Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-10-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Incontinence Radical Prostatectomy Pelvic Floor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Single Blind

Study Groups

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Transcutaneous perineal stimulation

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.

Group Type EXPERIMENTAL

Transcutaneous perineal stimulation

Intervention Type OTHER

Surface stimulation

Anal stimulation

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.

Group Type ACTIVE_COMPARATOR

Anal stimulation

Intervention Type OTHER

Intra-cavitary stimulation

Interventions

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Transcutaneous perineal stimulation

Surface stimulation

Intervention Type OTHER

Anal stimulation

Intra-cavitary stimulation

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No