Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574298
• Other study ID #: P GREEN 0001
• Status: Completed
• Start date: June 18, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: September 2019
• Source: Pierre and Marie Curie University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Follow in neuro-urology for lower urinary tract symptoms

• Radical Prostatectomy

Exclusion Criteria:

• Perineal Radiotherapy

• Surgery for stress urinary incontinence

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Locations

Country	Name	City	State
France	Department of Neuro-urology, Tenon hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pierre and Marie Curie University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Maximum	The maximum of contraction of the electromyographic activity external anal sphincter.	1 day: During electromyographic recording
Secondary	Area under the curve	the area under the curve of the electromyographic activity external anal sphincter.	1 day: During electromyographic recording