Recruiting

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

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT02315950

Conditions

Overactive Bladder

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Botulinum toxin and cineMRI-UDS

Study Details

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.

Conditions

Overactive Bladder

Study ID

NCT02315950

Start date

Dec, 2014

Status verified date

Jul, 2018

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Arm 1

Botulinum toxin and cineMRI-UDS

Interventions

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 measure

Time-resolved views by CineMRI with urodynamics on overactive bladder physiology [ Time Frame: About 10 Months ]

Central Contacts and Locations

Central contacts

Jennifer Anger, MD, MPH

3103852992

Locations

Cedars-Sinai Medical Center

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Jennifer Anger, MD, MPH

310-385-2992

Principal Investigator:

Jennifer Anger, MD, MPH

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Jul 18, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2018-07-18.