Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

NCT ID: NCT03574298

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2018-07-30

Brief Summary

This study evaluate the effect of radical prostatectomy on involuntary pelvic floor muscle contraction

Detailed Description

Radical prostatectomy may cause stress urinary incontinence (SUI). That poses problem in terms of quality of life. There are many treatment options available for patients with SUI, but the exact mechanism is not known. We compared, in continent and incontinent men post-radical prostatectomy, the correlation between the temporal course of pelvic floor activation during cough.

Simultaneously, recordings of electromyographic activity of external anal sphincter (EAS EMG) and external intercostal muscle (EIC EMG) during coughing will be made with a pair of pre-gelled electrodes. Cough effort cause an involuntary pelvic contraction. Intercostals muscles recording was chosen because they are one of the muscular components of cough initiation with diaphragm muscle. 24h pad-weighing test is used to quantify urinary incontinence. We will measure the latency between the onset of the EIC EMG and the EAS EMG (RT3), during a cough effort. We will also measure the duration of the contraction, the maximum EAS EMG activity and the area under the curve.

Conditions

Lower Urinary Tract Symptoms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Follow in neuro-urology for lower urinary tract symptoms
• Radical Prostatectomy

Exclusion Criteria

• Perineal Radiotherapy
• Surgery for stress urinary incontinence

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre and Marie Curie University

OTHER

Sponsor Role: lead

Responsible Party

Gérard Amarenco

Head of Neuro-Urology department, Tenon hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gérard Amarenco, PhD

Role: PRINCIPAL_INVESTIGATOR

GREEN GRC-01, Neuro-urology, hôpital Tenon

Locations

Department of Neuro-urology, Tenon hospital

Paris, , France

Countries

France

Other Identifiers

P GREEN 0001

Identifier Type: -

Identifier Source: org_study_id