Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

Completed

• Conditions: Lower Urinary Tract Symptoms

• Registration Number: NCT03574298
• Lead Sponsor: Pierre and Marie Curie University

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.

Study Timeline

• Study Start: 2018-06-18
• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-06-29
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

• Perineal Radiotherapy
• Surgery for stress urinary incontinence

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Latency (time)	1 day: During electromyographic recording	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.

Secondary Outcome Measures

Name	Time	Method
Duration (time)	1 day: During electromyographic recording	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).
Maximum	1 day: During electromyographic recording	The maximum of contraction of the electromyographic activity external anal sphincter.
Area under the curve	1 day: During electromyographic recording	the area under the curve of the electromyographic activity external anal sphincter.

Trial Locations

Locations (1)

Department of Neuro-urology, Tenon hospital; 🇫🇷 Paris, France