Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis

The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score.

The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks") and a total score is normalized from 0 (worst) to 100 (best).

The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management.

Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).

Higher score indicates greater improvement.

The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks"), and a total score is normalized from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement.

The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 ("Never") to 4 ("Always") and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease.

The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).

The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments.

Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be).

Lower score indicates greater improvement.

A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure.