NCT02385266

Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	D-Cycloserine	Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.
DRUG	Placebo (for D-cycloserine)	Lactose filled capsules to mimic DCS 200mg capsules

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-03-11
• Last updated: 2023-05-17
• Results posted: 2023-05-17

Locations

1 site across 1 country: United States