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New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Enrollment target: 38 to 5v4 Show 6 more changesShow less
    • Primary completion date: Jan 2026 to Dec 2026
    • Study completion date: May 2026 to Dec 2026
    • Interventions: Pulsed radiofrequency ablation (Procedure), Sham ablation (Procedure) to Pulsed radiofrequency ablation (Procedure)
    • Study description shortened, about 12 words
    • Site contact updated
    • Study arms: 2 to 1
  2. Minor Study description shortened, about 43 words
    • Publications: 1 to 33
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2024 to Jan 1, 2024
    • Study description expanded, about 1,189 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06204874
Lead Sponsor Walter Reed National Military Medical Center
Conditions
(from sponsor)
Bladder Pain Syndrome
Related terms Cystitis, Interstitial
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov