Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Preservation and Restoration of Urinary Continence and Erectile Function and in the Treatment of Erectile Dysfunction and Urinary Incontinence in Conjunction With Nerve Sparing Radical Prostatectomy
Brief Summary: After radical prostatectomy nerve damage in the pelvic floor usually occurs. This causes side effects in the form of incontinence and erectile dysfunction.

It has previously been shown that one can stimulate the nerves of the pelvic floor by means of transcutaneous mechanical nerve stimulation (TMNS) done through vibration. This study will examine the effect of TMNS in the preservation and restoration of urinary continence and erectile function and in the treatment of urinary incontinence and erectile dysfunction in conjunction with radical prostatectomy.

The theory is that by means of TMNS one can stimulate the nerves of the pelvic floor and the penis which may improve their function and there by prevent or minimize the occurrence of incontinence and erectile dysfunction following pelvic surgery. Vibration may also help to eliminate these symptoms once they have occurred. It is possible that TMNS will also directly increase the blood flow in the cavernosal tissue thus aiding in the preservation of this tissue. In case the improved nerve function is not great enough to secure satisfactory erectile function in itself it may still improve the effect of PDE-5-inhibitors.

In pilot studies TMNS has already shown an effect in the treatment of urinary continence.

In this study the patients will be randomized to either TMNS treatment or no TMNS treatment. In both groups the patients will participate in a pelvic floor muscle training program. In the group receiving active treatment this will be supplemented by TMNS treatment. The two groups will be evaluated and compared with regard to erectile function time to continence after surgery.


Options:
A: Intervention Type: BEHAVIORAL; Name: exercise intervention; Assigned to Arm(s): N/A | Intervention Type: OTHER; Name: questionnaire administration; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: biofeedback; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: management of therapy complications; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: psychosocial assessment and care; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): N/A
B: Arm Label: TMNS and pelvic floor muscle training; Type: EXPERIMENTAL; Interventions: Device: Transcutaneous mechanical nerve stimulation (TMNS) | Arm Label: Pelvic floor muscle training only; Type: ACTIVE_COMPARATOR; Interventions: Other: Pelvic floor muscle training | Intervention Type: DEVICE; Name: Transcutaneous mechanical nerve stimulation (TMNS); Assigned to Arm(s): TMNS and pelvic floor muscle training | Intervention Type: OTHER; Name: Pelvic floor muscle training; Assigned to Arm(s): Pelvic floor muscle training only
C: Arm Label: Rehabilitation; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: RePCa A | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: RePCa A | Intervention Type: BEHAVIORAL; Name: RePCa A; Assigned to Arm(s): Control, Rehabilitation
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Strength training of the pelvic floor muscles, Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist | Intervention Type: BEHAVIORAL; Name: Strength training of the pelvic floor muscles; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist; Assigned to Arm(s): 1, 2

Answer: B