Can a nerve pain drug boost bladder pain relief?
NCT ID NCT07752134
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This trial is testing whether adding the nerve pain medication pregabalin to a structured educational and behavioral program can better ease the symptoms of bladder pain syndrome (also called interstitial cystitis) than the program alone. Adults with this condition will be randomly assigned to receive either the program by itself or the program plus pregabalin, with doses adjusted over 12 weeks. Researchers will compare how many people in each group report meaningful improvement in their overall well-being, and will also track pain, urinary symptoms, sleep, and quality of life. The goal is to see if the combination offers a more effective way to manage this chronic, painful condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pregabalin combined with an educational and behavioral management program
- What this could lead to
- If successful, this combination could offer a more effective non-surgical option for managing bladder pain syndrome, potentially improving pain, urinary symptoms, and quality of life.
- What could go wrong
- This is an early-phase trial, so results may not hold up in larger studies. Pregabalin can cause side effects like dizziness and drowsiness, and the added benefit over education alone is not yet proven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria:- Adults aged 18 years and older * Clinically diagnosed with bladder pain syndrome/interstitial cystitis (IC/BPS) in accordance with diagnostic criteria released by AUA and ESSIC, with confounding disorders excluded through clinical workup * Persistent urinary symptoms across most days in the latest 3 months prior to enrollment * Participants report bladder pain/discomfort and urinary urgency/frequency scores ≥ 3 on the 0-10 Likert scale over the past 4 weeks Exclusion Criteria:- Symptomatic urethral stricture * Active neurological diseases that impair bladder or intestinal function * Active autoimmune disorders or infectious diseases * History of cystitis secondary to tuberculosis, pelvic radiotherapy or pelvic chemotherapy * Previous history of non-cutaneous malignant tumors * Confirmed severe psychiatric disorders at present, including major depressive disorder, bipolar disorder, schizophrenia and other serious mental illnesses * Severe systemic diseases featuring obvious dysfunction of the heart, lung, liver or kidney * Confirmed hypersensitivity to pregabalin * Concomitant use of additional antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs) * Pregnancy status * Lactation period
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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