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Completed

NCT Number: NCT03574298

Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

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

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Key information

Conditions

Lower Urinary Tract Symptoms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Neuro-urology, Tenon hospital

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Perineal Radiotherapy
  • Surgery for stress urinary incontinence

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pierre and Marie Curie University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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