A pilot randomised controlled trial of the pelvic toner device in female stress urinary incontinence

Abstract

To determine the feasibility of using the pelvic toner device (PTD) in aiding pelvic floor muscle training (PFMT) METHODS: Forty women, aged at least 18 years with symptoms of pure stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence were randomly assigned to standard PFMT (ST group), or to PFMT and additional PTD (PTD group). They were evaluated throughout a treatment period of 16 weeks, and followed up 6 months after the active treatment period, using International Consultation on Incontinence Questionnaires (ICIQ), bladder diaries, and other subjective outcome measures for symptom improvement. Twenty-four women were randomised to ST and 28 to PTD. Twelve women did not complete therapy and analysis was performed on 19 randomised to ST and 21 randomised to PTD on a per protocol basis. The two groups showed statistically significant symptom improvement in ICIQ responses, both at 16 weeks and at 6 months. There was no significant difference between the groups regarding improvement in SUI (ST 52.6%, PTD 52.4%) at 16 weeks. At 6 months after the active treatment period, 60% of women (50%, 8 in the PTD group and 71.4 %, 10 in the ST group) were still doing pelvic floor exercises. The sample difference observed was not statistically significant. Some women reported that the device helped with confidence that the correct muscles were being contracted, and helped motivation to sustain PFMT. This pilot study demonstrates the feasibility of PTD for aiding PFMT. It is a safe and well-tolerated adjunct in PFMT, which increases patient choice.