Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02946723
Status:
UNKNOWN
Last Update Posted:
2016-10-27
First Post:
2016-10-25
Brief 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
Sponsor:
Beijing Pins Medical Co Ltd
Organization:
Beijing Pins Medical Co Ltd
Study Overview
Official Title:
A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation SNM in Subjects With Overactive Bladder OABWith X-Ray Guided Technique
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Overactive bladderOABUrgency 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 pathologyThe 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None