Prostate Cancer UK Module 3 Phase 1: Evaluation of existing clamps
Research type
Research Study
Full title
Prostate Cancer UK Module 3: Development of an effective and comfortable penile compression device (clamp) Phase 1: Evaluation of existing clamps
IRAS ID
145784
Contact name
M J Fader
Contact email
Research summary
Long-term urinary incontinence (bladder leakage) 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 urinary incontinence. Initially most men will use absorbent products (pads).However, recent research indicates that men appreciate being able to choose from a selection of devices and pads to fully meet their lifestyle needs. Clamps (or penile compression devices)are more secure, less likely to leak and allow greater clothing choice than other devices and pads. They are particularly useful for short energetic activities (such as exercise or dancing)but the drawback of existing clamps is that they can be significantly more painful then other products.
Study aims:
a. To review all existing clamps and to compare the performance of a maximum of five clamps for use by men with long-term (over 12 months) urinary incontinence following treatment for prostate cancer.
b. To identify the strengths and limitations of a selection of available clamps.
c. To investigate which of the clamps are most effective at preventing/reducing urinary incontinence.
d. To investigate the effect of wearing a clamp on penile blood flow and skin health.
If through this study we are unable to identify a clamp which is safe to use, effective at preventing urine leakage and acceptable to men, we will continue to a second (already funded) study in which we plan to either modify an existing clamp or develop a new clamp.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1034
Date of REC Opinion
4 Aug 2014
REC opinion
Further Information Favourable Opinion