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A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB) With X-Ray Guided Technique

NCT ID: NCT02946723

Last Updated: 2016-10-27

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

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2019-02-28

Brief Summary

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Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The SNM treatment involves a two-stage surgical procedure performed under local anesthesia. The device include IPG (implantable programme generator) and lead. In the initial test phase, 1st stage, electrode is placed near the sacral nerve and requires a 2 weeks assessment. This allows your doctors and you to assess your initial response according to your voiding dairy and satisfaction. In 2nd stage, SNM procedure is implantation of the IPG.

X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real time visual guidance ,easy to operate by doctors and a radiation free option to challenge anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and dedicating to developing better guidance technique in surgery.

The study here compare the efficacy and safety of ultrasound versus X ray guidance technique in SNM.

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

DOUBLE

Participants Outcome Assessors

Study Groups

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US group

lead implantation surgery for SNM using ultrasound guided technique

Group Type EXPERIMENTAL

ultrasound

Intervention Type PROCEDURE

Lead implantation surgery for SNM using ultrasound guided technique

X-ray group

lead implantation surgery for SNM using X-ray guided technique

Group Type SHAM_COMPARATOR

X-ray

Intervention Type PROCEDURE

Lead implantation surgery for SNM using X-ray technique

Interventions

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ultrasound

Lead implantation surgery for SNM using ultrasound guided technique

Intervention Type PROCEDURE

X-ray

Lead implantation surgery for SNM using X-ray technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age \> 16 years;
2. Subjects suitable for SNM surgery;
3. Normal upper urinary tract function;
4. Bladder volume \> 100 mL;
5. Good compliance and able to complete the follow-up assessments.

Exclusion Criteria

1. Psychiatric or neurologic disabilities on neurologic evaluation such as multiple sclerosis, spinal cord injury, epilepsy, Parkinson's disease, stroke;
2. Bladder lithiasis or tumor (cystoscopy or ultrasonography);
3. Stress urinary incontinence;
4. Bladder outlet obstruction;
5. Diuresis \> 3 liters per 24 hours;
6. Negative at the test period or previous treatment with SNM;
7. Pregnancy and plan to be pregnancy in 2 years.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Fumin Jia, PhD

Role: CONTACT

Phone: 010-59361265

Email: [email protected]

Luming Li

Role: CONTACT

Phone: 010-60736388

Other Identifiers

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PINS-022

Identifier Type: -

Identifier Source: org_study_id