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

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.

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

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 neurostimulation in healthy volunteers and OAB patients

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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

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

Study ID Number: A6121189

ClinicalTrials.gov Identifier: NCT00481728

Health Authority: Switzerland: Ethikkommission

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