Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain

NCT02385266 | Terminated Phase 4 Results

• 2 other identifiers: STU00085782R01DK100924-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Keywords

Interstitial cystitis with Painful Bladder Syndrome; Urological Chronic Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

D-Cycloserine and Acetominophen

EXPERIMENTAL

D-cycloserine 200mg/bid and Acetaminophen prn

Drug: D-Cycloserine

Placebo and Acetominophen

PLACEBO COMPARATOR

Placebo capsules (lactose)/bid and Acetaminophen prn

Drug: Placebo (for D-cycloserine)

Interventions

D-Cycloserine DRUG

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

Also known as: Seromycin

D-Cycloserine and Acetominophen

Placebo (for D-cycloserine) DRUG

Lactose filled capsules to mimic DCS 200mg capsules

Also known as: Tylenol

Placebo and Acetominophen

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prostatitis

Interventions

Cycloserine; Acetaminophen

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The study was closed due to recruitment limitations. Given the challenges in recruitment, the investigators decided to terminate the study.

Results Point of Contact

• Title: Camila Bonin Pinto, PhD
• Organization: Northwestern University

camila.pinto@northwestern.edu

3125033971

Study Officials

• Vania Apkarian, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 11, 2015
• Study Start: September 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)