Urethral Sensory Profile: a New Technique to Evaluate Urethral Sensation Prospective Evaluation in Patients With or Without Neurological Disorders

Urethral Cyst Clinical Trial

Official title:

Urethral Sensory Profile: a New Technique to Evaluate Urethral Sensation Prospective Evaluation in Patients With or Without Neurological Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889783
• Other study ID #: GREEN-1-LW
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: September 6, 2016
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: August 2016
• Source: Groupe de Recherche Clinique en Neuro-Urologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

This is a routine evaluation of urethral sensation during urodynamic studies. The record has been realized retrospectively. The investigators propose a new way to represent urethral sensation, in a simple and non-invasive way.

Description:

All patients consulting for urodynamics were included. During the introduction of the urinary catheter for urodynamic evaluation, patients were asked to report pain and/or desire to void felt at every centimeter (cm)of insertion, on an analogic visual scale graded from 0 to 10. The USP was defined by the graphic representation of the successive values of these sensations , from the urinary meatus, to the urinary bladder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients consulting in our department for a urodynamic study

Exclusion Criteria:

• chronic pelvic pain

• difficulties for understanding or for communicating

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Nervous System Diseases
• Urethral Cyst

Intervention

Other:
• record of urethral pain sensation during urodynamics study
Record of pain using a VAS scale during the first catheterizing of urodynamics study, at every centimeter

Locations

Country	Name	City	State
France	Weglinski	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe de Recherche Clinique en Neuro-Urologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urethral Sensitive profile	record of urethral pain sensation during the first catheterizing of urodynamics study	mars 2015	Yes