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

Viatris

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00481728

A6121189

Details and patient eligibility

About

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.

Full description

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

Enrollment: 28 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 1 patient group

Tolterodine

Experimental group

Treatment:

Drug: Tolterodine

Procedure: Filling cystometry

Procedure: Intravesical neurostimulation