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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00481728
First Posted: June 4, 2007
Last Update Posted: May 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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:


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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00481728     History of Changes
Other Study ID Numbers: A6121189
First Submitted: June 1, 2007
First Posted: June 4, 2007
Last Update Posted: May 28, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents