Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00481728
First received: June 1, 2007
Last updated: May 27, 2009
Last verified: May 2009
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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 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.
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 More Information
Additional Information:
No publications provided
| 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 Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Tolterodine Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013