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

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Viatris

Status and phase

Completed
Phase 1

Conditions

Overactive Bladder

Treatments

Drug: Tolterodine
Procedure: Intravesical neurostimulation
Procedure: Filling cystometry

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

28 participants in 1 patient group

Tolterodine
Experimental group
Treatment:
Procedure: Filling cystometry
Procedure: Intravesical neurostimulation
Drug: Tolterodine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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