Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03587402
• Other study ID #: RAP47747176G
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: October 6, 2020

Study information

• Verified date: October 2020
• Source: RAPbarcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 6, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Pelvic Floor
• Radical Prostatectomy
• Urinary Incontinence

Intervention

Other:
• Transcutaneous perineal stimulation
Surface stimulation
• Anal stimulation
Intra-cavitary stimulation

Locations

Country	Name	City	State
Spain	Regina Pané Alemany	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
RAPbarcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of transcutaneous perineal stimulation compared to anal stimulation	A change of the urine grams last in 24 hours	Baseline, 6 and 10 weeks
Secondary	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.	Baseline and 10 weeks
Secondary	Assess adverse effects	Identify adverse effects for each of the treatments	10 weeks