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Overactive Bladder (OAB) Drink Advice Study

Primary Purpose

Overactive Bladder Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
water
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overactive Bladder Syndrome focused on measuring OAB, urine, osmolality, urge, fluid intake, PPIUS, urge score, bladder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Urology, Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

normal fluid intake

high fluid intake

low fluid intake

Arm Description

1500 ml /day (+/- 300 ml) for 2,5 days

2400 ml/day (+/- 300 ml )for 2,5 days

fluid intake 900 ml/day (+/- 300ml) for 2,5 days

Outcomes

Primary Outcome Measures

urine osmolality
PPIUS urge-score

Secondary Outcome Measures

urine pH
PPIUS urge score

Full Information

First Posted
September 22, 2009
Last Updated
July 23, 2012
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00982241
Brief Title
Overactive Bladder (OAB) Drink Advice Study
Official Title
Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in enrolling participants
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
OAB, urine, osmolality, urge, fluid intake, PPIUS, urge score, bladder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal fluid intake
Arm Type
Active Comparator
Arm Description
1500 ml /day (+/- 300 ml) for 2,5 days
Arm Title
high fluid intake
Arm Type
Active Comparator
Arm Description
2400 ml/day (+/- 300 ml )for 2,5 days
Arm Title
low fluid intake
Arm Type
Active Comparator
Arm Description
fluid intake 900 ml/day (+/- 300ml) for 2,5 days
Intervention Type
Dietary Supplement
Intervention Name(s)
water
Intervention Description
drinking water / normal dietary fluids for oral intake
Primary Outcome Measure Information:
Title
urine osmolality
Time Frame
2 days
Title
PPIUS urge-score
Time Frame
2 days
Secondary Outcome Measure Information:
Title
urine pH
Time Frame
2 days
Title
PPIUS urge score
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Heesakkers, dr. MD
Organizational Affiliation
dept of Urology, Radboud University Nijmegen Medical Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Urology, Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

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Overactive Bladder (OAB) Drink Advice Study

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