## Protocol Section
### Identification Module
**NCT ID:** NCT06425575

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 18D.719
#### Organization
**Class:** OTHER
**Full Name:** Thomas Jefferson University
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-10-31

**Type:** ACTUAL

#### Start Date
**Date:** 2019-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-21
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** The Cooper Health System

#### Lead Sponsor

**Class:** OTHER

**Name:** Thomas Jefferson University

#### Responsible Party

**Investigator Affiliation:** Thomas Jefferson University

**Investigator Full Name:** Thomas N. Tulenko

**Investigator Title:** Adjunct Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Chronic Pelvic Pain Syndrome

**Keywords:**

- pudendal neuralgia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** the amniotic suspension allograft consists of fresh amniotic fluid into which micronized amniotic membrane has been added as a suspension.

**Name:** Amniotic suspension allograft

**Other Names:**

- Rheo, Flowgraft

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Pain in structures of the genitalia, rectum and pain during sexual activity

**Measure:** Overall Pain and overall quality of life

**Time Frame:** Between 6 and 12 months after treatment

#### Secondary Outcomes

**Description:** Symptoms relating to interstitial cystitis

**Measure:** Bladder pain and urination frequency

**Time Frame:** Between 6 and 12 months after treatment

**Description:** Zero pain relief

**Measure:** Adverse events

**Time Frame:** Between 6 and 12 months after treatment

### Eligibility Module

**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 -

**Gender Based:** True

**Gender Description:** All patients with clinically demonstrable chronic pelvic pain who are 18 years or older..

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All women presenting with chronic pelvic pain who are over 18 and without terminal disease

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Philadelphia

**Country:** United States

**Facility:** Thomas Jefferwson University Hospital

**State:** Pennsylvania

**Zip:** 19107

#### Overall Officials

**Official 1:**

**Affiliation:** Thomas Jefferson University

**Name:** Thomas N Tulenko, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009408

- Term: Nerve Compression Syndromes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12381

- Name: Neuralgia

- Relevance: HIGH

- As Found: Neuralgia

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M19918

- Name: Pelvic Pain

- Relevance: HIGH

- As Found: Pelvic Pain

- ID: M29660

- Name: Pudendal Neuralgia

- Relevance: HIGH

- As Found: Pudendal Neuralgia

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12352

- Name: Nerve Compression Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M5853

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18092

- Name: Hereditary Sensory and Motor Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T4805

- Name: Pudendal Neuralgia

- Relevance: HIGH

- As Found: Pudendal Neuralgia

- ID: T1081

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: T2761

- Name: Hereditary Motor and Sensory Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: T2766

- Name: Hereditary Neuropathy With Liability to Pressure Palsies

- Relevance: LOW

- As Found: Unknown

- ID: T5067

- Name: Roussy Levy Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009437

- Term: Neuralgia

- ID: D000060545

- Term: Pudendal Neuralgia

- ID: D000017699

- Term: Pelvic Pain

### Misc Info Module

- Version Holder: 2024-05-31
