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Can a depression drug ease bladder pain? new study investigates

NCT ID NCT00124306

Symptom relief Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether amitriptyline, a drug already used for depression and some chronic pain conditions, can relieve symptoms of painful bladder syndrome (PBS) in people newly diagnosed with the condition. PBS causes frequent urination and increasing pain as the bladder fills, affecting millions, mostly women. The trial enrolled 271 participants and measured symptom improvement using a patient-reported global response assessment after 12 weeks.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

271 people

The number who actually took part.

Start date

Feb 2005

Finished

Dec 2008

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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

Accepted

You do not need to have the condition being studied to take part.

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: * Participant must report bladder pain/discomfort score of 3 or greater on a 0-10 Likert scale over the previous 4 weeks. * Participant must report a symptom score of abnormal urinary frequency of 3 or greater on a 0-10 Likert scale over the previous 4 weeks. * Symptoms of abnormal urinary frequency and bladder pain/discomfort must have been present for at least six weeks prior to screening visit. Exclusion Criteria: * Known allergy or intolerance to amitriptyline or any of its components. * Currently receives treatment with amitriptyline or other tricyclic antidepressant, selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), or monoamine oxidase (MAO) inhibitor antidepressants. * Previous treatment with amitriptyline or other tricyclics, hydroxyzine or other antihistamines for bladder symptoms; pentosanpolysulfate; DMSO or any other intravesical therapy, biofeedback or pelvic floor physical therapy for PBS symptoms

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Conditions

The condition(s) this trial relates to.

interstitial cystitis urinary bladder disorder

As listed by the trial registrant

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

Bladder diseases Interstitial cystitis

Contacts and locations

Locations

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Queen's University

    Kingston, Ontario, K7L 2Y7, Canada

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • University of Iowa Hospitals and Clinic

    Iowa City, Iowa, 52242, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.