Development of a new clamp
Research type
Research Study
Full title
Prostate Cancer UK Continence Management Module 3: Development of an effective and comfortable penile compression device (clamp) Phase 2: Development of a new clamp
IRAS ID
215740
Contact name
M J Fader
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
Prostate Cancer UK Module 3 Phase 2 Development of a new clamp
Long-term urinary incontinence (UI) is a common consequence of treatment for prostate cancer, and between 10-15% of men who have had surgery for prostate cancer will suffer life-long UI requiring the daily use of incontinence products. Incontinence has a major effect on quality of life, leaving men depressed and isolated, affecting personal relationships and resulting in stigma and limited social and professional opportunities. The effective containment of incontinence when treatment fails or is not appropriate is essential. Men have a range of products available to them and often elect to use a mix of two or more products to meet changing needs. Most men use a pad at least some of the time, and a sheath or body-worn urinal for containing leakage over longer periods. The penile clamp (clamp) is a device which men often find useful for short-term and/or vigorous activities e.g. dancing swimming and going for long walks.
In Phase 1 of this study, we established that, although there are many clamps available, when tested by men in the laboratory and in use at home none of them performed well for key criteria of efficacy, user acceptability and physiological impact. We therefore concluded that there is a need for a better clamp which we aim to deliver in Phase 2. A new, improved clamp has the potential to benefit men with UI (usually stress urinary incontinence).
The new clamp will be developed by a research team at the University of Southampton (engineers and clinical specialists) working closely with groups of men some of whom are experienced clamp users who assisted with Phase 1. We plan to use an iterative process to develop a refined prototype which if successful following laboratory and home-based user evaluation, is intended for commercialisation.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0008
Date of REC Opinion
28 Feb 2017
REC opinion
Further Information Favourable Opinion