed three months follow-up; 85 (78 %) completed six-month follow-up. At both follow-ups, significantly more women in the combined group reported improvement in the global scale. At the three-month follow-up, the combined group only had significant improvement of POP symptoms while only the lifestyle advice group had significant improvement of quality of life. Change in objective POP and sexuality was nonsignificant. The symptom score improved 17 % in the combined group and 14 % in the lifestyle advice group (P = 0.57). Significantly more women in the lifestyle advice group had sought further treatment at the six-month follow-up.
Adding PFMT to a structured lifestyle advice program gave superior results in a global scale and for POP symptoms. Overall effect of either intervention barely reached clinical relevance.
KeywordsConservative treatment Lifestyle advice Pelvic floor muscle training Pelvic organ prolapse
Pelvic organ prolapse
Health-related quality of life
Pelvic Organ Prolapse Quantification system
Pelvic Floor Distress Inventory Short Form 20
Pelvic Organ Prolapse Distress Inventory-6
Colorectal–Anal Distress Inventory-8
Urinary Distress Inventory-6
Pelvic Floor Impact Questionnaire Short Form-7
Urinary Impact Questionnaire-7
Colorectal–Anal Impact Questionnaire-7
Pelvic Organ Prolapse Impact Questionnaire-7
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12
Patient Global Index of Improvement Scale
Numeric Rating Scale
Pelvic floor muscle training
Lifestyle advice group
Combined pelvic floor muscle training and lifestyle advice group
We thank physical therapists Dorthe Svarre Petersen, Katrin Jacobæus, Therese Simonsen, Annette Sørensen, and Marie Thorsager for their help with the two interventions; Tobias Wirenfeldt Clausen, statistician at the Department of Hematology, Herlev Hospital for help with statistical analyses; research nurse Berit Sejersen Larsen, Department of Gynecology and Obstetrics, Herlev Hospital, for her tremendous work with the randomization and follow-up of participants; the Department of Physical therapy, Herlev Hospital, for allowing us to use all their facilities.
Conflicts of interest
Ulla Due has been paid as a consultant for Astellas Pharma, Coloplast, and SCA and was partly funded with a research grant from the Association of Danish Physiotherapists; the funding source had no involvement in the study
Søren Brostrøm has no financial disclosures
Gunnar Lose has received grants from Astellas Pharma and Coloplast, and has been paid as consultant for Contura
Preliminary data from this paper was presented at the 29th Biannual Meeting of the Nordic Urogynaecological Association (NUGA) in Stockholm, Sweden, 29–31 January 2015 Ulla Due
The study was approved by the Danish Scientific Ethical Committee (H-4-2011-072) 24 August 2011
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