Bladder Pain Syndrome Clinical Trial
Official title:
Evaluation of Pulsed Radiofrequency Ablation of the Superior Hypogastric Plexus for Treatment of Bladder Pain Syndrome: A Randomized, Placebo-Controlled Pilot Study
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. 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.
Status | Recruiting |
Enrollment | 38 |
Est. completion date | May 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Walter Reed National Military Medical Center |
United States,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | O' Leary-Sant Voiding and Pain Indices | Standardized, validated survey querying numerical ratings of urinary urgency, urinary frequency, nocturia, and bladder pain/burning. Scale from 0-37, with higher score indicating worse outcome. | At the initial appointment and at 1-, 3-, and 6-month follow-ups. | |
Secondary | Average number of daytime voids over the prior week | Average number of daytime voids over the prior week | At the initial appointment and at 1-, 3-, and 6-month follow-ups. | |
Secondary | Average number of daytime episodes of urinary incontinence over the prior week | 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. | |
Secondary | Patient Health Questionnaire - 9 (PHQ-9) | The PHQ-9 is a validated, 9-question tool to assess for the degree of depression present in an individual. Scale from 0-27, with higher scores indicating worse outcome. | At the initial appointment and at 1-, 3-, and 6-month follow-ups. | |
Secondary | Number of treatments currently taking for BPS | Number of treatments currently taking for BPS | At the initial appointment and at 1-, 3-, and 6-month follow-ups. | |
Secondary | Patient Global Impression of Severity (PGI-S) | Global index that may be used to rate the severity of a specific condition (PGI-S). Validated on women with stress urinary incontinence. Nonnumeric, condition is rated on a 4-point Likert scale from "normal" to "severe" | At the initial appointment and at 1-, 3-, and 6-month follow-ups. | |
Secondary | Patient Global Impression of Improvement (PGI-I) | Global index that may be used to rate the response of a condition to a therapy. Validated on women with stress urinary incontinence. Nonnumeric, condition is rated on a 7-point Likert scale from "very much worse" to "very much better." | At the initial appointment and at 1-, 3-, and 6-month follow-ups. |
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