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.
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.
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.
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.
International urogynecology journal. 2021 Mar 03 [Epub ahead of print]
Linda McLean, Marylène Charette, Kevin Varette, Kaylee Brooks, Marie-Andrée Harvey, Magali Robert, Kevin Baker, Andrew Day, Vincent Della Zazzera, Eric Sauerbrei, Robert Brison
School of Rehabilitation Sciences, University of Ottawa, 200 Lees Avenue, Room E260C, Ottawa, ON, K1N 6N5, Canada. ., Interdisciplinary School of Health Sciences, University of Ottawa, Ottawa, Canada., School of Rehabilitation Therapy, Queen's University, Kingston, Canada., School of Rehabilitation Sciences, University of Ottawa, 200 Lees Avenue, Room E260C, Ottawa, ON, K1N 6N5, Canada., Department of Obstetrics and Gynaecology, Kingston General Hospital, Kingston, Canada., Department of Obstetrics and Gynaecology, Foothills General Hospital, Calgary, Canada., Department of Obstetrics and Gynaecology, The Ottawa Hospital, Ottawa, Canada., Department of Population Health Sciences, Queen's University, Kingston, Canada., Department of Obstetrics and Gynaecology, Hôpital Montfort, Ottawa, Canada., Department of Radiology, Kingston General Hospital, Kingston, Canada., Department of Emergency Medicine, Kingston General Hospital, Kingston, Canada.