Back to resultsEffects of Transcutaneous Perineal Stimulation Versus Anal Stimulation
Primary Purpose
Urinary Incontinence, Radical Prostatectomy, Pelvic Floor
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transcutaneous perineal stimulation
Anal stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility 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.
Sites / Locations
- Regina Pané Alemany
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transcutaneous perineal stimulation
Anal stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Effects of transcutaneous perineal stimulation compared to anal stimulation
A change of the urine grams last in 24 hours
Secondary Outcome Measures
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.
Assess adverse effects
Identify adverse effects for each of the treatments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03587402
Brief Title
Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation
Official Title
Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
October 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAPbarcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Radical Prostatectomy, Pelvic Floor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single Blind
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous perineal stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Anal stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Transcutaneous perineal stimulation
Intervention Description
Surface stimulation
Intervention Type
Other
Intervention Name(s)
Anal stimulation
Intervention Description
Intra-cavitary stimulation
Primary Outcome Measure Information:
Title
Effects of transcutaneous perineal stimulation compared to anal stimulation
Description
A change of the urine grams last in 24 hours
Time Frame
Baseline, 6 and 10 weeks
Secondary Outcome Measure Information:
Title
Asses quality of life
Description
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.
Time Frame
Baseline and 10 weeks
Title
Assess adverse effects
Description
Identify adverse effects for each of the treatments
Time Frame
10 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
As it is a prostatic pathology, only men participate in the study
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regina Pané
Organizational Affiliation
RAPbarcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Inés Ramírez
Organizational Affiliation
RAPbarcelona
Official's Role
Study Director
Facility Information:
Facility Name
Regina Pané Alemany
City
Barcelona
ZIP/Postal Code
08037
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33509164
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation
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