Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05062902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2021-09-16
Brief Title:
A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management
Sponsor:
HillMed Inc
Organization:
HillMed Inc
Study Overview
Official Title:
An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin BoNT injection to treat pelvic floor muscle overactivity that complicates Chronic Pelvic Pain CPP
Detailed Description:
The management of pelvic floor overactivity PFOA using focal BoNT injection has been gaining clinical interest Evidence has shown that BoNT injections to the levator ani in patients with CPP generated a greater than 50 improvement in symptoms at least 72 of the time suggesting a promising efficacy of BoNT therapy The current clinical standard for BoNT injection employs a fixed injection template or the manual palpation of a contracted muscle followed by an injection towards the palpating finger As such the injection is highly subjective operator-dependent variable and not tailored to individual patients which may lead to inconsistent outcomes Trigger point targeted injections have been practiced for many years worldwide yet a recent randomized controlled trial reported no significant difference in outcome between trigger point targeted BoNT injections versus a saline placebo Furthermore it has also been reported that neuromuscular junction NMJ and trigger points are distributed in well-defined separate areas with a distance of approximately 10 mm apart It has also been shown that BoNT injections made 10 mm away from the NMJ can reduce the efficacy of BoNT by 46 Therefore injections targeted at the trigger point may in turn compromise therapeutic efficacy
The rationale of this study is that BoNT acts at the NMJ where the neuromuscular junctions are densely located By specifying the muscles responsible for the pelvic floor overactivity and the offending NMJ using high density surface electromyography HD-sEMG BoNT can be injected with greater accuracy and objectivity to optimize treatment efficacy The investigators aim to test the hypothesis that interstitial cystitis patients in the guided injection arm will demonstrate lower hypertonic metrics and improved quality of life The purpose of this study is to provide preliminary evidence supporting the use of HD-sEMG and NMJ mapping to guide BoNT efficacy
The rationale of this study is that BoNT acts at the NMJ where the neuromuscular junctions are densely located By specifying the muscles responsible for the pelvic floor overactivity and the offending NMJ using high density surface electromyography HD-sEMG BoNT can be injected with greater accuracy and objectivity to optimize treatment efficacy The investigators aim to test the hypothesis that interstitial cystitis patients in the guided injection arm will demonstrate lower hypertonic metrics and improved quality of life The purpose of this study is to provide preliminary evidence supporting the use of HD-sEMG and NMJ mapping to guide BoNT efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None