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

NCT ID: NCT02619721

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-02-28

Brief Summary

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

Detailed Description

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Conditions

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Refractory Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sacral Neuromodulation is on

Sacral Neuromodulation is on as soon as implantation

Group Type EXPERIMENTAL

PINS SNS

Intervention Type DEVICE

Sacral Neuromodulation is off

Sacral Neuromodulation is off after implantation

Group Type PLACEBO_COMPARATOR

PINS SNS

Intervention Type DEVICE

Interventions

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PINS SNS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PINS-016

Identifier Type: -

Identifier Source: org_study_id

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