Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425575
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-02-21
Brief Title:
Resolution of Pudendal Neuralgia in Chronic Pelvic Pain Using a Novel Biologic Therapy
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Resolution of Pudendal Neuralgia in Chronic Pelvic Pain Using a Novel Biologic Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
This goal of this study is to determine whether a novel biologic ie an amniotic suspension allograft ASA will reduce pain and improve quality of life QoL in women stricken with chronic pelvic pain CPP The main questions it aims to answer are
Weather pain in the genitalia is reduced with treatment
Weather bladder or urination pain is reduced with treatment
Weather any adverse events occur following treatment Patient responses to pain and QoL will be collected before and 6-12 months after treatment
Weather pain in the genitalia is reduced with treatment
Weather bladder or urination pain is reduced with treatment
Weather any adverse events occur following treatment Patient responses to pain and QoL will be collected before and 6-12 months after treatment
Detailed Description:
This is an observational study and is driven by the hypothesis that novel biologic ie an amniotic suspension allograft ASA will reduce pain and improve quality of life in women stricken with chronic pelvic pain CPP This clinical trial is performed in a hospital-based practice at Thomas Jefferson University in which all patients over the age of 18 presenting with clinically defined CPP will be accepted into the study and therefore all patients will be treated with the ASA no patients with CPP will be excluded from the study This small study is not funded so the patients will not be randomized and there will not be any control subjects receiving placebo instead of the ASA product Upon arriving to the hospital but just prior to treatment all patients will be asked to fill out a consent form and a pre-procedure questionnaire regarding pain discomfort and quality of life issues theyve been experiencing prior to treatment They will then be brought into the operating room placed in the lithotomy position and briefly anesthetized 15-30 min Once anesthetized the urogynecologist will feel for an opening in the pelvic bone ischium by inserting her fingers into the vagina The opening Alcocks canal in the ischium exposes the pudendal nerve which carries pain signals from the vagina and nearby tissues to the brains pain centers Once the medial aspect of Alcocks canal is clearly identified by the doctors fingers a 6 inch pudendal trumpet needle will be advanced through the vaginal wall and guided and placed near the pudendal nerve in Alcocks canal A solution of the ASA along with sterile saline and the anesthetic marcaine 5 cc total will be injected so as to infiltrate the pudendal nerve with this mixture Marcaine is used to help suppress any acute pain that may occur in the few hours after treatment Both the left and right pudendal nerves will be thusly treated When the patients awaken they will receive a drink of choice and light snack like gram crackers or biscuits When fully awake the patients will be allowed to leave the hospital accompanied with a companion but not allowed to drive until the full effects of the anesthesia has worn off several hours later From beginning to end this procedure takes approximately one hour To determine the extent to which any pain relief and quality of life have improved or not answers to a follow-up questionnaire will be solicited from each participating patient by telephone approximately 6 to 12 months after treatment The questionnaire contains 14 questions addressing pain and discomfort urination and impact of symptoms and takes about 10 minutes to compete To protect patient privacy the data will be entered into an Excel spreadsheet with the patients names replaced by a number and date of birth replaced with just their age The data will be digitized analyzed and statistical significance will be evaluated buy a biostatistician This study has been approved by the institutional review board protocol number 18D719 prior to beginning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None