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

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ClinicalTrials.gov Identifier: NCT02315950
Recruitment Status : Recruiting
First Posted : December 12, 2014
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer T. Anger, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Other: Botulinum toxin and cineMRI-UDS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: CineMRI/UDS for Evaluating the Physiologic Effect of Botox in Women With Overactive Bladder
Study Start Date : December 2014
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Arm 1
Botulinum toxin and cineMRI-UDS
Other: Botulinum toxin and cineMRI-UDS
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 Measures :
  1. 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.


Other Outcome Measures:
  1. Improvement in overactive bladder symptoms by smooth muscle paralysis via botulinum toxin injection (100U) [ Time Frame: About 10 Months ]
    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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315950


Contacts
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Contact: Jennifer Anger, MD, MPH 3103852992

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Jennifer Anger, MD, MPH    310-385-2992      
Principal Investigator: Jennifer Anger, MD, MPH         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Jennifer Anger, MD, MPH Cedars-Sinai Medical Center

Publications:

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Responsible Party: Jennifer T. Anger, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02315950     History of Changes
Other Study ID Numbers: Pro00037210
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs