Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Copenhagen University Hospital at Herlev

Status and phase: Unknown; Phase 3

Conditions: Radical Prostatectomy; Urinary Incontinence

Treatments: Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)

Study type: Interventional

Funder types: Other

Identifiers

NCT01540656

H-2-2011-118

Details and patient eligibility

About

During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve Stimulation (TMNS) in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome. Furthermore pilot studies in men who are incontinent after a radical prostatectomy have shown promising results. A randomized investigation of TMNS applied in the immediate period after a radical prostatectomy to investigate effects on both continence and erectile function is on going.

The present study aims to treat urinary incontinence in men who are still incontinent more than 1 year after a radical prostatectomy. A medical vibrator is used daily for a period of 6 weeks and the results of the treatment is then evaluated. The participants will be randomized to 2 groups. Group 1 starts vibration treatment at base line and group 2 starts after 6 weeks when group 1 is done. The groups are compared at baseline, at 6 weeks and at 12 weeks.

The stimulation will be performed at the frenulum of the glans penis every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.

If the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing normal continence in men after a radical prostatectomy.

Enrollment: 39 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men who have undergone a radical prostatectomy at least 1 year prior to enrollment
• Incontinence induced by the surgery (at least 8 g/24 hours)
• Capable of understanding study information and following treatment

Exclusion criteria

• Incontinence before radical prostatectomy
• Treatment with anticholinergic medications
• Radiation or hormone treatment
• Previous surgical treatment of incontinence
• Acute illness (including infection, trauma and haematuria)
• Faecal incontinence
• Known neurological disease
• Known Bladder pathology on cystoscopy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Group 1

Active Comparator group

Description:

This group will receive immediate TMNS treatment beginning at baseline and ending at the 6 week point of the study.

Treatment:

Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)

Group 2

Active Comparator group

Description:

This group will receive delayed TMNS treatment beginning at the 6 week point of the study and ending at 12 weeks.

Treatment:

Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)