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

Evaluation of Sympathetic Skin Responses and Heart Rate Variability as Objective Measures of Bladder Sensation - a Double Blind Third Party Open Placebo Controlled Randomised Study Using a Single Dose of Tolterodine in Patients With Idiopathic Overactive Bladder and Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00481728

Enrollment

Registered

2007-06-04

Start date

2007-06-30

Completion date

2008-12-31

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

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.

Interventions

DRUGTolterodine

Single dose per patient as determined by protocol.

PROCEDUREFilling cystometry

This is a procedure.

PROCEDUREIntravesical neurostimulation

This is a procedure.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026