Overactive Bladder (OAB) Drink Advice Study

Overactive Bladder Syndrome Clinical Trial

Official title:

Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00982241
• Other study ID #: OABdrinkstudy
• Status: Withdrawn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• Status: Withdrawn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. 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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

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