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

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

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.

Study Overview

• Status: Unknown
• Conditions: Refractory Overactive Bladder
• Intervention / Treatment: Procedure: ultrasound; Procedure: X-ray

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: US group; lead implantation surgery for SNM using ultrasound guided technique	Procedure: ultrasound; Lead implantation surgery for SNM using ultrasound guided technique
SHAM_COMPARATOR: X-ray group; lead implantation surgery for SNM using X-ray guided technique	Procedure: X-ray; Lead implantation surgery for SNM using X-ray technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful rate	Successful rate is the percentage of patients who experienced a successful result (≥50% improvements in baseline symptoms ) as recorded in voiding dairies.	6 months post -IPG implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse effect	During operation, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
Guidance technique performance time	From beginning operation until successful lead placement is completed
Times of X-ray radiation	During operation
Overactive bladder symptom score (OABSS)	pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
Quality of Life (QoL) scores	pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation

Collaborators and Investigators

• Sponsor: Beijing Pins Medical Co., Ltd

Study record dates

Study Major Dates

• Study Start: February 1, 2017
• Primary Completion (ANTICIPATED): August 1, 2018
• Study Completion (ANTICIPATED): February 1, 2019

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (ESTIMATE): October 27, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: PINS-022