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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Zurich, , CH- 8008 Switzerland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Female, healthy volunteers or OAB patients 18-65 years old, non pregnant and non
lactating

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00481728
Pfizer
Completed
Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.

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Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Overactive Bladder
  • Drug: Tolterodine
    Single dose per patient as determined by protocol.
  • Procedure: Filling cystometry
    This is a procedure.
  • Procedure: Intravesical neurostimulation
    This is a procedure.
Experimental: Tolterodine
Interventions:
  • Drug: Tolterodine
  • Procedure: Filling cystometry
  • Procedure: Intravesical neurostimulation
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00481728
A6121189
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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