Overactive BladderNCT01739946
Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.
An observational study of Overactive Bladder, run by Michael Chancellor, MD at 1 site in United States.
Trial summary
The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Overactive Bladder
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2016
- Phase
- Observational
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with either have OAB and will be undergoing an InterStim® implant (InterStim® group) or do not have bladder symptoms or an InterStim® device (Control group)
Who may be able to join
- Female
- Age 18-75 years
- Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit.
- At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary.
- InterStim® treatment naïve or being revised with a new lead
- Female
Show all 9Show fewer
- Age 18-75 years
- Deny history of OAB diagnosis or symptoms (urgency and frequency with or without urge incontinence)
- American Urological Association (AUA) symptom score of ≤4
Who cannot join
- Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review
- Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I)
- Revision of only the IPG (without replacement of the tined lead)
- More than one InterStim® device being placed (undergoing bilateral stimulation)
- Controls (n=10)
- -History of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.
Read the detailed description
This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.
- Conditions
- Overactive Bladder
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Implanted subject | Subjects with Interstim implanted | |
| Controls | Subjects without Interstim implanted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve Growth Factor (NGF) levels
pg/ml
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Chancellor, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health East
- Responsible party
- Sponsor-investigator, Michael Chancellor, MD, Corewell Health East
- Investigators
- Michael Chancellor, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739946
- Sponsor's protocol ID
- 2012-143
- Status last verified
- Jul 2017
- First submitted
- 28 Nov 2012
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share individual participant data
Publications
Peters KM, Jayabalan N, Bui D, Killinger K, Chancellor M, Tyagi P. Effect of Sacral Neuromodulation on Outcome Measures and Urine Chemokines in Interstitial Cystitis/Painful Bladder Syndrome Patients. Low Urin Tract Symptoms. 2015 May;7(2):77-83. doi: 10.1111/luts.12054. Epub 2014 Mar 17.
PubMed 26663686
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.
- ClinicalTrials.gov ID
- NCT01739946
- Acronym / sponsor ID
- 2012-143
- Conditions
- Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Michael Chancellor, MDUniversity, hospital or other
- Collaborators
- Corewell Health East
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Dec 2012 (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.
The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.
Detailed description
This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implanted subject | – | –Subjects with Interstim implanted |
| Controls | – | –Subjects without Interstim implanted |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with either have OAB and will be undergoing an InterStim® implant (InterStim® group) or do not have bladder symptoms or an InterStim® device (Control group)
Key inclusion criteria (9 listed)
- Female
- Age 18-75 years
- Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit.
- At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary.
- InterStim® treatment naïve or being revised with a new lead
Key exclusion criteria (6 listed)
- Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review
- Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I)
- Revision of only the IPG (without replacement of the tined lead)
- More than one InterStim® device being placed (undergoing bilateral stimulation)
- Controls (n=10)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nerve Growth Factor (NGF) levels
Time frame: 4 weeks
pg/ml
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 1 Aug 2017.
- Derived from this study: PubMed 26663686Peters KM, Jayabalan N, Bui D, Killinger K, Chancellor M, Tyagi P. Effect of Sacral Neuromodulation on Outcome Measures and Urine Chemokines in Interstitial Cystitis/Painful Bladder Syndrome Patients. Low Urin Tract Symptoms. 2015 May;7(2):77-83. doi: 10.1111/luts.12054. Epub 2014 Mar 17.
- Individual participant dataSharing planned: No. No plan to share individual participant data
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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.
Michael Chancellor, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Michael Chancellor, MD at 1 site in United States.
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 9 inclusion and 6 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 1 Aug 2017. 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 United States. 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.
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?
Nerve Growth Factor (NGF) levels (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739946, which also lists 1 linked publication.
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 1 Aug 2017.