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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Tolterodine
Filling cystometry
Intravesical neurostimulation
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overactive Bladder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tolterodine

Arm Description

Outcomes

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.
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.

Full Information

First Posted
June 1, 2007
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00481728
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tolterodine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tolterodine
Intervention Description
Single dose per patient as determined by protocol.
Intervention Type
Procedure
Intervention Name(s)
Filling cystometry
Intervention Description
This is a procedure.
Intervention Type
Procedure
Intervention Name(s)
Intravesical neurostimulation
Intervention Description
This is a procedure.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Zurich
ZIP/Postal Code
CH- 8008
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6121189&StudyName=Evaluation%20of%20the%20link%20between%20bladder%20sensation%20and%20changes%20in%20skin%20electrical%20conductance%20and%20heart%20rate.
Description
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Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.

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