Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06204874

Evaluation of Pulsed Radiofrequency Ablation of the Superior Hypogastric Plexus for Treatment of Bladder Pain Syndrome A Case Series

Led by Walter Reed National Military Medical Center · Updated on 2026-04-30

5

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Bladder Pain Syndrome (BPS) is a complex chronic pain condition mainly affecting women, characterized by bladder pain, pressure, and discomfort alongside urinary urgency and frequency. This study aims to explore whether using electrical micro-current directed at the superior hypogastric plexus, a nerve group involved in pelvic pain, can reduce pain in women aged 18 and older diagnosed with BPS. Current treatments vary and are not universally effective, so this research investigates a novel approach called pulsed radiofrequency ablation (pRFA) for pain relief. Participants will undergo a one-time procedure where two needles are inserted near the spine to deliver brief bursts of electrical micro-current to the target nerve, targeting pain pathways. The procedure includes local anesthesia and fluoroscopic guidance. After treatment, participants will have follow-up visits at 1, 3, and 6 months to assess pain, mood, sexual function, and bladder irritation symptoms. The study focuses on evaluating changes in pain scores and other relevant symptoms over six months. Participants will be evaluated at the start and during follow-up visits in a chronic pain clinic setting. Assessments include pain severity using the Visual Analog Scale (VAS), bladder symptom indices, urinary frequency, mood questionnaires, and patient-reported impressions of symptom severity and improvement. Researchers will closely monitor these measures to understand the effects of the treatment. The total participation time is six months from the initial procedure, with detailed symptom tracking throughout the study period.

CONDITIONS

Brief Title

New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Age greater than or equal to 18
  • Diagnosis of Bladder Pain Syndrome with a score of 6 or higher on O'Leary-Sant Voiding and Pain Indices
  • DEERS-eligible health care beneficiaries
Not Eligible

You will not qualify if you...

  • Current enabled implantable neurostimulation devices (e.g., TENS unit, Interstim)
  • Active pelvic or gynecologic cancer
  • Coagulation disorders
  • Infection at the injection site
  • Sepsis
  • Decompensated cardiac or hemodynamic conditions
  • Neurogenic bladder or spinal cord injury
  • Current pregnancy
  • Spine abnormalities preventing the procedure
  • Onabotulinumtoxin A bladder injection within the last 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session

Participants receive pulsed radiofrequency ablation targeting the superior hypogastric plexus to treat bladder pain syndrome.

1 treatment visit (in-person)

Follow-up

Duration - 6 months

Participants are monitored for pain and symptom relief with assessments of pain, urinary symptoms, mood, and overall satisfaction.

3 follow-up visits at 1, 3, and 6 months (in-person)

Trial Site Locations

Total: 1 location

1

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20814

Actively Recruiting

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Research Team

E

Eli Medvescek, MD

S

Sara Wilson, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Sacral Neuromodulation for Refractory Bladder Pain Syndrome/Interstitial Cystitis: a Global Systematic Review and Meta-analysis.

Junpeng Wang, Yang Chen, Jiawei Chen...

https://pubmed.ncbi.nlm.nih.gov/28887515

A multidisciplinary approach to the evaluation and management of interstitial cystitis/bladder pain syndrome: an ideal model of care.

Priyanka Gupta, Natalie Gaines, Larry T Sirls...

https://pubmed.ncbi.nlm.nih.gov/26816861

Can the adrenergic system be implicated in the pathophysiology of bladder pain syndrome/interstitial cystitis? A clinical and experimental study.

Ana Charrua, Rui Pinto, Anna Taylor...

https://pubmed.ncbi.nlm.nih.gov/24375689