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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00982241
Other study ID # OABdrinkstudy
Secondary ID
Status Withdrawn
Phase N/A
First received September 22, 2009
Last updated July 23, 2012
Start date July 2009

Study information

Verified date September 2009
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The researchers want to investigate how fluid intake influences the symptoms of OAB. The researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while filling in an standard micturation diary for 2 days. This micturation diary is coupled to: collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine samples will be analysed for osmolality by the clinical chemistry department.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- OAB patients

Exclusion Criteria:

- benign prostatic hyperplasia

- neurogenic detrusor overactivity

- urine tract infection

- anticholinergics

- intravesical botulin toxin

- cardiac failure

- renal insufficiency

- sacral neurostimulation

- percutaneous neurostimulation

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Dietary Supplement:
water
drinking water / normal dietary fluids for oral intake

Locations

Country Name City State
Netherlands Dept. of Urology, Radboud University Nijmegen Medical Centre Nijmegen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary urine osmolality 2 days No
Primary PPIUS urge-score 2 days No
Secondary urine pH 2 days No
Secondary PPIUS urge score 2 days No
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