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

Sponsored by:	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

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
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

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
Tolterodine: Experimental	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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6121189
Study First Received:	June 1, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00481728 History of Changes
Health Authority:	Switzerland: Ethikkommission

Study placed in the following topic categories:

Muscarinic Antagonists
Signs and Symptoms
Urinary Bladder, Overactive
Neurotransmitter Agents
Cystocele
Cholinergic Antagonists

Urologic Diseases
Urinary Bladder Diseases
Healthy
Cholinergic Agents
Tolterodine

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Tolterodine

ClinicalTrials.gov processed this record on May 07, 2009