Last updated on March 2019

A clinical trial seeking patients for a research study for the treatment of Interstitial Cystitis, Bladder Pain Syndrome

Brief description of study

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain disorder involving the genitourinary tract. IC/BPS affects women more often than men. How the disorder develops is not completely known, but one thought is that IC/BPS is closely related to other chronic pain syndromes like irritable bowel syndrome and fibromyalgia. Although several options exist to treat IC/BPS, the therapy effects often don't last long. Studies in chronic pain disorders have shown that oral gabapentin is effective in relieving pain in these patients and some studies suggest that oral gabapentin also improves IC/BPS symptoms. The purpose of this study is to assess the effectiveness of oral gabapentin combined with bladder instillations in treatment of IC/BPS in women. The study hypothesis is that women with IC/BPS treated with bladder instillations and gabapentin will have improved outcomes compared to women treated with bladder instillations and placebo.

Detailed Study Description

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain disorder involving the genitourinary tract. IC/BPS disproportionately affects women, with women constituting over 80% of patients with IC/BPS. Like other chronic pain conditions, IC/BPS is physically and emotionally taxing on patients. IC/BPS costs the United States over $100 million annually due to direct healthcare costs and loss of worker productivity. The exact pathophysiology of the disease is unknown, leading to a limitation in our ability to treat the disorder effectively. The current leading etiologic theory is that IC/BPS is a neurologically-derived chronic systemic pain syndrome due to its association with musculoskeletal pelvic pain, irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and vulvodynia. Although several options exist to treat IC/BPS, therapeutic effects are often transient. Previous studies in chronic pain disorders have shown that multimodal treatment is more effective than single-agent treatment, so future therapy should aim to augment rather than replace current treatments. Gabapentin is a safe and cost-effective anti-epileptic medication that is commonly used to manage both acute and chronic pain. There are limited data to suggest that perioperative use of gabapentin potentiates analgesic effect and decreases the risk of developing chronic pain for up to six months after surgery. Gabapentin has even shown efficacy in bladder pain associated with catheters. Small clinical studies have demonstrated that oral gabapentin improves IC/BPS symptoms. Gabapentin is an effective adjuvant in treating general pain and likely helps prolong treatment effects, but it has not been trialed in this mode for IC/BPS. The knowledge gap that exists is whether gabapentin can improve patient response when used as an adjuvant treatment for IC/BPS symptoms.

To evaluate the utility of gabapentin in the treatment of IC/BPS, the study investigators propose a randomized, triple blind, placebo-controlled trial that will compare the efficacy of bladder instillations with and without adjuvant oral gabapentin on IC/BPS symptoms in women. The hypothesis is that combining oral gabapentin and bladder instillation therapy will result in a more robust treatment response than bladder instillations alone. This rationale is based on 1) the shared pathophysiology of chronic pain and IC/BPS, 2) the effectiveness of multimodal treatment in both chronic pain and IC/BPS, and 3) the success of gabapentin in the treatment of chronic pain.

Clinical Study Identifier: NCT03463915

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