Pelvic Floor, Radical Prostatectomy, Urinary Incontinence
Conditions
Brief summary
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
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.
Interventions
OTHERTranscutaneous perineal stimulation
Surface stimulation
OTHERAnal stimulation
Intra-cavitary stimulation
Sponsors
RAPbarcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single Blind
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of transcutaneous perineal stimulation compared to anal stimulation | Baseline, 6 and 10 weeks | A change of the urine grams last in 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asses quality of life | Baseline and 10 weeks | 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. |
| Assess adverse effects | 10 weeks | Identify adverse effects for each of the treatments |
Countries
Spain
Outcome results
None listed