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Clinical Trials/NCT03574298
NCT03574298
Completed
Not Applicable

Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

Pierre and Marie Curie University1 site in 1 country22 target enrollmentJune 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
Pierre and Marie Curie University
Enrollment
22
Locations
1
Primary Endpoint
Latency (time)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 18, 2018
End Date
July 30, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Pierre and Marie Curie University
Responsible Party
Principal Investigator
Principal Investigator

Gérard Amarenco

Head of Neuro-Urology department, Tenon hospital

Pierre and Marie Curie University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Perineal Radiotherapy
  • Surgery for stress urinary incontinence

Outcomes

Primary Outcomes

Latency (time)

Time Frame: 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 Outcomes

  • Duration (time)(1 day: During electromyographic recording)
  • Maximum(1 day: During electromyographic recording)
  • Area under the curve(1 day: During electromyographic recording)

Study Sites (1)

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