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

NCT00481728 | Completed Phase 1

• 1 other identifier: A6121189
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• 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

Study Arms (1)

Tolterodine

EXPERIMENTAL

Drug: Tolterodine; Procedure: Filling cystometry; Procedure: Intravesical neurostimulation

Interventions

Tolterodine DRUG

Single dose per patient as determined by protocol.

Tolterodine

Filling cystometry PROCEDURE

This is a procedure.

Tolterodine

Intravesical neurostimulation PROCEDURE

This is a procedure.

Tolterodine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Pfizer Investigational Site

Zurich, CH- 8008, Switzerland

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 4, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

CH (1)