Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)

Beijing Pins Medical

Status and phase: Unknown; Early Phase 1

Conditions: Refractory Overactive Bladder

Treatments: Device: PINS SNS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02619721

PINS-016

Details and patient eligibility

About

Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.

Enrollment: 7 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 16 years OAB and/or OAB symptoms Refractory to standard medical therapy 100ml bladder capacity with normal upper urinary tract Good surgical candidate Able to complete study documentation and return for followup evaluation

Exclusion criteria

• Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 2 patient groups, including a placebo group

Sacral Neuromodulation is on

Experimental group

Description:

Sacral Neuromodulation is on as soon as implantation

Treatment:

Device: PINS SNS

Sacral Neuromodulation is off

Placebo Comparator group

Description:

Sacral Neuromodulation is off after implantation

Treatment:

Device: PINS SNS