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

Refractory Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02946723
• Other study ID #: PINS-022
• Status: Not yet recruiting
• Phase: Phase 1
• First received: October 25, 2016
• Last updated: October 25, 2016
• Start date: February 2017
• Est. completion date: February 2019

Study information

• Verified date: October 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Fumin Jia, PhD
• Phone: 010-59361265
• Email: pins_medical[@]163.con
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractory Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Procedure:
• ultrasound
Lead implantation surgery for SNM using ultrasound guided technique
• X-ray
Lead implantation surgery for SNM using X-ray technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse effect		During operation, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation	Yes
Secondary	Guidance technique performance time		From beginning operation until successful lead placement is completed	No
Secondary	Times of X-ray radiation		During operation	No
Secondary	Overactive bladder symptom score (OABSS)		pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation	No
Secondary	Quality of Life (QoL) scores		pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation	No