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

Active, not recruiting

• Conditions: Chronic Pelvic Pain Syndrome

• Registration Number: NCT06425575
• Lead Sponsor: Thomas Jefferson University

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
...

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 ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2023-10-31
• Study First Submitted: 2024-02-21
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

All patients 18 years of age or older who present with chronic pelvic pain -

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Pain and overall quality of life	Between 6 and 12 months after treatment	Pain in structures of the genitalia, rectum and pain during sexual activity

Secondary Outcome Measures

Name	Time	Method
Adverse events	Between 6 and 12 months after treatment	Zero pain relief
Bladder pain and urination frequency	Between 6 and 12 months after treatment	Symptoms relating to interstitial cystitis

Trial Locations

Locations (1)

Thomas Jefferwson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States