Status:
RECRUITING
New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Bladder Pain Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Many women suffer from bladder pain syndrome (BPS). There are many treatments, but there is no one universally effective option. The goal of this clinical trial is to explore the use of electrical ene...
Detailed Description
Interstitial cystitis / bladder pain syndrome (IC/BPS) is a complex chronic pain syndrome characterized by bladder pain, pressure, and discomfort with urinary urgency and frequency, without signs of i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06204874
Start Date
January 1 2024
End Date
May 1 2026
Last Update
May 14 2024
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814