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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous perineal stimulation | Experimental | 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. |
|
| Anal stimulation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous perineal stimulation | Other | Surface stimulation |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
As it is a prostatic pathology, only men participate in the study
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| Name | Affiliation | Role |
|---|---|---|
| Regina Pané | RAPbarcelona | Principal Investigator |
| Inés RamÃrez | RAPbarcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regina Pané Alemany | Barcelona | 08037 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33509164 | Derived | Pane-Alemany R, Ramirez-Garcia I, Carralero-Martinez A, Blanco-Ratto L, Kauffmann S, Sanchez E. Efficacy of transcutaneous perineal electrostimulation versus intracavitary anal electrostimulation in the treatment of urinary incontinence after a radical prostatectomy: randomized controlled trial study protocol. BMC Urol. 2021 Jan 28;21(1):12. doi: 10.1186/s12894-020-00718-y. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Single Blind
| Anal stimulation |
| Other |
Intra-cavitary stimulation |
|
| Assess adverse effects | Identify adverse effects for each of the treatments | 10 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |