Clinical Trials, Research and Science

Modern Science required for Pudendal Neuralgia

The main aim of Clinical Trials is to prove, by scientific means, the effects and limitations of the experimental treatment of drugs, medical devices, or treatments/surgeries designed to prevent, or treat condition, and ultimately cure a condition or disease. 1

There are two main types of clinical research: observational studies and clinical trials.

1. Clinical Trials: are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people.

Often, a clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.

2. Observational Studies: monitor people in normal settings. Observational studies do not test a medical intervention, such as a drug or device, but may help identify new treatments or prevention strategies to test in clinical trials.

Trials gathers additional information from several hundred to a few thousand people about safety and effectiveness, studying different populations . . . If the FDA agrees that the trial results support the intervention’s use for a particular health condition, it will approve the experimental drug or device. 2

What is a Blinded Study?

Blinding or masking refers to the withholding of information regarding treatment allocation from one or more participants and/or researchers in a clinical research study. It is an essential methodological feature of clinical studies that help maximize the validity [remove bias] of the research results. 3

Pudendal Neuralgia Alliance requests that doctors, hospitals, and/or universities conduct clinical trials of all treatments and medications already being used on people with pudendal neuralgia to conclude the efficacy and safety which are by current medical standards unknown.

Until the FDA approves a medical device, procedure, or medication, patients must pay cash out of pocket. Costs range from a few hundred to tens of thousands of dollars in addition to travel and lodging which puts them out of reach of 99% of those suffering the severe daily pain of pudendal neuralgia (PN).

In all, this means most treatments for PN:

Have not been properly studied for efficacy and safety
Have not been approved by the FDA
Are not affordable and therefore are not obtainable for 99% of Americans with PN which leaves them with almost no true medical care, and no hope of recovery from this debilitating condition.

No More Time To Waste

We have already posted that pudendal neuralgia was named and discovered by doctor in France in 1987.

We also have reported that, in 2008, a group of eight French pudendal neuralgia specialists in Nantes France (names listed under main menu Home), validated and published a set of simple diagnostic criteria which is considered the international gold standard known as The Nantes Criteria. That was 16 years ago.

Medical researchers for other horrendous and often deadly diseases are relentlessly researching treatments and cures

such as epilepsy, Parkinson's, ALS or amyotrophic lateral sclerosis aka Lou Gehrig's disease, Trigeminal neuralgia, spinal cord paralysis, Multiple Sclerosis, Alzheimer's Disease, Cystic Fibrosis, and an endless list of others.

Medical professionals or administrative executives need to apply this same focused and persistent research for treatments and cures for pudendal neuralgia today. There has been little to no progress in over a decade.

Doctors ought to apply the same boldness and, dedication to finding medical proven treatments and a cure for to pudendal neuralgia. They need to forthwith conduct statistically meaningful medical Double-Blind studies and/or publish short-term and long-term observational effects and safety for the treatments below which doctors have already been using for over a decade:

NEED CLINICAL TRIALS and SCIENTFIC PUBLICATIONS

Peripheral Nerve Stimulation medical devices (all companies' devices currently being implanted)
Sacral Nerve Stimulation medical devices (all companies' devices currently being implanted)
Pulsed Radiofrequency Treatment (PRF)
Ganglion Impar Block
Hypogastric Plexus Block
Ilioinguinal and Iliohypogastric Block
Oral Medications
Pudendal Nerve Blocks used at a Treatment (currently only FDA approved as Diagnostic procedure)
REPEAT French "first prospective, randomised, double‐blind study concluding corticosteroids added to pudendal nerve block for pudendal neuralgia . . . shows that adding corticosteroids provides no advantage 3 months after nerve bloc. Corticosteroids provide no additional therapeutic benefits compared with local anaesthetic and should therefore no longer be used." Antithetical to this science, 99% of U.S. doctors still inject a steroid with a diagnostic pudendal nerve block and charge patients the addition cost in spite of this study published in the international medical journal Wiley well over a decade ago. 4

Highly suspect treatments

Cryoablaion / Cryoneurolysis (ablation/destruction through freezing using probe, creates incontinence)
Stem Cell Therapy / Rheo injections
Hydrodissection injections (water)
Platelet-Rich Plasma (PRP) Injections
Alpha-2-Macroglobulin (A2M) injections
Prolotherapy injections (dextrose/sugar water irritant)
Hyaluronic acid injections

The types of evidence are listed from strongest to weakest:

1. Systematic Review

Systematic reviews draw on multiple randomized controlled double-blind trials to draw their conclusions, and also

take into consideration the quality of the studies included. Reviews can help mitigate bias in individual studies and

give us a more complete picture, making them the best form of evidence.

2. Randomized Controlled Trials - Double-Blind (experimental)

Subjects are randomly assigned either to a:
1. Test group, which receives the treatment, or
2. Control group, which receives a placebo. A placebo is any treatment with no active properties, like a sugar pill.

- Double-Blind trials, neither the participants nor experimenters know which group anyone is in --

Blinding trials helps remove bias.

- Blind trials, only the experimenters know which group participants are in.

3. Cohort Studies (observational)

A cohort study is similar to a case-control study. It involves selection of a group of people sharing a certain

characteristic or treatment (e.g. exposure to a chemical), and compares them over time to a group of people who

do not have this characteristic or treatment, noting any difference in outcome.

4. Case-Control Studies (observational)

Case-control studies are retrospective, involving two groups of subjects, one with a particular condition or

symptom, and one without. They then track back to determine an attribute or exposure that could have caused this. Again, these studies show correlation, but it is hard to prove causation.

5. Case Reports & Case Series (observational)

A case report is a written record on a particular subject. Though low on the hierarchy of evidence, they can aid

detection of new diseases, or side effects of treatments. A case series is similar, but tracks multiple subjects.

Both types of study cannot prove causation, only correlation.

6. Anecdotal & Expert Opinions

Anecdotal evidence is a person’s own personal experience or opinion, not representative of typical experiences.

An expert’s standalone opinion, or that given in a written news article. Both are weak forms of evidence

without scientific studies to back them up. 5, 6

1 https://pubmed.ncbi.nlm.nih.gov/31536248/ Double-Blind Study National Library of Medicine (NLM), National Center for Biotechnology Information (NCBI)

2 https://www.nia.nih.gov/health/clinical-trials-and-studies/what-are-clinical-trials-and-studies

3 https://www.simplypsychology.org/double-blind-experimental-study-and-procedure-explained.html#:~:text=Binding%2C%20or%20masking%2C%20refers%20to,avoid%20bias%20in%20the%20research

4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215631/ Adding corticosteroids to the pudendal nerve block for pudendal neuralgia: a randomised, double‐blind, controlled trial. Registered in the European Clinical Trial Registry: EudraCT no. 2008-003914-87 (registered 21 October 2008) and in the International Clinical Trial Registry Platform under no. NCT 00851513 (registered 25 February 2009). Published Jul 27 by Wiley Online. Funded exclusively by a budget from the French Ministry of Health (Paris), after a national Hospital Clinical Research Protocol call for tenders

5 https://www.sciencemediacentre.co.nz/coveringscience/types-of-scientific-evidence/#:~:text=A%20case%20report%20is%20a,cannot%20prove%20causation%2C%20only%20correlation.

6 https://www.epilepsy.com/stories/learning-research-strength-evidence Epilepsy Foundation - Learning from Research: Strength of the Evidence

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Pudendal Neuralgia Alliance

contact@pudendalneuralgiaalliance.org

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