Lower Urinary Tract SymptomsNCT03574298
Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction
An observational study of Lower Urinary Tract Symptoms, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
This study evaluate the effect of radical prostatectomy on involuntary pelvic floor muscle contraction Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2018to 30 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting for urodynamic assessment
Who may be able to join
- Follow in neuro-urology for lower urinary tract symptoms
- Radical Prostatectomy
Who cannot join
- Perineal Radiotherapy
- Surgery for stress urinary incontinence
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Radical prostatectomy, urinary incontinence, pelvic floor muscle, reaction time
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day: During electromyographic recording
Secondary outcomes (3)
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).
Measured: 1 day: During electromyographic recording
Maximum
The maximum of contraction of the electromyographic activity external anal sphincter.
Measured: 1 day: During electromyographic recording
Area under the curve
the area under the curve of the electromyographic activity external anal sphincter.
Measured: 1 day: During electromyographic recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start18 Jun 2018
- Primary completion30 Jun 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre and Marie Curie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gérard Amarenco, Pierre and Marie Curie University
- Investigators
- Gérard Amarenco, PhD, Principal investigator, GREEN GRC-01, Neuro-urology, hôpital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574298
- Sponsor's protocol ID
- P GREEN 0001
- Status last verified
- Sep 2019
- First submitted
- 18 Jun 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction
- ClinicalTrials.gov ID
- NCT03574298
- Acronym / sponsor ID
- P GREEN 0001
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Radical prostatectomy, urinary incontinence, pelvic floor muscle, reaction time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting for urodynamic assessment
Key inclusion criteria (2 listed)
- Follow in neuro-urology for lower urinary tract symptoms
- Radical Prostatectomy
Key exclusion criteria (2 listed)
- Perineal Radiotherapy
- Surgery for stress urinary incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Duration (time)
Time frame: 1 day: During electromyographic recording
Maximum
Time frame: 1 day: During electromyographic recording
Area under the curve
Time frame: 1 day: During electromyographic recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gérard Amarenco, PhD principal investigator
GREEN GRC-01, Neuro-urology, hôpital Tenon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by Pierre and Marie Curie University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency (time) (time frame: 1 day: During electromyographic recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.