New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Walter Reed National Military Medical Center
Study ID
NCT06204874
Status
Recruiting
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Conditions

  • Bladder Pain Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pulsed radiofrequency ablation — PROCEDURE
    See left.

Study Details

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 energy directed towards a group of nerves, called the superior hypogastric plexus, for treatment of BPS in women over the age of 18 with a diagnosis of BPS. The main question it aims to answer is: does use of electrical micro-current directed at the superior hypogastric plexus improve pain associated with BPS? There is data from many different studies that suggest that this kind of therapy might provide relief of BPS symptoms. Participants will be asked to participate for a total of six months from the date of their first nerve treatment. At the first appointment, they will be evaluated in the Walter Reed Chronic Pain clinic and asked several questions about the severity and personal management of their symptoms. The procedure will then be performed by inserting two needles into the back (one on either side of the spine) and directing extremely short bursts of electrical micro-current towards the target nerve. The medical term for this is "pulsed radiofrequency ablation." This procedure causes disruption on a microscopic level of nerve fibers that send pain sensations to the bladder and other organs in the pelvis. Following this initial appointment, participants will be asked about their symptoms at 1-, 3-, and 6-month follow-up appointments. Participants will be asked about pain, mood symptoms, sexual function, and measures of bladder irritation. The procedure will only be performed once. At the study conclusion, researchers will analyze pain scores, as well as other secondary outcomes listed above. Benefits of this study may include possible relief of BPS symptoms. This may help to advance research about treatments for BPS. This is a novel approach to the treatment of BPS and as such may provide benefits greater than those found in treatment outside of the study.

Key Dates

Start date
Jan 1, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pulsed Radiofrequency Ablation Arm
    5 total subjects in this arm. Subjects will be laid in the prone position. Local anesthesia will be administered. The appropriate spinal interspace will be identified under fluoroscopic guidance and hollow-tip needles will be inserted through the back into the retroperitoneal space adjacent to the superior hypogastric plexus. A microelectrode will be inserted through the hollow needle. A test pulse will be delivered. When proper positioning has been confirmed, 4mL of 1% lidocaine without epinephrine will be administered to reduce discomfort associated with radiofrequency ablation. Pulsed radiofrequency ablation will be performed at a pulse frequency of 2Hz, pulse width of 20ms, temperature of 42 degrees Celsius, total duration 120 seconds. The microelectrode and hollow-tip needle will then be withdrawn.

Primary Outcome Measure

VAS Pain Score [ Time Frame: At the initial appointment and at 1-, 3-, and 6-month follow-ups. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20814
Eli Medvescek, MD
[email protected]
5207806888

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Walter Reed National Military Medical Center· Bethesda, MD

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