NCT03587402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

June 27, 2018

Last Update Submit

October 6, 2020

Conditions

Urinary IncontinenceRadical ProstatectomyPelvic Floor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Asses quality of life

    Baseline and 10 weeks

  • Assess adverse effects

    10 weeks

Study Arms (2)

Transcutaneous perineal stimulation

EXPERIMENTAL

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

Anal stimulation

ACTIVE COMPARATOR

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

Interventions

Transcutaneous perineal stimulationOTHER

Surface stimulation

Transcutaneous perineal stimulation
Anal stimulationOTHER

Intra-cavitary stimulation

Anal stimulation

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAs it is a prostatic pathology, only men participate in the study
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Pané Alemany

Barcelona, 08037, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33509164DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Regina Pané

    RAPbarcelona

    PRINCIPAL INVESTIGATOR

  • Inés Ramírez

    RAPbarcelona

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 16, 2018

Study Start

February 1, 2019

Primary Completion

July 30, 2019

Study Completion

October 6, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)