Exploring nerve stimulation therapy for bladder pain syndrome in women
Evaluation of Pulsed Radiofrequency Ablation of the Superior Hypogastric Plexus for Treatment of Bladder Pain Syndrome: A Case Series
This study is testing if a new nerve stimulation therapy can help women with bladder pain syndrome feel less pain compared to a placebo treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06204874 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older diagnosed with bladder pain syndrome.
Not a fit: Patients with active pelvic malignancies, current neurostimulation devices, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide significant pain relief for women suffering from bladder pain syndrome.
How similar studies have performed: Previous studies have suggested that nerve stimulation therapies may alleviate symptoms of bladder pain syndrome, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.