Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00481728
Collaborator
(none)
28
1
1
18
1.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Evaluation of the link between bladder sensation and changes in skin electrical conductance and heart rate.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
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
Study Start Date
:
Jun 1, 2007
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tolterodine
|
Drug: Tolterodine
Single dose per patient as determined by protocol.
Procedure: Filling cystometry
This is a procedure.
Procedure: Intravesical neurostimulation
This is a procedure.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
Female
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Zurich | Switzerland | CH- 8008 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00481728
Other Study ID Numbers:
- A6121189
First Posted:
Jun 4, 2007
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021