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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02619721 -
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
|
Phase 0 | |
| Completed |
NCT01525485 -
Vaginal Electrical Stimulation Versus Neuromodulation
|
N/A |