Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

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

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Department of Neuro-urology, Tenon hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients consulting for urodynamic assessment

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Perineal Radiotherapy
• Surgery for stress urinary incontinence

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency (time)	The time (latency) between the onset of the external intercostal muscle (EIC EMG) and the electromyographic activity of external anal sphincter (EAS EMG), during a cough effort.	1 day: During electromyographic recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration (time)	The duration of contraction of external anal sphincter (defined as the time between the onset of the electromyographic activity of external anal sphincter and the end of the electromyographic activity of external anal sphincter).	1 day: During electromyographic recording
Maximum	The maximum of contraction of the electromyographic activity external anal sphincter.	1 day: During electromyographic recording
Area under the curve	the area under the curve of the electromyographic activity external anal sphincter.	1 day: During electromyographic recording

Collaborators and Investigators

• Sponsor: Pierre and Marie Curie University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Radical prostatectomy; pelvic floor muscle; urinary incontinence; reaction time
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: P GREEN 0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No