Resolution of Pudendal Neuralgia in Chronic Pelvic Pain Using a Novel Biologic Therapy

May 17, 2024 updated by: Thomas N. Tulenko, Thomas Jefferson University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferwson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All women presenting with chronic pelvic pain who are over 18 and without terminal disease

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Pain and overall quality of life
Time Frame: Between 6 and 12 months after treatment
Pain in structures of the genitalia, rectum and pain during sexual activity
Between 6 and 12 months after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bladder pain and urination frequency
Time Frame: Between 6 and 12 months after treatment
Symptoms relating to interstitial cystitis
Between 6 and 12 months after treatment
Adverse events
Time Frame: Between 6 and 12 months after treatment
Zero pain relief
Between 6 and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Cooper Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas N Tulenko, PhD, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18D.719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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