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NCT06204874 · ClinicalTrials.gov registry record · NA
New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome
A NA study of Bladder Pain Syndrome, sponsored by Walter Reed National Military Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT06204874 is a NA study of Bladder Pain Syndrome that is actively recruiting participants, run by Walter Reed National Military Medical Center. The registered enrollment target is 38 participants, below the 167-participant average among 13 other Bladder Pain Syndrome trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06204874, a NA study of Bladder Pain Syndrome, is actively recruiting participants, sponsored by Walter Reed National Military Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study 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 over the use of placebo? 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. Some participants will receive treatment, whereas others will receive sham (placebo). Participants will not be informed of their treatment group until the conclusion of the study. 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 compare treatment and sham groups to see if pain scores, as well as other secondary outcomes listed above, are different between these groups
Conditions Studied
Interventions
- PROCEDURE Pulsed radiofrequency ablation
- PROCEDURE Sham ablation
Study Locations (1)
Maryland
- Walter Reed National Military Medical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2026-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06204874
The ClinicalTrials.gov registry entry for NCT06204874 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 167-participant average among 13 other Bladder Pain Syndrome trials with a reported enrollment target (77% lower). The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bladder Pain Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Pulsed radiofrequency ablation is the first listed.
NCT06204874 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06204874 about?
NCT06204874 is a clinical study titled "New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome". 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...
What is the current status of trial NCT06204874?
This trial is currently recruiting. It is a NA study. The enrollment target is 38 participants. The study started on 2024-01-01. Estimated completion is 2026-05.
What conditions does trial NCT06204874 study?
This clinical trial studies the following conditions: Bladder Pain Syndrome.
What interventions are being tested in trial NCT06204874?
The interventions under investigation include: Pulsed radiofrequency ablation (PROCEDURE), Sham ablation (PROCEDURE).
Who is sponsoring clinical trial NCT06204874?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06204874 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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