NCT03255421

Brief Summary

This study evaluate the feasibility and the accuracy of an emptying cystometry in order to simplify the manometric follow-up of overactive detrusor in neurological patients under anticholinergic or botulinum toxin injections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 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

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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
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2017

Completed
1 month 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

28 days

First QC Date

August 16, 2017

Last Update Submit

September 24, 2019

Conditions

Lower Urinary Tract Symptoms

Keywords

urodynamicbackwards cystometryreverse cystometryfollow-up

Outcome Measures

Primary Outcomes (1)

  • Agreement

    Agreement between the two cystometries evaluated using a kappa coefficient.

    1 Day : during the urodynamic assessment

Secondary Outcomes (1)

  • Correlation

    1 Day : during the urodynamic assessment

Study Arms (1)

Patients enrolled

Patients over 18 years old, consulting for lower urinary tract symptoms and performing an urodynamic examination with a cystometry in a tertiary center are included. First pressure measurement in the bladder during the classic cystometry. Second measurement of bladder pressures during the bladder emptying.

Other: Pressure measurement

Interventions

Pressure measurementOTHER

Observational study No intervention, only fragmenting the emptying of the bladder

Patients enrolled

Eligibility Criteria

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

Patients consulting for an urodynamic assessment in a tertiary center in neuro-urology

You may qualify if:

  • Follow in neuro-urology for lower urinary tract symptoms
  • Appointment for urodynamic assessment

You may not qualify if:

  • detrusor overactivity
  • micturition during or at the end of the filling cystometry

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 Symptoms

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

August 16, 2017

First Posted

August 21, 2017

Study Start

July 31, 2017

Primary Completion

August 28, 2017

Study Completion

September 29, 2017

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

FR(1)