title: A pilot randomised controlled trial of the pelvic toner device in female stress urinary incontinence.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Musculoskeletal Research Unit, Avon Orthopaedic Centre, Southmead Hospital, Bristol, BS10 5NB, UK.
authors: Debbie
authors: D
authors: Delgado
authors: Paul
authors: P
authors: White
authors: Ruben
authors: R
authors: Trochez
authors: Marcus J
authors: MJ
authors: Drake
mesh_terms: D000328:Adult; D000368:Aged; D004864:Equipment and Supplies; D005240:Feasibility Studies; D005246:Feedback; D005260:Female; D006801:Humans; D008875:Middle Aged; D053580:Muscle Strength / Q000502:physiology*; D017063:Outcome Assessment, Health Care; D017773:Pelvic Floor / Q000502:physiology*; D010865:Pilot Projects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000628:therapy*
references: Cochrane Database Syst Rev. 2013 Jul 08;(7):CD002114
references: 23836411
references: Curr Opin Urol. 2009 Jul;19(4):337-41
references: 19444118
references: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD005654
references: 20091581
references: Obstet Gynecol. 1990 Apr;75(4):671-5
references: 2314786
references: Am J Obstet Gynecol. 1948 Aug;56(2):238-48
references: 18877152
references: Cochrane Database Syst Rev. 2011 Jul 06;(7):CD009252
references: 21735442