TerminatedPhase 4

Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain

Stopped: The study was closed due to recruitment limitations

United States24 participantsStarted 2013-09

Plain-language summary

The purpose of this study is to evaluate the efficacy of D-Cycloserine versus placebo treatment in reducing pain from urological chronic pelvic pain syndrome (UCPPS).

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males greater than 18 years of age, with no racial/ethnic restrictions; * Meets diagnostic criteria for Interstitial Cystitis with Painful Bladder Syndrome (IC/PBS) and/or Chronic Prostatitis with Chronic Pelvic Pain Syndrome (CP/CPPS); * Reports symptoms of discomfort or pain in the pelvic or abdominal region for at least a 3 mo period within the last 6 mo; * Must have a Visual Analog Scale (VAS) pain score \>40 mm (of 100 mm maximum) at the baseline visit (UCPPS pain moderate to severe); * Must be in generally stable health; * Must be willing to abstain from drinking alcohol during the course of the study; * Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires; * Must sign an informed consent document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate. Exclusion Criteria: * Urological pain associated with any systemic signs or symptoms, e.g., fever, chills; * Evidence of a facultative Gram negative or enterococcus with a value of ≥ 100,000 CFU/ml in mid-stream urine (VB2); * Has a second chronic pain condition (e.g., chronic low back pain, temporomandibular joint syndrome, etc.) that would prevent a clear interpretation of the study results; * History of tuberculous cystitis, bladder cancer, carcinoma in situ, prostate cancer, or urethral cance…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analog Scale (VAS)

Timeframe: 18 weeks after baseline visit

Trial details

NCT IDNCT02385266

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

Results submitted2023-02-17

View on ClinicalTrials.gov More Chronic Prostatitis With Chronic Pelvic Pain Syndrome trials