Lower Urinary Tract Symptoms Clinical Trial
Official title:
Filling and Emptying Cystometries: a Feasibility and Validation Study in Order to Simplify the Manometric Follow-up of Overactive Detrusor in Neurological Patients Under Anticholinergic or Botulinum Toxin Injections.
NCT number | NCT03255421 |
Other study ID # | P GREEN 01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 31, 2017 |
Est. completion date | September 29, 2017 |
Verified date | September 2019 |
Source | Pierre and Marie Curie University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | September 29, 2017 |
Est. primary completion date | August 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Follow in neuro-urology for lower urinary tract symptoms - Appointment for urodynamic assessment Exclusion Criteria: - detrusor overactivity - micturition during or at the end of the filling cystometry |
Country | Name | City | State |
---|---|---|---|
France | Department of Neuro-urology, Tenon hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Pierre and Marie Curie University |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement | Agreement between the two cystometries evaluated using a kappa coefficient. | 1 Day : during the urodynamic assessment | |
Secondary | Correlation | Correlation between the pressures during the two cystometries. | 1 Day : during the urodynamic assessment |
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