Overactive BladderNCT02315950
The Use of cineMRI to Evaluate Botox in Patients With Medication Refractory Overactive Bladder
A study testing Botulinum toxin and cineMRI-UDS in people with Overactive Bladder, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
With the goal of providing improved treatment to patients with overactive bladder symptoms (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum toxin on bladder physiology. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Botulinum toxin and cineMRI-UDS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2025
- Phase
- Interventional
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 21 years or older
- Overactive bladder symptoms
Who cannot join
- Age less than 21 years
- Inability to give informed consent
- Claustrophobic
Trial locations and contacts
1 site in 1 country.
Jennifer Anger, MD, MPH contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Jennifer Anger, MD, MPH, 310-385-2992
Jennifer Anger, MD, MPH
About this study
Official title: CineMRI/UDS for Evaluating the Physiologic Effect of Botox in Women With Overactive Bladder
With the goal of providing improved treatment to patients with overactive bladder symptoms (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum toxin on bladder physiology. The investigators will specifically aim to assess the physiological mechanism by which intravesical botulinum alleviates urgency and urge incontinence symptoms in women with OAB refractory to medical therapy.
Read the detailed description
Overactive bladder (OAB) is defined by the International Continence Society as urinary frequency and urgency, with or without urge urinary incontinence. The burden of OAB on the American public is immense in both human and financial terms. Despite this burden, there is a lack of effective diagnostic and treatment modalities for OAB. Other than two-dimensional video urodynamics, which has remained relatively unchanged for decades, there is a lack of diagnostic modalities that will allow investigators to characterize subtypes of OAB and measure the effects of treatment on bladder physiology. Newer imaging techniques are desperately needed to help guide treatment and predict and improve outcomes of different treatment modalities. Intravesical botulinum toxin is a minimally invasive treatment for OAB refractory to medical therapy. Despite the widespread use of intravesical botulinum toxin injection for OAB refractory to medical therapy, to date the optimal placement of the drug has not been determined. Typically ten injections are given, either dispersed evenly across the bladder or in two rows of five injections. However, it remains unknown which injection method will optimize outcomes and reduce the risk of urinary retention after Botox®. This lack of knowledge is a direct result of the fact that there has been no mechanism to study the effect of Botox® on bladder filling and emptying in a three-dimensional fashion. CineMRI-UDS will provide this mechanism, and has the potential to significantly improve care and urologic education by enhancing the understanding of bladder physiology.
- Conditions
- Overactive Bladder
- Being tested
- Botulinum toxin and cineMRI-UDS
- 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.
Botulinum toxin and cineMRI-UDSOther
The investigators will be testing the capability of cineMRI combined with simultaneous urodynamics in the context of OAB in this proposal and expect to reveal a new understanding of diseased lower urinary tract physiology. Participants will receive an injection of intravesical botulinum toxin after filling out validated questionnaires and receiving a pre-treatment cineMRI-UDS.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Botulinum toxin and cineMRI-UDS Receives: Other: Botulinum toxin and cineMRI-UDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-resolved views by CineMRI with urodynamics on overactive bladder physiology
CineMRI and urodynamics technology will be used to obtain time-resolved views of the human bladder during filling and voiding. The investigators aim to reveal a new understanding of diseased lower urinary tract physiology during pre and post treatment.
Measured: About 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer T. Anger, Cedars-Sinai Medical Center
- Investigators
- Jennifer Anger, MD, MPH, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315950
- Sponsor's protocol ID
- Pro00037210
- Status last verified
- Jul 2018
- First submitted
- 28 Oct 2014
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002 Nov;60(5 Suppl 1):7-12; discussion 12. doi: 10.1016/s0090-4295(02)01784-3.
PubMed 12493342Lin K, Bi X, Taimen K, Zuehlsdorff S, Lu B, Carr J, Li D. Coronary wall MR imaging in patients with rapid heart rates: a feasibility study of black-blood steady-state free precession (SSFP). Int J Cardiovasc Imaging. 2012 Mar;28(3):567-75. doi: 10.1007/s10554-011-9852-z. Epub 2011 Apr 2.
PubMed 21461663Zhou X, Rundell V, Liu Y, Tang R, Shah S, Zuehlsdorff S, Li D, Dharmakumar R. On the mechanisms enabling myocardial edema contrast in bSSFP-based imaging approaches. Magn Reson Med. 2011 Jul;66(1):187-91. doi: 10.1002/mrm.22794. Epub 2011 Mar 9.
