OBJECTIVES: To assess the safety, efficacy, comfort, and patient satisfaction with three penile compression devices: the Cunningham clamp, C3, and U-Tex. METHODS: The devices were tested in random order in a multiple-period, crossover study design using a Latin squares configuration. The subjects had undergone radical prostatectomy 6 months or more before the study, had no neurologic or cognitive impairment, and had not undergone radiotherapy. Baseline penile Doppler ultrasonography was followed by ultrasound scanning with each device. In random order, subjects completed a 4-hour pad test, with and without each device, and the questionnaire. RESULTS:Twelve men completed the study. The mean Mini-Mental State Examination score was 29.6 (SD 1.2, range 27 to 30). The mean urine loss at baseline was 122.8 g (SD 130.8). The mean urine loss with each device was 53.3 g (SD 65.7) with the U-Tex, 32.3 g (SD 24.3) with C3, and 17.1 g (SD 21.3) with the Cunningham clamp (P <0.05). No device had an impact on the resistive index; the C3 and U-Tex allowed good cavernosal artery flow, and the Cunningham clamp significantly lowered the distal blood flow velocity (from 12.5 to 7.3 cm/s [left systolic velocity] to 9.5 cm/s [right systolic velocity]) even at the loosest setting. The Cunningham clamp was ranked positively by 10 of 12 men; 2 of 12 men rated the C3 positively; none rated the U-Tex positively. CONCLUSIONS: The Cunningham device was the most efficacious and most acceptable to users, but also contributed to reduced systolic velocity in all men. None of the devices completely eliminated urine loss when applied at a comfortable pressure. Individualized instruction to cognitively capable men is necessary to ensure appropriate application, comfort, and fit.
RCT Entities:
OBJECTIVES: To assess the safety, efficacy, comfort, and patient satisfaction with three penile compression devices: the Cunningham clamp, C3, and U-Tex. METHODS: The devices were tested in random order in a multiple-period, crossover study design using a Latin squares configuration. The subjects had undergone radical prostatectomy 6 months or more before the study, had no neurologic or cognitive impairment, and had not undergone radiotherapy. Baseline penile Doppler ultrasonography was followed by ultrasound scanning with each device. In random order, subjects completed a 4-hour pad test, with and without each device, and the questionnaire. RESULTS: Twelve men completed the study. The mean Mini-Mental State Examination score was 29.6 (SD 1.2, range 27 to 30). The mean urine loss at baseline was 122.8 g (SD 130.8). The mean urine loss with each device was 53.3 g (SD 65.7) with the U-Tex, 32.3 g (SD 24.3) with C3, and 17.1 g (SD 21.3) with the Cunningham clamp (P <0.05). No device had an impact on the resistive index; the C3 and U-Tex allowed good cavernosal artery flow, and the Cunningham clamp significantly lowered the distal blood flow velocity (from 12.5 to 7.3 cm/s [left systolic velocity] to 9.5 cm/s [right systolic velocity]) even at the loosest setting. The Cunningham clamp was ranked positively by 10 of 12 men; 2 of 12 men rated the C3 positively; none rated the U-Tex positively. CONCLUSIONS: The Cunningham device was the most efficacious and most acceptable to users, but also contributed to reduced systolic velocity in all men. None of the devices completely eliminated urine loss when applied at a comfortable pressure. Individualized instruction to cognitively capable men is necessary to ensure appropriate application, comfort, and fit.
Authors: J N Nyarangi-Dix; D Schultz-Lampel; U Hohenfellner; J Huber; G Hatiboglu; N Djakovic; A Haferkamp; M Hohenfellner Journal: Urologe A Date: 2010-04 Impact factor: 0.639
Authors: Coral A Anderson; Muhammad Imran Omar; Susan E Campbell; Kathleen F Hunter; June D Cody; Cathryn M A Glazener Journal: Cochrane Database Syst Rev Date: 2015-01-20