Heinz Koelbl led the peer-review process as the Associate Editor responsible for this paper.
Original Clinical Article
Article first published online: 28 SEP 2012
Copyright © 2012 Wiley Periodicals, Inc.
Neurourology and Urodynamics
Volume 32, Issue 5, pages 460–466, June 2013
How to Cite
Oldham, J., Herbert, J. and McBride, K. (2013), 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. Neurourol. Urodyn., 32: 460–466. doi: 10.1002/nau.22326
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.
- Issue published online: 18 JUN 2013
- Article first published online: 28 SEP 2012
- Manuscript Accepted: 31 AUG 2012
- Manuscript Received: 14 JUN 2012
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