Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation

RAPbarcelona

Status: Completed

Conditions: Pelvic Floor; Radical Prostatectomy; Urinary Incontinence

Treatments: Other: Transcutaneous perineal stimulation; Other: Anal stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03587402

RAP47747176G

Details and patient eligibility

About

This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy.

Half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.

Full description

Pelvic floor muscle training is the most common non-invasive intervention for urinary incontinence secondary to radical prostatectomy. Perineal stimulation has a significant positive impact on the early recovery of urinary continence after this intervention.

The perineal stimulation can be applied with surface electrodes or with an intra-cavitary probe placed in the anus. The two techniques are commonly used. Each techniques stimulates different anatomical points of perineum, and it is a question if both have the same effectiveness or, one of the two techniques has greater effect than the other.

Enrollment: 70 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having undergone a radical prostatectomy surgical procedure.
• Presenting involuntary urine losses after radical prostatectomy intervention. (IU grade I, II or III)
• Do not exceed the year since the surgical intervention.
• Accept to participate in the study and grant signed informed consent.

Exclusion criteria

• Follow a pharmacological treatment for the UI.
• Presenting anatomical malformations of the pelvic floor musculature.
• Carry pacemaker.
• Present anal fistulas.
• suffer from serious psychic disorders.
• Presenting lower urinary tract infections.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Transcutaneous perineal stimulation

Experimental group

Description:

Patient is asked to lie down with legs slightly bend and two adhesive electrodes are attached transcutaneous on base of penis and on perineum. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.

Treatment:

Other: Transcutaneous perineal stimulation

Anal stimulation

Active Comparator group

Description:

Patient is asked to lie down with legs slightly bend and an electrical probe is inserted into the anus. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.

Treatment:

Other: Anal stimulation