NCT03272386

Brief Summary

The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to evaluate the understanding and acceptability of the proposed instructions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

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

Study Start

First participant enrolled

July 31, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

August 16, 2017

Last Update Submit

September 24, 2019

Conditions

Lower Urinary Tract Symptoms

Keywords

pelvic floor musclesinstructionassessmentacceptabilityunderstanding

Outcome Measures

Primary Outcomes (1)

  • Description of the instructions used by the professionals

    Qualitative description of the instructions and selection of the most frequent instructions.

    1 day during the consultation

Secondary Outcomes (1)

  • Acceptability, understanding and selection of the best instruction by the subjects

    1 day during the consultation

Study Arms (1)

Observational study

Observational study with patients over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included.

Other: Observational study

Interventions

Observational studyOTHER

Completing a questionnaire

Observational study

Eligibility Criteria

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

Patients consulting in a tertiary center in neuro-urology.

You may qualify if:

  • Follow in neuro-urology
  • Lower urinary tract symptoms

You may not qualify if:

  • Can't speak French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neuro-urology, hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Observation

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Gérard Amarenco, PhD

    UPMC, Sorbonne Université, Univ Paris 6, service neuro-urologie, hôpital TENON, Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 16, 2017

First Posted

September 5, 2017

Study Start

July 31, 2017

Primary Completion

September 18, 2017

Study Completion

September 29, 2017

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

FR(1)