Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150599
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-11-20
Brief Title:
Sacral Neuromodulation for Chronic Pelvic Pain
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
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:
SNM_CPP
Brief Summary:
Sacral neuromodulation SNM is a safe effective and minimally invasive FDA approved treatment for urinary and fecal incontinence urinary frequency urgency and urinary retention In this study we are assessing the effectiveness of sacral neuromodulation in women with suffering from chronic pelvic pain CPP through a single device implant procedure
Detailed Description:
Despite SNM being available for more than 25 years there are many things about this technology that remain elusive Enhancing our understanding of SNM in the chronic pelvic pain CPP population can rapidly improve the care of current patients suffering from pelvic pain as well as help develop future technologies stimulation paradigms and lead to effective counseling of patients CPP is one of most common and challenging conditions for clinicians to treat today CPP is defined as nonmalignant persistent pain perceived in structures or organs of the pelvis for at least 6 months As such CPP can be caused by numerous underlying conditions from gynecological eg endometriosis gastrointestinal eg celiac disease irritable bowel syndrome urological eg interstitial cystitis musculoskeletal eg fibromyalgia prostatitis and neurologicalvascular eg spinal cord injury ilioinguinal nerve entrapment origin From a urological perspective the pain in CPP syndrome can be associated with symptoms suggesting urinary sexual or bowel dysfunction and are commonly associated with Overactive Bladder OAB symptoms of urinary frequency urgency and incontinence CPP has a debilitating effect on quality of life leading to other comorbidities such as depression anxiety and sleep disorders CPP is common in both men and women but occurs more frequently in women This study will assess the effectiveness of sacral neuromodulation in women
This is a prospective single arm and single blinded quasi-placebo controlled study Patients will be blinded to the device settings For those that qualify the sacral neuromodulation device will be placed by an experienced physician After placement in the operating room the device settings will be adjusted 2 weeks post-operatively participants return and complete study questionnaires The devices settings will again be adjusted at this visit The device may turned onoff or settings modified throughout the study To maintain study integrity patients will not be informed how device settings are changed At each follow up visit participants will be asked to complete study questionnaires and will have their device settings adjusted Participants will follow up over a course of 12 months from the time of device implantation
This is a prospective single arm and single blinded quasi-placebo controlled study Patients will be blinded to the device settings For those that qualify the sacral neuromodulation device will be placed by an experienced physician After placement in the operating room the device settings will be adjusted 2 weeks post-operatively participants return and complete study questionnaires The devices settings will again be adjusted at this visit The device may turned onoff or settings modified throughout the study To maintain study integrity patients will not be informed how device settings are changed At each follow up visit participants will be asked to complete study questionnaires and will have their device settings adjusted Participants will follow up over a course of 12 months from the time of device implantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None