Overactive Bladder (OAB) Drink Advice Study | NCT00982241

Studies
Overactive Bladder (OAB) Drink Advice Study

NCT00982241

Sponsor

Radboud University Medical Center

Status

Withdrawn

Last Update Posted

Jul 24, 2012Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Overactive Bladder Syndrome

Interventions

water

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in enrolling participants

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Not provided

First Submitted Date

Sep 22, 2009

First Submission Date that Met QC Criteria

Sep 22, 2009

First Posted Date

Sep 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2012

Last Update Posted Date

Jul 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
water	Dietary Supplement	drinking water / normal dietary fluids for oral intake	high fluid intake low fluid intake normal fluid intake

Measure	Description	Time Frame
urine osmolality		2 days
PPIUS urge-score		2 days

Measure	Description	Time Frame
urine pH		2 days
PPIUS urge score		2 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Heesakkers, dr. MD	dept of Urology, Radboud University Nijmegen Medical Centre	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Urology, Radboud University Nijmegen Medical Centre		Nijmegen	Gelderland	6500 HB	Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
D014867	Water

Ancestor Terms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477

Browse Leaves

Not provided

Browse Branches

Not provided