New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome

NCT06204874 | Recruiting

• 1 other identifier: WRNMMC-2023-0433
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• VAS Pain Score

  The visual analog scale (VAS) is a validated, subjective measure for pain. Scores are recorded by making a mark at any number of defined intervals on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). Scale from 0-10, with higher scores indicating worse outcome.

  At the initial appointment and at 1-, 3-, and 6-month follow-ups.

Secondary Outcomes (7)

• O' Leary-Sant Voiding and Pain Indices

  At the initial appointment and at 1-, 3-, and 6-month follow-ups.

• Average number of daytime voids over the prior week

  At the initial appointment and at 1-, 3-, and 6-month follow-ups.

• Average number of daytime episodes of urinary incontinence over the prior week

  At the initial appointment and at 1-, 3-, and 6-month follow-ups.

• Patient Health Questionnaire - 9 (PHQ-9)

  At the initial appointment and at 1-, 3-, and 6-month follow-ups.

• Number of treatments currently taking for BPS

  At the initial appointment and at 1-, 3-, and 6-month follow-ups.

Study Arms (1)

Pulsed Radiofrequency Ablation Arm

EXPERIMENTAL

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.

Procedure: Pulsed radiofrequency ablation

Interventions

Pulsed radiofrequency ablation PROCEDURE

See left.

Pulsed Radiofrequency Ablation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Eli Medvescek, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eli Medvescek, MD

CONTACT

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

Sara Wilson, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Anesthesiology

Model Details: Single center case series.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 12, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)