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OpenTrials
Completed

NCT Number: NCT03587402

Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pelvic Floor Radical Prostatectomy Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Regina Pané Alemany

Barcelona, 08037, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous perineal stimulation

Other

Surface stimulation

Anal stimulation

Other

Intra-cavitary stimulation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

RAPbarcelona

Other

Registry information

Official study title

Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 16, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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