Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain

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.

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.