Evaluation of a new disposable “tampon like” electrostimulation technology (Pelviva®) for the treatment of urinary incontinence in women: A 12-week single blind randomized controlled trial§††‡‡

Authors


  • Heinz Koelbl led the peer-review process as the Associate Editor responsible for this paper.

  • Competing Interests: The authors declare J.O. and J.H. have support from Femeda for the submitted work but declare J.O. holds the patent for the electrical stimulation regimen incorporated in the Pelviva® device described in this article. J.O. also received a grant from Femeda the company responsible for developing the device to undertake this research. J.H. is the Clinical Director to Femeda and receives a consultancy fee from the Company.

  • §

    Sponsorship Information and Arrangements: Femeda, the company responsible for developing and producing the Pelviva® device was the trial sponsor. The sponsor was responsible for developing the Pelviva® device, was the funder of the study, and was engaged in the development of the trial design. The sponsor has provided full access to the data and is fully informed of this publication process. The primary author (J.O.) takes full responsibility for the integrity of the data and accuracy of the data analysis.

  • Trial Registration Details: ISRCTN74508432 http://www.controlled-trials.com/ISRCTN74508432 and ISRCTN745084.

  • Independence Statement: This trial was conducted in the Manchester Wellcome Trust Clinical Research Facility. The appointed lead nurse for the study (Ms. Kathryn McBride) was completely independent of the Sponsor and had no conflicting interests. The trial nurses responsible for collating data acted completely independently of the trial sponsor.

  • ††

    Previous Publications: Oldham JA, McBride K, Herbert J. Evaluation of a new electrostim technology for the treatment of urinary incontinence in women: a randomized controlled trial. Neurourology and Urodynamics 2010; 29(6); 1067—abstract presented at ICS/IUGA Conference Canada, August 2010.

  • ‡‡

    Ethical Approval: The study was granted ethical approval by North Sheffield Ethics Committee, January 2009, reference number 06/Q2308/134. MHRA approval was also granted in 2009, reference number CI/2009/0008.

    What this paper adds:

     • Evaluation of a completely new disposable “tampon like” home use electrostimulation device for the treatment of urinary incontinence.

    What is known on this subject:

     • Electrostimulation is usually therapist led.

     • Pelvic floor muscle exercise may be difficult to perform.

     • 50% of women don't seek help for their incontinence.

    There is a place for a new electrostimulation device that enables women to treat themselves in their own home.

Abstract

Aims

To test the null hypothesis that a novel disposable “tampon like” electrostimulation device (Pelviva®) is no better than unsupervised pelvic floor muscle exercise for treatment of urinary incontinence in women.

Methods

Pre/post-intervention assessor blinded, single center RCT. A total of 123 community dwelling self referred women with symptoms of stress, urge, or mixed incontinence were randomly assigned to one of two 12-week duration treatments: Pelviva® used for 30 min a day plus unsupervised pelvic floor muscle exercise or unsupervised exercises alone. Outcome measures included ICIQ-UI (primary), ICIQ FLUTSex and global impression of severity and improvement (secondary) completed at recruitment, after 4 weeks of unsupervised exercise and immediately post-treatment. Diary of exercise frequency/type, overall impression, and usage of device was completed mid- and post-treatment.

Results

Pelviva® plus exercise produced significantly better outcome than unsupervised exercise alone: 5 points (45%) versus 1 point (10%) for ICIQ-UI (P = 0.014); 67% versus 33% for leak frequency (P = 0.005); 40% versus 20% for leak interference with life (P = 0.018). Incontinence was less bothersome during sex to a greater extent in the Pelviva® group (P = 0.026). Women were enthusiastic about the device, found it comfortable/easy to use and experienced no adverse events.

Conclusions

The Pelviva® device plus unsupervised exercise is more successful than unsupervised pelvic floor muscle exercise alone in treating urinary incontinence. The device is easy/comfortable to use, there are no apparent adverse incidents, and women can manage their incontinence in the privacy of their own home. The product will be launched 2013. Neurourol. Urodynam. 32: 460–466, 2013. © 2012 Wiley Periodicals, Inc.

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