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

Brain Imaging-based Strategies for Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain

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).

Study Overview

• Status: Terminated
• Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Drug: D-Cycloserine; Drug: Placebo (for D-cycloserine)

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
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	The visual analog scale (VAS) is a measurement tool used to assess the level of pain experienced by a patient. The scale is a 100 mm horizontal line, with one end representing "no pain" and the other end representing "worst pain imaginable." The patient is asked to mark on the line the point that best represents their level of pain. The minimum score is 0 mm, indicating no pain, while the maximum score is 100 mm, indicating the worst pain imaginable. Higher scores on the VAS indicate a worse outcome, while lower scores indicate a better outcome. The VAS score can be determined by measuring the distance in millimeters from the left end of the line to the point marked by the patient. The range of scores can be used to interpret the level of pain experienced by the patient, with higher scores indicating greater pain severity.	18 weeks after baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
McGill Pain Questionnaire	Includes a numeric/descriptor scale, a visual analogue scale (VAS), and a body map to localize the pain.	18 weeks after baseline visit
Functional Magnetic Resonance Imaging (fMRI) connectivity	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.	12 weeks after baseline visit

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Vania Apkarian, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 5, 2015
• First Posted (Estimate): March 11, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Interstitial cystitis with Painful Bladder Syndrome; Urological Chronic Pelvic Pain Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Prostatic Diseases; Syndrome; Somatoform Disorders; Pelvic Pain; Prostatitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Anti-Bacterial Agents; Antitubercular Agents; Antibiotics, Antitubercular; Anti-Infective Agents, Urinary; Renal Agents; Cycloserine
• Other Study ID Numbers: STU00085782; R01DK100924-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following publication of primary analyses, de-identified scan and clinical data will be posted to NIH-sponsored Open Pain database.