Clinical Results For Bladder Control

Question 1

What is the difference between Standard and Recommendation?

Answer 1

Standard: Directive statement that an action should be taken because benefits outweigh risks/burdens with an evidence level of Grade A or Grade B evidence required

Recommendation: directive statement that an action should be taken because benefits outweigh risks/burdens with an evidence level of Grade C evidence

Question 2

In MDT-103, what % of interstim retention patients had at least 50% improvement in the volume/catheterizations in the evaluator and intent-to-treat data at 5 years?

Answer 2

78% and 58%

Question 3

In MDT-103, what % of interstim urge incontinent OAB patients had at least a 50% reduction in leaks/day in the evaluable and intent-to-treat data at 5 years?

Answer 3

71% and 42%

Question 4

According to the Insite phase 1 data, what % of OAB patients showed a greater than 50% improvement when comparing SNM with SMT in the as-treated population?

Answer 4

76% and 49%

Question 5

In the Insite phase I data, interstim has _________ over OAB medications at 6 months.

Answer 5

3x greater QOL improvement

Question 6

The Insite phase II data found that ______ of OAB patients achieved >=50% improvement and ____ of UI patients were completely continent

Answer 6

82% and 45%

Question 7

According to the AUA/SUFU guideline, which 3rd line advanced therapies are listed as recommendations in the 2014 review?

Answer 7

SNM and PTNM