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”

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.

Study Type: Interventional

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

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Tolterodine

Primary Measures

• Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimultion in healthy volunteers and OAB patients
  • Time Frame: Duration of study.
    Safety Issue?: No

Secondary 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
    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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00481728

Study ID Number: A6121189

ClinicalTrials.gov Identifier: NCT00481728

Health Authority: Switzerland: Ethikkommision

To obtain contact information for a study center near you, click here.