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Lifestyle advice with or without pelvic floor muscle training for pelvic organ prolapse: a randomized controlled trial

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Abstract

Introduction and hypothesis

We evaluated the effect of adding pelvic floor muscle training (PFMT) to a structured lifestyle advice program.

Methods

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 %.

Results

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.

Conclusion

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.

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Abbreviations

POP:

Pelvic organ prolapse

HRQoL:

Health-related quality of life

POP-Q:

Pelvic Organ Prolapse Quantification system

PFDI-20:

Pelvic Floor Distress Inventory Short Form 20

POPDI-6:

Pelvic Organ Prolapse Distress Inventory-6

CRADI-8:

Colorectal–Anal Distress Inventory-8

UDI-6:

Urinary Distress Inventory-6

PFIQ-7:

Pelvic Floor Impact Questionnaire Short Form-7

UIQ-7:

Urinary Impact Questionnaire-7

CRAIQ-7:

Colorectal–Anal Impact Questionnaire-7

POPIQ-7:

Pelvic Organ Prolapse Impact Questionnaire-7

PISQ-12:

Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12

PGI-I:

Patient Global Index of Improvement Scale

NRS:

Numeric Rating Scale

PFMT:

Pelvic floor muscle training

LG:

Lifestyle advice group

TLG:

Combined pelvic floor muscle training and lifestyle advice group

ITT:

Intention-to-treat analysis

RR:

Relative risk

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Acknowledgments

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

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Herlev Hospital, Herlev Ringvej 75, 2730, Herlev, Copenhagen, Denmark

    Ulla Due & Gunnar Lose

  2. Department of Occupational and Physical therapy, Herlev Hospital, Herlev, Denmark

    Ulla Due

  3. Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark

    Gunnar Lose

  4. Danish Health and Medicines Authority, Division of Hospital Services and Emergency Management, Copenhagen, Denmark

    Søren Brostrøm

Authors
  1. Ulla Due
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  3. Gunnar Lose
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Correspondence to Ulla Due.

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Due, U., Brostrøm, S. & Lose, G. Lifestyle advice with or without pelvic floor muscle training for pelvic organ prolapse: a randomized controlled trial. Int Urogynecol J 27, 555–563 (2016). https://doi.org/10.1007/s00192-015-2852-0

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  • DOI: https://doi.org/10.1007/s00192-015-2852-0

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