IVES for Treatment of UUI and OAB

Loma Linda University (LLU)

Status and phase: Completed; Early Phase 1

Conditions: Urinary Bladder, Overactive; Urinary Incontinence, Urge

Treatments: Device: EMED detruset(TM) intravesical electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02992509

5130321

Details and patient eligibility

About

The pilot study is intended to show the efficacy of intravesical electrical stimulation in treating overactive bladder with or without frequency and/or urgency urinary incontinence.

Full description

The EMED Technologies detrusetTM intravesical electrical stimulation (IVES) catheter is indicated for use with the EMED detrusanTM 500 electrical generator for the treatment of overactive bladder and urge urinary incontinence (UI) in women who are not satisfied with or cannot tolerate other conservative treatments. EMED is interested in conducting a prospective randomized multi-center study of IVES therapy vs conventional UI treatments. In order to gain sufficient knowledge of the treatment effect and variability of IVES therapy to power an RCT, a pilot study will be initially conducted.

The pilot study is intended to show the efficacy of IVES in treating overactive bladder with or without frequency and/or urgency urinary incontinence with safety profile of IVES being no worse than with standard urological catheters.

A primary endpoint at 3 months showing reduction in incontinence events via a 7-level patient global impression of improvement will be established. Secondary endpoints will include PCI for subsets of symptoms, 3 day voiding diary, and patient satisfaction questionnaires.

Follow up at end of therapy and 3 months from the first therapy session will be conducted. 6-month, 9-month, and 12-month follow up can be conducted to establish durability of IVES therapy if it is found to be effective at 3 months after the first treatment

Enrollment: 17 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• 18-90 years old
• Urinary urge incontinence OR overactive bladder
• Prior trial of medical treatment for UUI or OAB

Exclusion criteria

• pelvic organ prolapse greater than stage 1
• multiple sclerosis
• parkinson's disease
• spinal cord injury
• long-term DM type I
• prior surgeries that may affect innervation of the detrusor nerves or the spinal cord
• pregnancy
• pacemaker/defibrillator
• PVR >150ml
• dementia
• Stress urinary incontinence
• intravesical botox injection within 1 year, PTNS within 6 months, or medical treatment for OAB within 3 weeks; bulking agent injection within 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Treatment

Other group

Description:

This pilot study group is a prospective observational study. It is not blinded and there is no control. This is a single arm study (treatment group) which will receive intravesical electrical stimulation with a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks.

Treatment:

Device: EMED detruset(TM) intravesical electrical stimulation