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Published on: December 9, 2015
The TRUST (EvaluaTion of Bladder Function in Relapsing-Remitting MUltiple Sclerosis Patients Treated with
Bhupendra O Khatri1, John F Foley1, Jennifer Fink1
1Center for Neurological Disorders and the Regional Multiple Sclerosis Center, Wheaton Franciscan Health Care, Milwaukee, WI, USA (BOK, JFK); Rocky Mountain Multiple Sclerosis Center, Salt Lake City, UT, USA (JFF); Aurora St. Luke's Medical Center, Milwaukee, WI, USA (JF); Elan Pharmaceuticals, Inc, San Francisco, CA, USA (CC); and Biogen Idec Inc, Cambridge, MA, USA (XY, JDW, PF). Dr. Warth is now with Genzyme Corporation, Cambridge, MA, USA.
Background:
Bladder dysfunction is a common symptom of multiple sclerosis (MS). This study was designed to evaluate effects of natalizumab on bladder function in patients with relapsing-remitting MS.
Methods:
The TRUST (EvaluaTion of Bladder Function in Relapsing-Remitting MUltiple Sclerosis Patients Treated with Natalizumab) study was an open-label, single-arm, two-center study. Natalizumab-naive MS patients with disabling bladder dysfunction and initiating natalizumab were enrolled and followed for 6 months. The primary endpoint was change in the Urogenital Distress Inventory short form (UDI-6) score from baseline. Change in Incontinence Impact Questionnaire short form (IIQ-7) score from baseline was a secondary endpoint.
Results:
Thirty patients were enrolled. Mean baseline characteristics were age 49.9 years, Expanded Disability Status Scale score 4.6, number of relapses in previous year 2.4, UDI-6 score 10.4, and IIQ-7 score 12.3. Mean changes in UDI-6 and IIQ-7 scores were significantly improved from baseline beginning at week 4 and up to week 24; mean improvements at 24 weeks were 4.4 (P < .0001) and 4.9 (P = .0005) points, respectively. At week 24, 85.7% and 78.6% of patients demonstrated improvements from baseline in UDI-6 and IIQ-7 scores, respectively.
Conclusions:
Incontinence-related quality of life as measured by UDI-6 and IIQ-7 scores improved significantly during natalizumab treatment.
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