Clinical trial NCT06425575: Resolution of Pudendal Neuralgia in Chronic Pelvic Pain Using a Novel Biologic Therapy
Official title: Resolution of Pudendal Neuralgia in Chronic Pelvic Pain Using a Novel Biologic Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pelvic Pain Syndrome
Keywords: pudendal neuralgia
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: The Cooper Health System
First posted: 2024-05-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women presenting with chronic pelvic pain who are over 18 and without terminal disease

Brief summary: This goal of this study is to determine whether a novel biologic, i.e., 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.

Detailed description: This is an observational study and is driven by the hypothesis that novel biologic, i.e., 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 they've 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 (Alcock's canal) in the ischium exposes the pudendal nerve which carries pain signals from the vagina and nearby tissues to the brain's pain centers. Once the medial aspect of Alcock's canal is clearly identified by the doctor's fingers, a 6 inch pudendal trumpet needle will be advanced through the vaginal wall and guided and placed near the pudendal nerve in Alcock's 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: 18D.719) prior to beginning.

Eligibility criteria: Inclusion Criteria: All patients 18 years of age or older who present with chronic pelvic pain -

Exclusion Criteria:

1. Under 18 years of age
2. Malignancy defined as terminal -

Primary outcomes:
measure: Overall Pain and overall quality of life
timeFrame: Between 6 and 12 months after treatment
Secondary outcomes:
measure: Bladder pain and urination frequency
timeFrame: Between 6 and 12 months after treatment
measure: Adverse events
timeFrame: Between 6 and 12 months after treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferwson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Thomas N Tulenko, PhD
role: PRINCIPAL_INVESTIGATOR
References: