New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome
NCT06204874 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2026-04-30
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
Interventions
- PROCEDURE
-
Pulsed radiofrequency ablation
See left.
Sponsors & Collaborators
-
Walter Reed National Military Medical Center
lead FED
Principal Investigators
-
Eli Medvescek, MD · Walter Reed National Military Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
More Related Trials
-
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
NCT07288411 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Patient Reported Outcomes Following Interventional Procedures in Pelvic Pain
NCT05531500 ·Status: UNKNOWN ·Phase: NA
-
Blinding and Adverse Effects of Ultrasonic Vagus Nerve Stimulation (U-VNS) in Tinnitus
NCT07291648 ·Status: COMPLETED ·Phase: NA
-
Respiratory-Gated Vagal Nerve Stimulation for Chronic Pain
NCT04053127 ·Status: COMPLETED ·Phase: NA
-
Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain
NCT02022722 ·Status: UNKNOWN ·Phase: PHASE4
-
Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
NCT03547518 ·Status: COMPLETED ·Phase: NA
-
Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder
NCT06349694 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effects of Transcutaneous Vagus Nerve Stimulation in Chronic Pain Patients and Healthy Controls
NCT05007743 ·Status: UNKNOWN ·Phase: NA
-
Transcutaneous Vagus Nerve Stimulation on Fibromyalgia- Double-blind, Sham-controlled Randomized Clinical Trial
NCT06912334 ·Status: RECRUITING ·Phase: NA
-
Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
NCT04936464 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
NCT06983470 ·Status: RECRUITING ·Phase: NA
-
Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain
NCT06847360 ·Status: RECRUITING ·Phase: NA
-
Noninvasive Brain Stimulation for Pain Relief
NCT04283643 ·Status: UNKNOWN ·Phase: NA
-
Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
NCT01818297 ·Status: TERMINATED ·Phase: NA
-
Comparison of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women
NCT02723279 ·Status: COMPLETED ·Phase: NA
-
Posterior Tibial Nerve Stimulation vs. Sham
NCT00534521 ·Status: COMPLETED ·Phase: PHASE3
-
Vagus Nerve Stimulation for Treating Adults With Severe Fibromyalgia
NCT00294281 ·Status: COMPLETED ·Phase: PHASE1
-
Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation
NCT07081412 ·Status: RECRUITING ·Phase: NA
-
Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study
NCT05350150 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
NCT06461312 ·Status: RECRUITING ·Phase: NA
-
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study
NCT03481725 ·Status: COMPLETED ·Phase: NA
-
Effects of taVNS on Postoperative Pain in Complex Spinal Surgery
NCT07330973 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Brain Effect of Vagal Nerve Stimulation at Rest and Pain
NCT04282226 ·Status: WITHDRAWN ·Phase: NA
-
Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome
NCT04428619 ·Status: COMPLETED ·Phase: NA
-
Utilization of the BIOWAVE Device to Treat Overactive Bladder
NCT01848366 ·Status: COMPLETED ·Phase: NA