Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00481728

Purpose

Measuring sympathetic skin response or heart rate variability can provide an objective biomarker of bladder sensation and its modulation by drug with potential to treat overactive bladder.

Condition	Intervention	Phase
Overactive Bladder	Drug: Tolterodine Procedure: Filling cystometry Procedure: Intravesical neurostimulation	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	Evaluation of Sympathetic Skin Responses and Heart Rate Variability as Objective Measures of Bladder Sensation - a Double Blind Third Party Open Placebo Controlled Randomised Study Using a Single Dose of Tolterodine in Patients With Idiopathic Overactive Bladder and Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients

Secondary Outcome Measures:

To investigate the correlation between the changes in heart rate variability and sympathetic skin response evoked by filling cystometry and intravesical neurostimulation in OAB patients. [ Time Frame: duration of study ] [ Designated as safety issue: No ]
To determine whether there is a difference in the stimulus response relationship for the evoked changes in HRV and SSR between healthy volunteers and OAB patients. [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	June 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tolterodine	Drug: Tolterodine Single dose per patient as determined by protocol. Procedure: Filling cystometry This is a procedure. Procedure: Intravesical neurostimulation This is a procedure.

Detailed Description:

Evaluation of the link between bladder sensation and changes in skin electrical conductance and heart rate.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female, healthy volunteers or OAB patients 18-65 years old, non pregnant and non lactating

Exclusion Criteria:

History of lower urinary tract pathology
Excessive alcohol and tobacco consumption
Treatment with investigational drug in the last 30 days
Abnormal ECG trace
Conditions that would contraindicate the use of tolterodine or any other anti muscarinic agent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481728

Locations

Switzerland
Pfizer Investigational Site
Zurich, Switzerland, CH- 8008

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00481728 History of Changes
Other Study ID Numbers:	A6121189
Study First Received:	June 1, 2007
Last Updated:	May 27, 2009
Health Authority:	Switzerland: Ethikkommission

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Muscarinic Antagonists

Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012