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Can a nerve pain drug calm the bladder?

NCT ID NCT07803393

Disease control Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether adding the drug mirogabalin to a structured educational and behavioral program improves symptoms for adults with interstitial cystitis or bladder pain syndrome. Participants receive either the behavioral program alone or the program plus mirogabalin for 12 weeks. Researchers compare symptom response, pain, urinary frequency, quality of life, and safety between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mirogabalin, an oral drug for nerve-related pain, combined with a structured educational and behavioral program
What this could lead to
If it works, adding mirogabalin to a behavioral program could offer a new way to ease bladder pain and urgency for people with interstitial cystitis.
What could go wrong
This is an early-phase, open-label trial, so results may not hold up in larger blinded studies. Mirogabalin can cause side effects like dizziness and sleepiness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

interstitial cystitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder pain syndrome Educational behavioral intervention Urinary urgency

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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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