PubMed 21394764Tsaftaris SA, Tang R, Zhou X, Li D, Dharmakumar R. Ischemic extent as a biomarker for characterizing severity of coronary artery stenosis with blood oxygen-sensitive MRI. J Magn Reson Imaging. 2012 Jun;35(6):1338-48. doi: 10.1002/jmri.23577. Epub 2012 Jan 13.
PubMed 22246681Borghesi G, Simonetti R, Goldman SM, Szejnfeld J, Srougi M, Ortiz V, Bruschini H. Magnetic resonance imaging urodynamics. Technique development and preliminary results. Int Braz J Urol. 2006 May-Jun;32(3):336-41; discussion 341. doi: 10.1590/s1677-55382006000300015.
PubMed 16813681Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.
PubMed 18499184Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, Yan X, Haag-Molkenteller C; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013 Jun;189(6):2186-93. doi: 10.1016/j.juro.2012.12.022. Epub 2012 Dec 14.
PubMed 23246476Anger JT, Weinberg A, Suttorp MJ, Litwin MS, Shekelle PG. Outcomes of intravesical botulinum toxin for idiopathic overactive bladder symptoms: a systematic review of the literature. J Urol. 2010 Jun;183(6):2258-64. doi: 10.1016/j.juro.2010.02.009. Epub 2010 Apr 18.
PubMed 20400142Dmochowski R, Chapple C, Nitti VW, Chancellor M, Everaert K, Thompson C, Daniell G, Zhou J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial. J Urol. 2010 Dec;184(6):2416-22. doi: 10.1016/j.juro.2010.08.021. Epub 2010 Oct 16.
PubMed 20952013Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol. 1996 Jun;77(6):805-12. doi: 10.1046/j.1464-410x.1996.00186.x.
PubMed 8705212Donovan JL, Abrams P, Peters TJ, Kay HE, Reynard J, Chapple C, De La Rosette JJ, Kondo A. The ICS-'BPH' Study: the psychometric validity and reliability of the ICSmale questionnaire. Br J Urol. 1996 Apr;77(4):554-62. doi: 10.1046/j.1464-410x.1996.93013.x.
PubMed 8777617Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601.
PubMed 12206577Chung SD, Liao CH, Chen YC, Kuo HC. Urgency severity scale could predict urodynamic detrusor overactivity in patients with overactive bladder syndrome. Neurourol Urodyn. 2011 Sep;30(7):1300-4. doi: 10.1002/nau.21057. Epub 2011 May 10.
PubMed 21560153
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CineMRI/UDS for Evaluating the Physiologic Effect of Botox in Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT02315950
- Acronym / sponsor ID
- Pro00037210
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Dec 2014 (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.
With the goal of providing improved treatment to patients with overactive bladder symptoms (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum toxin on bladder physiology. The investigators will specifically aim to assess the physiological mechanism by which intravesical botulinum alleviates urgency and urge incontinence symptoms in women with OAB refractory to medical therapy.
Detailed description
Overactive bladder (OAB) is defined by the International Continence Society as urinary frequency and urgency, with or without urge urinary incontinence. The burden of OAB on the American public is immense in both human and financial terms. Despite this burden, there is a lack of effective diagnostic and treatment modalities for OAB. Other than two-dimensional video urodynamics, which has remained relatively unchanged for decades, there is a lack of diagnostic modalities that will allow investigators to characterize subtypes of OAB and measure the effects of treatment on bladder physiology. Newer imaging techniques are desperately needed to help guide treatment and predict and improve outcomes of different treatment modalities. Intravesical botulinum toxin is a minimally invasive treatment for OAB refractory to medical therapy. Despite the widespread use of intravesical botulinum toxin injection for OAB refractory to medical therapy, to date the optimal placement of the drug has not been determined. Typically ten injections are given, either dispersed evenly across the bladder or in two rows of five injections. However, it remains unknown which injection method will optimize outcomes and reduce the risk of urinary retention after Botox®. This lack of knowledge is a direct result of the fact that there has been no mechanism to study the effect of Botox® on bladder filling and emptying in a three-dimensional fashion. CineMRI-UDS will provide this mechanism, and has the potential to significantly improve care and urologic education by enhancing the understanding of bladder physiology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: Botulinum toxin and cineMRI-UDSBotulinum toxin and cineMRI-UDS |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Age 21 years or older
- Overactive bladder symptoms
Key exclusion criteria (3 listed)
- Age less than 21 years
- Inability to give informed consent
- Claustrophobic
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 |
|---|---|---|
| Botulinum toxin and cineMRI-UDSThe investigators will be testing the capability of cineMRI combined with simultaneous urodynamics in the context of OAB in this proposal and expect to reveal a new understanding of diseased lower urinary tract physiology. Participants will receive an injection of intravesical botulinum toxin after filling out validated questionnaires and receiving a pre-treatment cineMRI-UDS. | Other | Arm 1 |
Primary outcome
Time-resolved views by CineMRI with urodynamics on overactive bladder physiology
Time frame: About 10 Months
CineMRI and urodynamics technology will be used to obtain time-resolved views of the human bladder during filling and voiding. The investigators aim to reveal a new understanding of diseased lower urinary tract physiology during pre and post treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 12493342Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002 Nov;60(5 Suppl 1):7-12; discussion 12. doi: 10.1016/s0090-4295(02)01784-3.
