NCT00982241

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.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

July 24, 2012

Status Verified

September 1, 2009

Enrollment Period

1.4 years

First QC Date

September 22, 2009

Last Update Submit

July 23, 2012

Conditions

Overactive Bladder Syndrome

Keywords

OABurineosmolalityurgefluid intakePPIUSurge scorebladder

Outcome Measures

Primary Outcomes (2)

  • urine osmolality

    2 days

  • PPIUS urge-score

    2 days

Secondary Outcomes (2)

  • urine pH

    2 days

  • PPIUS urge score

    2 days

Study Arms (3)

normal fluid intake

ACTIVE COMPARATOR

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

Dietary Supplement: water

high fluid intake

ACTIVE COMPARATOR

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

Dietary Supplement: water

low fluid intake

ACTIVE COMPARATOR

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

Dietary Supplement: water

Interventions

waterDIETARY_SUPPLEMENT

drinking water / normal dietary fluids for oral intake

high fluid intakelow fluid intakenormal fluid intake

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OAB patients

You may not qualify if:

  • benign prostatic hyperplasia
  • neurogenic detrusor overactivity
  • urine tract infection
  • anticholinergics
  • intravesical botulin toxin
  • cardiac failure
  • renal insufficiency
  • sacral neurostimulation
  • percutaneous neurostimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Urology, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • John Heesakkers, dr. MD

    dept of Urology, Radboud University Nijmegen Medical Centre

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Last Updated

July 24, 2012

Record last verified: 2009-09

Locations

NL(1)