Hypothesis / aims of study
Urinary incontinence (UI) occurs after radical prostatectomy as well as after radiation therapy in the treatment of prostate cancer. The prevalence increases with age and a range of 11-34%. Different kinds of management are available. Surgical treatment is the most effective when incontinence is severe. The artificial urinary sphincter(AUS) is the gold standard, but urethral bulking agents, different types of male slings and the ProACT, can be used. Not all patients are suitable for surgical treatment for incontinence after radiation therapy. The aim of this study is to evaluate the efficiency of urinary incontinence (UI) and the impact on quality of life(QoL) using the penile clamp.
Study design, materials and methods
A prospective pilot study included patients with urinary leakage and penile clamps with a circumference of 4-6 cm (small), 7-9 cm (medium) and >10cm (large). Inclusion criteria consisted of good hand function, a full cognitive function and a minimum length of 3 cm and a circumference of 5 cm of the penis.
The first visit consisted of information and evaluation of the patient, collection of incontinence pads and measurement of the penis. Instruction on how to use the clamp, in two hours intervals and not during the night. One week later a telephone contact evaluates the use of the clamp. The final visit was after three months where the evaluation consisted of a pads weighting during the daytime before using the penile clamp and after 3 months of use. The duration was 4 hours of rest and 4 hours of normal physical activity with the penile clamp. Evaluation of leakage, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), incontinence-QoL (I-QoL) and a questionnaire on the actual handling of the penile clamp after 3 months of using the penile clamp. Approval of ethical application and signed informed consent was established.
The study included 25 patients. Two patients were excluded, one underwent surgery with AUS, and another encountered difficulties in using the clamp. All of the initial 25 patients sent us the questionnaires at the end of the trial, ICIQ-SF, I-QOL, and a questionnaire regarding handling the penile clamp. The results showed a median reduction of urinary leakage of 68% at rest and 66% during physical activity and a low frequency of complications using the clamp. ICIQ-SF showed a slight improvement of 6%. I-QoL showed a median score of 55 and increased to 58 after using the clamp. The patients also completed a questionnaire with simple questions regarding this specific penile clamp. 12 out of 23 (52%) were satisfied with the clamp, 18 out of 23 (78%) would recommend the clamp to others with a similar problem. However, 6 out of 23 (26%) found it uncomfortable to use.
Interpretation of results
The results showed a median reduction of urinary leakage of 68% at rest and 66% during physical activity. Without the clamp at rest, a median of 93 g (0-296) urinary leakage and during physical activity a median of 191 g (15-578). After 3 months of clamp usage the results showed at rest a median of 30 g (0-130) and during physical activity a median of 65 g (0 - 256).
ICIQ-SF showed a slight improvement of 6%. Without the clamp a median score of 18 (11-21) and after 3 months of clamp usage, a median score of 17 (5-21). I-QoL showed a median score of 55 (31-100) and increased to 58 (31-108) after using the clamp.The patients also completed a questionnaire with simple questions regarding this specific penile clamp. When they were asked about how satisfied they were with the total experience with the clamp, 12 out of 23 (52%) were satisfied with the clamp. When asked if they recommend the clamp to others with a similar problem ,18 out of 23 (78%) would recommend the clamp . However, 6 out of 23 (26%) found it uncomfortable to use. One of the patients used the clamp for more than 6 hours and accused swelling of the distal part of the penis and even a small lesion that healed completely after a few days.