NCT03574298

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

12 days

First QC Date

June 18, 2018

Last Update Submit

September 24, 2019

Conditions

Lower Urinary Tract Symptoms

Keywords

Radical prostatectomyurinary incontinencepelvic floor musclereaction time

Outcome Measures

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.

    1 day: During electromyographic recording

Secondary Outcomes (3)

  • Duration (time)

    1 day: During electromyographic recording

  • Maximum

    1 day: During electromyographic recording

  • Area under the curve

    1 day: During electromyographic recording

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting for urodynamic assessment

You may qualify if:

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

You may not qualify if:

  • Perineal Radiotherapy
  • Surgery for stress urinary incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuro-urology, Tenon hospital

Paris, 75020, France

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsUrinary Incontinence

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Gérard Amarenco, PhD

    GREEN GRC-01, Neuro-urology, hôpital Tenon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neuro-Urology department, Tenon hospital

Study Record Dates

First Submitted

June 18, 2018

First Posted

June 29, 2018

Study Start

June 18, 2018

Primary Completion

June 30, 2018

Study Completion

July 30, 2018

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

FR(1)