Overactive BladderPhase 1NCT00481728
Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.
A Phase 1 study testing Tolterodine, Filling cystometry and Intravesical neurostimulation in people with Overactive Bladder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Tolterodine, Filling cystometry and Intravesical neurostimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2007to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, healthy volunteers or OAB patients 18-65 years old, non pregnant and non lactating
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Evaluation of the link between bladder sensation and changes in skin electrical conductance and heart rate.
- Conditions
- Overactive Bladder
- Being tested
- Tolterodine, Filling cystometry, Intravesical neurostimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolterodineDrug
Single dose per patient as determined by protocol.
Filling cystometryProcedure or surgery
This is a procedure.
Intravesical neurostimulationProcedure or surgery
This is a procedure.
| Study group | Role | What they receive |
|---|---|---|
| Tolterodine | Experimental | Not described Receives: Drug: Tolterodine; Procedure: Filling cystometry; Procedure: Intravesical neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481728
- Sponsor's protocol ID
- A6121189
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2007
- Last updated
- 27 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00481728
- Acronym / sponsor ID
- A6121189
- Conditions
- Overactive Bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolterodine | Experimental | Drug: Tolterodine, Procedure: Filling cystometry, Procedure: Intravesical neurostimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female, healthy volunteers or OAB patients 18-65 years old, non pregnant and non lactating
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolterodineSingle dose per patient as determined by protocol. | Drug | Tolterodine |
| Filling cystometryThis is a procedure. | Procedure or surgery | Tolterodine |
| Intravesical neurostimulationThis is a procedure. | Procedure or surgery | Tolterodine |
Primary outcome
Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients
2 secondary outcomes
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.
Time frame: 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.
Time frame: duration of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tolterodine, Filling cystometry and Intravesical neurostimulation in people with Overactive Bladder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.