Vibrance Pelvic Trainer Clinical Study Findings

Objective

A randomized control trial to compare the effectiveness of pelvic floor exercises with the Vibrance Pelvic Trainer compared to standard Kegel pelvic floor exercises for the treatment of stress urinary incontinence in females.

The clinical study was conducted in University Malay Medical Center by the Urology Unit under the Department of Surgery, Department of Obstetric and Gynecology and the Department of Physiotherapy. The aim of the study was to compare the effect of pelvic floor muscle exercises with the VPT vs pelvic floor muscle exercises using standard Kegel techniques alone in women with stress urinary incontinence.

Methodology

A randomized controlled trial of 40 adult female participants with stress urinary incontinence symptoms was carried out from October 2011 to October 2013. Subjects were randomly assigned to pelvic floor exercise (PFME)(n=20) and PFME with VPT (n=20). The VPT is an intravaginal pelvic floor exercise device that gives a positive biofeedback to the patient via vibration, that can only be triggered by squeezing the pelvic floor muscles. Patients were assessed by validated female pelvic floor questionnaires (validated by Baessler K) and Modified Oxford Scales at 0, 1 and 4 months post randomization.

Results

• VPT showed significantly earlier improvement in SUI and is effective in reducing urine leakage.
• At 4 weeks, SUI score significantly reduced in 38.5% of patients in VPT group vs Control Group at 18.6%.
• VPT increases pelvic floor muscle strength significantly as compared to control group using only traditional supervised pelvic floor exercise training by physiotherapists.

Comparison of average urinary symptom score

• At 4 weeks, 4 patients from VPT group showed improvement in Pelvic Muscle Strength vs none from control group.
• At 16 week, 14 patients from VPT group showed significant improvement in Pelvic Muscle Strength vs 4 in control group.

Comparison of average impact on social life

Comparison of average bothersome score

Comparison of average pad usage score