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CompletedNCT03574298Updated Sep 25, 2019

Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

An observational study in Lower Urinary Tract Symptoms, sponsored by Pierre and Marie Curie University. Completed at 1 site in France. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by Pierre and Marie Curie University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
22
Ages
18 Years to 100 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Lower Urinary Tract Symptoms

Keywords

  • Radical prostatectomy
  • urinary incontinence
  • pelvic floor muscle
  • reaction time
03

In context

Lower Urinary Tract Symptoms

406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.

This study's enrollment of 22 is below the median of 179 across 132 observational studies indexed under Lower Urinary Tract Symptoms.

Browse Lower Urinary Tract Symptoms studies →

Lead sponsor

Pierre and Marie Curie University is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients consulting for urodynamic assessment

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Perineal Radiotherapy
  • Surgery for stress urinary incontinence
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day: During electromyographic recording

Secondary outcomes

  1. 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).

    Time frame: 1 day: During electromyographic recording

  2. Maximum

    The maximum of contraction of the electromyographic activity external anal sphincter.

    Time frame: 1 day: During electromyographic recording

  3. Area under the curve

    the area under the curve of the electromyographic activity external anal sphincter.

    Time frame: 1 day: During electromyographic recording

07

Study locations

1 site
  • Department of Neuro-urology, Tenon hospital
    Paris, 75020, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03574298
Lead sponsor
Pierre and Marie Curie University
Responsible party
Gérard Amarenco (Head of Neuro-Urology department, Tenon hospital, Pierre and Marie Curie University) — Principal investigator
First posted
Jun 29, 2018
Start date
Jun 18, 2018
Primary completion
Jun 30, 2018
Completion
Jul 30, 2018
Last update
Sep 25, 2019

Study contacts

Gérard Amarenco, PhD
principal investigator · GREEN GRC-01, Neuro-urology, hôpital Tenon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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