- Background: PubMed 21461663Lin K, Bi X, Taimen K, Zuehlsdorff S, Lu B, Carr J, Li D. Coronary wall MR imaging in patients with rapid heart rates: a feasibility study of black-blood steady-state free precession (SSFP). Int J Cardiovasc Imaging. 2012 Mar;28(3):567-75. doi: 10.1007/s10554-011-9852-z. Epub 2011 Apr 2.
- Background: PubMed 21394764Zhou X, Rundell V, Liu Y, Tang R, Shah S, Zuehlsdorff S, Li D, Dharmakumar R. On the mechanisms enabling myocardial edema contrast in bSSFP-based imaging approaches. Magn Reson Med. 2011 Jul;66(1):187-91. doi: 10.1002/mrm.22794. Epub 2011 Mar 9.
- Background: PubMed 22246681Tsaftaris SA, Tang R, Zhou X, Li D, Dharmakumar R. Ischemic extent as a biomarker for characterizing severity of coronary artery stenosis with blood oxygen-sensitive MRI. J Magn Reson Imaging. 2012 Jun;35(6):1338-48. doi: 10.1002/jmri.23577. Epub 2012 Jan 13.
- Background: PubMed 16813681Borghesi G, Simonetti R, Goldman SM, Szejnfeld J, Srougi M, Ortiz V, Bruschini H. Magnetic resonance imaging urodynamics. Technique development and preliminary results. Int Braz J Urol. 2006 May-Jun;32(3):336-41; discussion 341. doi: 10.1590/s1677-55382006000300015.
- Background: PubMed 18499184Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.
- Background: PubMed 23246476Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, Yan X, Haag-Molkenteller C; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013 Jun;189(6):2186-93. doi: 10.1016/j.juro.2012.12.022. Epub 2012 Dec 14.
- Background: PubMed 20400142Anger JT, Weinberg A, Suttorp MJ, Litwin MS, Shekelle PG. Outcomes of intravesical botulinum toxin for idiopathic overactive bladder symptoms: a systematic review of the literature. J Urol. 2010 Jun;183(6):2258-64. doi: 10.1016/j.juro.2010.02.009. Epub 2010 Apr 18.
- Background: PubMed 20952013Dmochowski R, Chapple C, Nitti VW, Chancellor M, Everaert K, Thompson C, Daniell G, Zhou J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial. J Urol. 2010 Dec;184(6):2416-22. doi: 10.1016/j.juro.2010.08.021. Epub 2010 Oct 16.
- Background: PubMed 8705212Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol. 1996 Jun;77(6):805-12. doi: 10.1046/j.1464-410x.1996.00186.x.
- Background: PubMed 8777617Donovan JL, Abrams P, Peters TJ, Kay HE, Reynard J, Chapple C, De La Rosette JJ, Kondo A. The ICS-'BPH' Study: the psychometric validity and reliability of the ICSmale questionnaire. Br J Urol. 1996 Apr;77(4):554-62. doi: 10.1046/j.1464-410x.1996.93013.x.
- Background: PubMed 12206577Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601.
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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.
Jennifer Anger, MD, MPH contact
Jennifer Anger, MD, MPH principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin and cineMRI-UDS in people with Overactive Bladder, run by Cedars-Sinai Medical Center 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Anger, MD, MPH (3103852992), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-resolved views by CineMRI with urodynamics on overactive bladder physiology (time frame: About 10 Months). 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 NCT02315950, which also lists 13 linked publications.
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 18 Jul 2018.