Assessing pain types in treating bladder pain syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate how different phenotypes of interstitial cystitis/bladder pain syndrome (IC/BPS) affect responses to two therapies: pelvic floor physical therapy and cognitive-behavioral therapy. The study will involve a randomized mechanistic trial to identify which patients benefit from each treatment based on their pain distribution. By understanding the neurobiological mechanisms that may influence treatment outcomes, the research seeks to improve personalized care for individuals suffering from this debilitating condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years of age or older;
* Diagnosis of IC/BPS as indicated by structured assessments;
* Capable of giving written informed consent;
* Able to enroll for the duration of the study period;

Exclusion Criteria:

* Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke;
* Current or history of diagnosis of primary psychotic or major thought disorder within the past five years;
* Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years);
* Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, active suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months;
* Non-English speaking;
* Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking;
* Difficulties or limitations communicating over the telephone or via teleconferencing systems;
* Any planned life events that would interfere with participating in the key elements of the study;
* Any major active medical issues that could preclude participation;
* Currently pregnant;
* Currently being treated for cancer;
* Cancer-related pain;
* Recently or actively participating in treatment similar to those being investigated (e.g. individual psychotherapy or pelvic floor pt).

Where it's running

• Vanderbilt Urology Cool Springs
  Franklin, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Lindsey McKernan, PhD, MPH — Vanderbilt University Medical Center
• Study coordinator: Lindsey McKernan, PhD, MPH
• Email: research.ocim@vumc.org
• Phone: 615-875-9990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PEMF therapy for women with bladder pain syndrome

  This study is testing if a new non-invasive treatment using pulsed electromagnetic fields can help women with bladder pain syndrome feel less pain and improve their urinary symptoms.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT05149573

• A program to ease pelvic pain through cognitive behavioral therapy

  This study is testing a short program of cognitive behavioral therapy to see if it can help people with chronic pelvic pain feel better compared to regular patient education.

  Recruiting State University of New York at Buffalo · Los Angeles, California and 2 other locations · NCT05127616

• Using aloe vera capsules to manage symptoms of interstitial cystitis

  This study is testing if taking aloe vera capsules can help people with interstitial cystitis feel less bladder pain and urinary frequency.

  Recruiting Early Phase 1 Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT04734106

• Aerobic Exercise and Massage for Painful Bladder Syndrome in Women

  This study tests whether adding aerobic exercise and connective tissue massage to patient education helps reduce bladder pain and improve symptoms for women with bladder pain syndrome.

  Recruiting Hacettepe University · Ankara, Ankara · NCT07839689

• Evaluating a catheter-free method for bladder medication delivery

  This study is testing a new way to deliver bladder medication without a catheter to see if it’s more comfortable and safer for people with conditions like interstitial cystitis and recurrent urinary tract infections.

  Recruiting at 2 sites Jahn Ferenc South Pest Teaching Hospital · Budapest and 1 other locations · NCT06719232

• Treatment of bladder pain using VNX001

  This study is testing a new treatment called VNX001 to see if it can help people with moderate to severe bladder pain feel better.

  Recruiting at 2 sites Phase 2 Vaneltix Pharma, Inc. · Tucson, Arizona and 4 other locations · NCT06394830

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.