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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country28 target enrollmentJune 2007

ConditionsOveractive Bladder

InterventionsTolterodine Filling cystometry Intravesical neurostimulation

DrugsTolterodine

Overview

Phase: Phase 1
Intervention: Tolterodine
Conditions: Overactive Bladder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 28
Locations: 1
Primary Endpoint: Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

December 2008

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Eligibility 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

Arms & Interventions

Tolterodine

Intervention: Tolterodine

Tolterodine

Intervention: Filling cystometry

Tolterodine

Intervention: Intravesical neurostimulation

Outcomes

Primary Outcomes

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 Outcomes

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.(duration of study)
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.(duration of study)