Exploring nerve stimulation therapy for bladder pain syndrome in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of electrical energy directed at the superior hypogastric plexus to alleviate symptoms of bladder pain syndrome (BPS) in women over 18. Participants will undergo a procedure involving pulsed radiofrequency ablation or a sham treatment, with evaluations conducted at the Walter Reed Chronic Pain clinic. The study aims to determine if this nerve stimulation approach can significantly reduce pain compared to a placebo over a six-month period. The trial is designed to address the lack of universally effective treatments for BPS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female sex
* Age greater than or equal to 18
* Diagnosis of Bladder Pain Syndrome as evidenced by score greater than or equal to six on O'Leary-Sant Voiding and Pain Indices
* DEERS-eligible health care beneficiaries

Exclusion Criteria:

* Patients with current enabled implantable neurostimulation (i.e. transcutaneous electrical nerve stimulation unit, Interstim)
* Current active pelvic or gynecologic malignancy
* Coagulation disorder
* Local infection at injection site
* Sepsis
* Decompensated cardiac or hemodynamic disorders
* Neurogenic bladder and patients with spinal cord injury
* Current pregnancy
* Structural abnormalities of the spine that prevent performance of the procedure
* Intravesical onabotulinumtoxin A injection within the last 3 months

Where it's running

• Walter Reed National Military Medical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Eli Medvescek, MD — Walter Reed National Military Medical Center
• Study coordinator: Eli Medvescek, MD
• Email: eli.d.medvescek.mil@health.mil
• Phone: 520-780-6888

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment of bladder pain using VNX001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.