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

NCT ID: NCT00481728

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-12-31

Brief Summary

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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

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

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tolterodine

Group Type EXPERIMENTAL

Tolterodine

Intervention Type DRUG

Single dose per patient as determined by protocol.

Filling cystometry

Intervention Type PROCEDURE

This is a procedure.

Intravesical neurostimulation

Intervention Type PROCEDURE

This is a procedure.

Interventions

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Tolterodine

Single dose per patient as determined by protocol.

Intervention Type DRUG

Filling cystometry

This is a procedure.

Intervention Type PROCEDURE

Intravesical neurostimulation

This is a procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Related Links

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Other Identifiers

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A6121189

Identifier Type: -

Identifier Source: org_study_id

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