Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation

Study Overview
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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.

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.

Official Title
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Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy

Conditions
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Urinary Incontinence, Radical Prostatectomy, Pelvic Floor

Intervention / Treatment
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* Other: Transcutaneous perineal stimulation
* Other: Anal stimulation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous perineal stimulation<br>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. | Other: Transcutaneous perineal stimulation<br>* Surface stimulation<br>|
| Active Comparator: Anal stimulation<br>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. | Other: Anal stimulation<br>* Intra-cavitary stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of transcutaneous perineal stimulation compared to anal stimulation | A change of the urine grams last in 24 hours | Baseline, 6 and 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asses quality of life | Asses the perceived quality of life of patients in the study. It will be evaluated with the questionnaire I-QOL. It measures the effect of urinary incontinence on quality of life. The I-QOL have 22 items and is divided into 3 subscales: avoidance and limiting behavior, psychosocial impact, social embarrassment. More puntuation means more quality of life. | Baseline and 10 weeks | 
| Assess adverse effects | Identify adverse effects for each of the treatments | 10 weeks |