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

NCT06425575 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-05-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

Amniotic suspension allograft

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

Sponsors & Collaborators

  • The Cooper Health System

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Thomas N Tulenko, PhD · Thomas Jefferson University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2023-10-31
Completion
2024-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06425575 on ClinicalTrials.gov