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Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain (UCPPS)

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ClinicalTrials.gov Identifier: NCT02385266
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : September 30, 2016
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Apkar Apkarian, Northwestern University

Brief 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).

Condition or disease Intervention/treatment Phase
Chronic Prostatitis With Chronic Pelvic Pain Syndrome Drug: D-Cycloserine Drug: Placebo (for D-cycloserine) Phase 4

Detailed Description:

This is a double blinded, randomized control trial (RCT) over a 21 week period that aims to evaluate the treatment efficacy of placebo and D-cycloserine(DCS) in men suffering from UCPPS. The brain functional and anatomical properties associated with treatment response will also be examined.

This study will emphasize on comparing, both clinically and by brain imaging, the analgesic response to placebo in both placebo responders and non-responders in addition to a novel treatment (DCS) that targets the brain's pain mechanism for UCPPS.

Subjects will be randomized to 2 arms, in a 1:1 ratio, to a DCS medication group (n=20) and a placebo medication group (n=20). Questionnaire outcomes and brain scans will occur prior to initiating treatment and at the end of the treatment period. The actual visits required are minimized, 9 visits spread out over 21 weeks, as pain, quality of life and pill ingestion timings are collected using a secure study website accessible electronically.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Imaging-based Strategies for Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain
Study Start Date : September 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain
Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: D-Cycloserine and Acetominophen
D-cycloserine 200mg/bid and Acetaminophen prn
Drug: D-Cycloserine
Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.
Other Name: Seromycin

Placebo Comparator: Placebo and Acetominophen
Placebo capsules (lactose)/bid and Acetaminophen prn
Drug: Placebo (for D-cycloserine)
Lactose filled capsules to mimic DCS 200mg capsules
Other Name: Tylenol




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 18 weeks after baseline visit ]
    A horizontal line, 100 mm in length, anchored by no pain at left end of line and worst possible pain at the right end of line. VAS score is later determined by measuring in millimeters from the left hand to the point where the patient marks.


Secondary Outcome Measures :
  1. McGill Pain Questionnaire [ Time Frame: 18 weeks after baseline visit ]
    Includes a numeric/descriptor scale, a visual analogue scale (VAS), and a body map to localize the pain.

  2. Functional Magnetic Resonance Imaging (fMRI) connectivity [ Time Frame: 12 weeks after baseline visit ]
    A type of brain scan that uses magnetic fields and radio waves to make an image of changes in blood flow in your brain while you do certain tasks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 cancer;
  • History of significant pelvic comorbidities, including inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy, or has been treated with intravesical Bacillus Calmette-Guerin (BCG) or unilateral orchialgia without other pelvic symptoms, has an active urethral stricture, ureteral calculi, urethral diverticulum, or has a neurological disease or disorder affecting the bladder;
  • Significant other medical conditions/diseases, such as significant renal disease or a history of renal insufficiency, unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy;
  • Neurologic disorder, including history of seizures;
  • Major psychiatric disorder during the past 6 months;
  • Moderate or severe depression, as determined by the Hospital Anxiety and Depression Scale, or any active suicidal ideation;
  • History of, or current, substance abuse/dependence including alcohol;
  • Known sensitivity to D-cycloserine;
  • Currently taking any of the following medications: ethionamide, dilantin, isoniazid (INH), pyridoxine (vitamin B6)
  • Use of therapeutic doses of antidepressant medications (i.e., tricyclic depressants, Selective Serotonin Reuptake Inhibitor (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitor (SNRIs); low doses used for sleep may be allowed), as these medications can alter pain transmission;
  • Current use of low dose aspirin;
  • Indication that the subject is unlikely to be compliant due to unmanaged medical or psychological condition(s), including neurological, psychological, or speech/language problems that will interfere or prevent with his understanding of consent, his ability to comply with the protocol or ability to complete the study;
  • Any change in medication for urological pain in the last 30 days;
  • High dose opioid prophylaxis, as defined as > 50mg morphine equivalent/day;
  • Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
  • In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
  • Evidence of poor treatment compliance, in the judgment of the investigator;
  • Intra-axial implants (e.g. spinal cord stimulators or pumps); and
  • All exclusion criteria for Magnetic Resonance (MR) safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385266


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Vania Apkarian, PhD Northwestern University

Responsible Party: Apkar Apkarian, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02385266     History of Changes
Other Study ID Numbers: STU00085782
R01DK100924-01 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Following publication of primary analyses, de-identified scan and clinical data will be posted to NIH-sponsored Open Pain database.

Keywords provided by Apkar Apkarian, Northwestern University:
Interstitial cystitis with Painful Bladder Syndrome
Urological Chronic Pelvic Pain Syndrome

Additional relevant MeSH terms:
Syndrome
Pelvic Pain
Pain
Somatoform Disorders
Prostatitis
Disease
Pathologic Processes
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action