Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation
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|ClinicalTrials.gov Identifier: NCT03587402|
Recruitment Status : Not yet recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence Radical Prostatectomy Pelvic Floor||Other: Transcutaneous perineal stimulation Other: Anal stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Single Blind|
|Official Title:||Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||July 30, 2019|
|Estimated Study Completion Date :||October 20, 2020|
Experimental: 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.
Other: Transcutaneous perineal stimulation
Active Comparator: 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.
Other: Anal stimulation
- Effects of transcutaneous perineal stimulation compared to anal stimulation [ Time Frame: Baseline, 6 and 10 weeks ]A change of the urine grams last in 24 hours
- Asses quality of life [ Time Frame: 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 [ Time Frame: 10 weeks ]Identify adverse effects for each of the treatments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587402
|Contact: Regina Panéfirstname.lastname@example.org|
|Contact: Inés Ramírezemail@example.com|
|Principal Investigator:||Regina Pané||RAPbarcelona|
|Study Director:||Inés Ramírez||RAPbarcelona|