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Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

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ClinicalTrials.gov Identifier: NCT03574298
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Gérard Amarenco, Pierre and Marie Curie University

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

Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 30, 2018



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Duration (time) [ Time Frame: 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).

  2. Maximum [ Time Frame: 1 day: During electromyographic recording ]
    The maximum of contraction of the electromyographic activity external anal sphincter.

  3. Area under the curve [ Time Frame: 1 day: During electromyographic recording ]
    the area under the curve of the electromyographic activity external anal sphincter.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients consulting for urodynamic assessment
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Perineal Radiotherapy
  • Surgery for stress urinary incontinence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574298


Locations
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France
Department of Neuro-urology, Tenon hospital
Paris, France, 75020
Sponsors and Collaborators
Pierre and Marie Curie University
Investigators
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Principal Investigator: Gérard Amarenco, PhD GREEN GRC-01, Neuro-urology, hôpital Tenon

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Responsible Party: Gérard Amarenco, Head of Neuro-Urology department, Tenon hospital, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT03574298     History of Changes
Other Study ID Numbers: P GREEN 0001
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gérard Amarenco, Pierre and Marie Curie University:
Radical prostatectomy
urinary incontinence
pelvic floor muscle
reaction time
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms