search
Back to results

The Use of cineMRI to Evaluate Botox in Patients With Medication Refractory Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin and cineMRI-UDS
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overactive Bladder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • Age 21 years or older
  • Overactive bladder symptoms

Exclusion Criteria:

  • Age less than 21 years
  • Inability to give informed consent
  • Claustrophobic

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Botulinum toxin and cineMRI-UDS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2014
Last Updated
July 17, 2018
Sponsor
Cedars-Sinai Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02315950
Brief Title
The Use of cineMRI to Evaluate Botox in Patients With Medication Refractory Overactive Bladder
Official Title
CineMRI/UDS for Evaluating the Physiologic Effect of Botox in Women With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Botulinum toxin and cineMRI-UDS
Intervention Type
Other
Intervention Name(s)
Botulinum toxin and cineMRI-UDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time-resolved views by CineMRI with urodynamics on overactive bladder physiology
Description
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.
Time Frame
About 10 Months
Other Pre-specified Outcome Measures:
Title
Improvement in overactive bladder symptoms by smooth muscle paralysis via botulinum toxin injection (100U)
Description
This injection is performed under local anesthesia in the office. 100U of botulinum toxin (Botox ®) will be mixed under sterile conditions with 10cc of sterile saline and injected into 10 discrete locations in the bladder. Participants will be asked to fill out questionnaires for the management of clinical and statistical measures.
Time Frame
About 10 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Age 21 years or older Overactive bladder symptoms Exclusion Criteria: Age less than 21 years Inability to give informed consent Claustrophobic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Anger, MD, MPH
Phone
3103852992
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Anger, MD, MPH
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Anger, MD, MPH
Phone
310-385-2992
First Name & Middle Initial & Last Name & Degree
Jennifer Anger, MD, MPH

12. IPD Sharing Statement

Citations:
PubMed Identifier
12493342
Citation
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.
Results Reference
background
PubMed Identifier
21461663
Citation
Lin 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.
Results Reference
background
PubMed Identifier
21394764
Citation
Zhou 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.
Results Reference
background
PubMed Identifier
22246681
Citation
Tsaftaris 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.
Results Reference
background
PubMed Identifier
16813681
Citation
Borghesi 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.
Results Reference
background
PubMed Identifier
18499184
Citation
Brubaker 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.
Results Reference
background
PubMed Identifier
23246476
Citation
Nitti 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.
Results Reference
background
PubMed Identifier
20400142
Citation
Anger 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.
Results Reference
background
PubMed Identifier
20952013
Citation
Dmochowski 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.
Results Reference
background
PubMed Identifier
8705212
Citation
Jackson 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.
Results Reference
background
PubMed Identifier
8777617
Citation
Donovan 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.
Results Reference
background
PubMed Identifier
12206577
Citation
Coyne 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.
Results Reference
background
PubMed Identifier
21560153
Citation
Chung 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.
Results Reference
background

Learn more about this trial

The Use of cineMRI to Evaluate Botox in Patients With Medication Refractory Overactive Bladder

We'll reach out to this number within 24 hrs