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

Early Phase 1

• Conditions: Refractory Overactive Bladder
• Interventions: Device: PINS SNS

• Registration Number: NCT02619721
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-10-08
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-11
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacral Neuromodulation is off	PINS SNS	Sacral Neuromodulation is off after implantation
Sacral Neuromodulation is on	PINS SNS	Sacral Neuromodulation is on as soon as implantation

Primary Outcome Measures

Name	Time	Method
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month	6 month of stimulation

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China