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
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Other: Botulinum toxin and cineMRI-UDS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|Contact: Jennifer Anger, MD, MPH||3103852992|
|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|
|Principal Investigator:||Jennifer Anger, MD, MPH||Cedars-Sinai Medical Center|