The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an investigator-blinded parallel randomized clinical trial
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Introduction and hypothesis
Urinary incontinence is a prevalent problem in women with spinal cord injury. The aim of this study was to examine the effect of pelvic floor muscle training (PFMT) alone and combined with intravaginal electrical stimulation (IVES) on urinary incontinence in women with incomplete spinal cord injury.
In this investigator-blinded randomized clinical trial, we recruited women aged 18–75 with incomplete spinal cord injury and urinary incontinence from a single spinal cord injury clinic in Denmark. Women were randomly assigned to either PFMT or PFMT combined with IVES daily at home for 12 weeks. All women were trained by a physiotherapist using vaginal palpation and electromyography biofeedback. Outcome measures were recorded at baseline (week 0), post-intervention (week 12) and follow-up (week 24) and included change in the total score on the International Consultation on Incontinence Questionnaire urinary incontinence short form (ICIQ-UI-SF) and daily episodes of urinary incontinence.
From 27 April 2015−9 September 2016, we randomly assigned 36 women (17 in the PFMT group and 19 in the PFMT+IVES group); 27 completed the interventions (13 in the PFMT group and 14 in the PFMT+IVES group). The results showed no difference between the groups on ICIQ-UI-SF or episodes of urinary incontinence at 12 and 24 weeks. Only the PFMT group had a significant change from baseline on ICIQ-UI-SF [−2.4 (95% CI -4.3−−0.5), p = 0.018] and daily episodes of urinary incontinence [−0.4 (95% CI -0.8−−0.1), p = 0.026] at 12 weeks.
PFMT+IVES is not superior to PFMT alone in reducing urinary incontinence in women with incomplete spinal cord injury.
KeywordsUrinary incontinence Spinal cord injury Pelvic floor muscle training Electrical stimulation Neurogenic bladder
The authors thank Berit Sejersen Larsen from the Department of Obstetrics and Gynecology, Herlev and Gentofte Hospital, for her practical assistance during the project and Birthe Pedersen from the Clinic for Spinal Cord Injuries, Rigshospitalet, Tanja Skarum and Malene Skov Mailand from the Department of Occupational and Physical Therapy, Herlev and Gentofte Hospital, for their assistance with the physical therapy consultations.
This study was funded by the Grosserer L.F. Foghts Fond (grant no. 20.941), Aase og Ejnar Danielsens Fond (grant no. 10–001425) and Nordic Urogynecological Association. Marlene Elmelund and Niels Klarskov have received personal fees from Astellas Pharma outside the submitted work.
Compliance with ethical standards
M. Elmelund: Astellas Pharma. Paid travel expenses and honaria.
N. Klarskov: Astellas Pharma. Paid travel expenses and honaria, acceptance of payment for research.
U. Due: None.
F. Biering-Sørensen: None.
Conflicts of interest
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