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

Not Applicable

Recruiting

• Conditions: Overactive Bladder
• Interventions: Other: Botulinum toxin and cineMRI-UDS

• Registration Number: NCT02315950
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-10-28
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Botulinum toxin and cineMRI-UDS	Botulinum toxin and cineMRI-UDS

Primary Outcome Measures

Name	Time	Method
Time-resolved views by CineMRI with urodynamics on overactive bladder physiology	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.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Beverly Hills, California, United States