Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain

NCT ID: NCT02385266

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-06-30

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).

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.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

D-Cycloserine and Acetominophen

D-cycloserine 200mg/bid and Acetaminophen prn

Group Type: EXPERIMENTAL

D-Cycloserine

Intervention Type: DRUG

Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.

Placebo and Acetominophen

Placebo capsules (lactose)/bid and Acetaminophen prn

Group Type: PLACEBO_COMPARATOR

Placebo (for D-cycloserine)

Intervention Type: DRUG

Lactose filled capsules to mimic DCS 200mg capsules

Interventions

D-Cycloserine

Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.

Intervention Type: DRUG

Placebo (for D-cycloserine)

Lactose filled capsules to mimic DCS 200mg capsules

Intervention Type: DRUG

Other Intervention Names

Seromycin; Tylenol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Apkar Apkarian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vania Apkarian, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R01DK100924-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00085782

Identifier Type: -

Identifier Source: org_study_id