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Pelvic floor muscle training as an adjunct to a midurethral sling: a single-blind randomised controlled trial

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Abstract

Introduction and hypothesis

This single-blind, randomised controlled trial was aimed at determining whether peri-operative physiotherapist-supervised pelvic floor muscle (PFM) training was superior to standard care (handout) in terms of improvements in stress urinary incontinence (SUI) symptoms, cure rate, and/or post-operative filling or voiding symptoms among women undergoing surgical mid-urethral sling (MUS) insertion for SUI.

Methods

Women with SUI were recruited from surgical wait lists at four participating urogynecology clinics. Participants were assessed at baseline (V1) then randomised (1:1 allocation) to receive supervised PFM training or a handout. Immediately following the 12-week intervention period (V2) and at 12 weeks following surgery (V3) the groups were compared based on the Female Lower Urinary Tract Symptoms (FLUTS) questionnaire total score and urinary incontinence, filling, and voiding subscale scores as well as on a standardised 30-min pad test administered by a blinded assessor. Intention-to-treat analyses were performed.

Results

A total of 52 participants were randomised to physiotherapy and 51 to the control group between December 2012 and August 2016. The groups were not different on any outcomes at V1 and all were improved at V3 compared with V1 (p < 0.001). At V3 the physiotherapy group reported significantly fewer UI symptoms (FLUTS UI subscale score) than the control group; yet, there were no group differences in FLUTS overall score or the pad test (p > 0.05). Based on a FLUTS UI subscale score <4, the cure rate at V3 was higher in the intervention group (73%) than in the control group (47%); (2.36 < OR < 3.47, p = 0.012). There were no group differences in cure rate at V3 based on a pad test (p = 0.27). No group differences were found in the filling or voiding symptoms at V3 (p > 0.05). No adverse events were reported.

Conclusion

Physiotherapist-supervised PFM training improves SUI cure rates associated with surgical MUS insertion when considering symptoms of SUI, but does not improve post-operative continence function as measured by a pad test, nor does it lead to fewer post-operative voiding or filling symptoms.

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Notes

  1. The ICIQ-qol questionnaire noted in the registered protocol was replaced by the SF-36 questionnaire with a view to performing an economic analysis if deemed appropriate.

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Acknowledgement

The authors would like to acknowledge the participation of EFW Radiology Calgary for providing access to an ultrasound system and an assessment space for data collection.

Funding

Dr. Brison reports grants from the Canadian Institutes of Health Research during the conduct of the study; Dr. McLean reports grants from the Canadian Institutes of Health Research (#111168), grants from the Natural Sciences and Engineering Council of Canada during the conduct of the study; no restrictions were place on publication.

Author information

Authors and Affiliations

  1. School of Rehabilitation Sciences, University of Ottawa, 200 Lees Avenue, Room E260C, Ottawa, ON, K1N 6N5, Canada

    Linda McLean & Kaylee Brooks

  2. School of Rehabilitation Therapy, Queen’s University, Kingston, Canada

    Linda McLean & Kevin Varette

  3. Interdisciplinary School of Health Sciences, University of Ottawa, Ottawa, Canada

    Marylène Charette

  4. Department of Obstetrics and Gynaecology, Kingston General Hospital, Kingston, Canada

    Marie-Andrée Harvey

  5. Department of Obstetrics and Gynaecology, Foothills General Hospital, Calgary, Canada

    Magali Robert

  6. Department of Obstetrics and Gynaecology, The Ottawa Hospital, Ottawa, Canada

    Kevin Baker

  7. Department of Population Health Sciences, Queen’s University, Kingston, Canada

    Andrew Day

  8. Department of Obstetrics and Gynaecology, Hôpital Montfort, Ottawa, Canada

    Vincent Della Zazzera

  9. Department of Radiology, Kingston General Hospital, Kingston, Canada

    Eric Sauerbrei

  10. Department of Emergency Medicine, Kingston General Hospital, Kingston, Canada

    Robert Brison

Authors
  1. Linda McLean
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  2. Marylène Charette
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  11. Robert Brison
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Contributions

L. McLean: protocol/project development, data analysis, manuscript writing/editing; M. Charette: manuscript writing/editing; K. Varette: data collection, manuscript editing; K. Brooks: data collection, manuscript editing; M.A. Harvey: physician partner, manuscript editing; M. Robert: data collection, physician partner, manuscript editing; K. Baker: physician partner, manuscript editing; A. Day: data analysis, manuscript editing; V. Della Zazzera: physician partner, manuscript editing; E. Sauerbrei: physician partner, manuscript editing; R. Brison: physician partner, manuscript editing.

Corresponding author

Correspondence to Linda McLean.

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Clinical trial registration: NCT01602107

Study conducted in Ottawa and Kingston, Ontario, Canada

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McLean, L., Charette, M., Varette, K. et al. Pelvic floor muscle training as an adjunct to a midurethral sling: a single-blind randomised controlled trial. Int Urogynecol J 33, 809–819 (2022). https://doi.org/10.1007/s00192-020-04668-9

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  • DOI: https://doi.org/10.1007/s00192-020-04668-9

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