NCT02315950

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

CineMRI/UDS for Evaluating the Physiologic Effect of Botox in Women With Overactive Bladder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2014-12-12
• Last updated: 2018-07-18

Locations

1 site across 1 country: United States