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

Phase 1

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Tolterodine; Procedure: Filling cystometry; Procedure: Intravesical neurostimulation

• Registration Number: NCT00481728
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-01
• Study First Submitted QC: 2007-06-01
• Study First Posted: 2007-06-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tolterodine	Intravesical neurostimulation	-
Tolterodine	Filling cystometry	-
Tolterodine	Tolterodine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇭 Zurich, Switzerland