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

NCT06425575 | Active Not Recruiting FDA Drug

• 1 other identifier: 18D.719
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pelvic Pain Syndrome

Keywords

pudendal neuralgia

Outcome Measures

Primary Outcomes (1)

• Overall Pain and overall quality of life

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

  Between 6 and 12 months after treatment

Secondary Outcomes (2)

• Bladder pain and urination frequency

  Between 6 and 12 months after treatment

• Adverse events

  Between 6 and 12 months after treatment

Interventions

Amniotic suspension allograft BIOLOGICAL

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

Also known as: Rheo, Flowgraft

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All patients with clinically demonstrable chronic pelvic pain who are 18 years or older..
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• Under 18 years of age
• Malignancy defined as terminal -

Sponsors & Collaborators

• Thomas Jefferson University: lead
• The Cooper Health System: collaborator

Study Sites (1)

Thomas Jefferwson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pudendal Neuralgia

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas N Tulenko, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: May 22, 2024
• Study Start: April 1, 2019
• Primary Completion: October 31, 2023
• Study Completion: July 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)