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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
Sponsor:
Information provided by (Responsible Party):
Regina Pané Alemany, RAPbarcelona

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
Urinary Incontinence Radical Prostatectomy Pelvic Floor Other: Transcutaneous perineal stimulation Other: Anal stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single Blind
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. Assess adverse effects [ Time Frame: 10 weeks ]
    Identify adverse effects for each of the treatments



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   As it is a prostatic pathology, only men participate in the study
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Regina Pané 699038212 paneregina@gmail.com
Contact: Inés Ramírez 677745765 ines.ramirez@rapbarcelona.com

Sponsors and Collaborators
RAPbarcelona
Investigators
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Principal Investigator: Regina Pané RAPbarcelona
Study Director: Inés Ramírez RAPbarcelona

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Responsible Party: Regina Pané Alemany, Principal investigator, RAPbarcelona
ClinicalTrials.gov Identifier: NCT03587402     History of Changes
Other Study ID Numbers: RAP47747176G
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders