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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: June 1, 2007
Last updated: May 27, 2009
Last verified: May 2009
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
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:

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Pfizer Investigational Site
Zurich, Switzerland, CH- 8008
Sponsors and Collaborators
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 
Study First Received: June 1, 2007
Last Updated: May 27, 2009
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on May 05, 2016