Recruiting

Nerve Stimulation Therapy

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT06204874

Conditions

Bladder Pain Syndrome

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pulsed radiofrequency ablation

Study Details

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 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.

Conditions

Bladder Pain Syndrome

Study ID

NCT06204874

Start date

Jan 1, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Pulsed radiofrequency ablation

See left.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Eli Medvescek, MD

520-780-6888eli.d.medvescek.mil@health.mil

Sara Wilson, MD

210-627-5302sara.m.wilson8.mil@health.mil

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Eli Medvescek, MD

5207806888eli.d.medvescek.mil@health.mil

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2026-04-30.