Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Surface 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
Intra-cavitary stimulation
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Regina Pané Alemany | Barcelona | Spain | 08037 |
Sponsors and Collaborators
- RAPbarcelona
Investigators
- Principal Investigator: Regina Pané, RAPbarcelona
- Study Director: Inés Ramírez, RAPbarcelona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RAP47747176G