A Double-Blind, Randomized, Placebo-Controlled Study of Calcium Glycerophosphate Dietary Supplement in Patients with Ove

1. A Double-Blind, Randomized, Placebo-Controlled Study of Calcium Glycerophosphate Dietary Supplement in Patients with Overactive Bladder Michael J. Kennelly, MD Robbin Clark, RN Marvin S. Medow, PhD McKay Department of Urology Carolinas Medical Center Charlotte, NC

2. Risk Factors for Urinary Incontinence

3. Dietary Irritants Alcoholic beverages Caffeinated products Citrus juice and fruits Tomatoes and tomato-based products Highly spicy foods Artificial sweeteners

4. Purpose To evaluate the efficacy of calcium glycerophospate dietary supplement (Prelief®) in patients with overactive bladder (OAB) To evaluate patient acceptance and satisfaction with Prelief®

5. Study Design Prospective, randomized, single-center, double-blind, placebo-controlled 3 weeks study duration on Prelief® or placebo Two study tablets were taken TID daily with meals Placebo was identical to the active product with respect to size, color, and odor IRB approved

6. Study Design Double-blind Placebo controlled Single center 60 patients enrolled 4 week study with 3 weeks of treatment on Prelief® or placebo 2 tablets TID with meals Placebo identical to Prelief® in size, shape, color. IRB approved

7. Inclusion Criteria > 18 years of age with OAB OAB defined as: Urinary Frequency > 8 voids on average/24 hours Urgency Urge Incontinence > 1 UUI episode/24 hours confirmed on micturition chart Stable OAB medications continued throughout the study

8. Exclusion Criteria Mixed incontinence with 1° symptom is SUI Acute UTI in run-in period Known treatable GU condition UTI, prostatitis, BOO, TCCA, bladder stone, prostate cancer, radiation therapy to pelvis Uninvestigated hematuria Indwelling foley, SPT, or on CIC Known allergy or hypersensitivity to Prelief®

9. Analysis of Efficacy Data Objective Assessment 3-day voiding diary Mean # voids/24 hr Mean # nocturia/24 hr Mean # incontinent episodes/ 24 hr Mean # of pads used/ 24 hr Subjective Assessment Perception degree of Urgency Incontinence Impact Questionnaire (IIQ) Satisfaction scale Questionnaires

10. Demographics

11. Demographics

12. Mean Reduction in Frequency and Nocturia at 3 weeks

13. Mean Reduction in Urge Incontinent Episodes and Number of Pads Used

14. Patient Perception of Urgency at 3 Weeks I was usually not able to hold urine at all I was usually able to hold urine until I reached a toilet (without leaking) if I went there immediately I was usually able to finish what I was doing before going to the toilet (without leaking)

15. Patient Satisfaction at 3 weeks How well has this therapy worked for you OAB? Not at all Poor Fair Good Very Good Excellent

16. Patient Satisfaction at 3 Weeks How pleased have you been with this therapy for you OAB? Extremely displeased Very displeased A bit displeased Pleased Very pleased Extremely pleased

17. Patient Satisfaction at 3 weeks How much have you benefited from this therapy for your OAB problem? Not at all A little bit Some A lot

18. Patient Satisfaction at 3 weeksMean values for Worked, Pleased, & Benefited

19. Mean Reduction in IIQ-7 Questions

20. IIQ-7 Short Form at 3 weeks

21. IIQ Results at 3 weeks Mean reduction in IIQ-7 Total Score Placebo 9.16 Prelief® 17.33 Most improvements in Ability to socialize Quantity of sleep Ability to go places Ability to wear clothes Performance of exercises Ability to attend entertainment

22. Conclusions Prelief® did not show any significant improvements in voiding diary data. Trend in reduction of urinary frequency & nocturia Patients noted significant QOL improvements on Prelief® Worked p= 0.026 Pleased p=0.034 Benefited p=0.0143

23. Conclusions Mechanism by which spicy and acidic foods exacerbate OAB symptoms is unknown Theory is sensitization of sensory afferent nerves of urothelium Many OAB patients are food sensitive and can identify bladder irritants Consequently, if OAB patients are acid food sensitive, Prelief® is safe and efficacious in subjective improvement of symptoms and QOL

24. A Double-Blind, Randomized, Placebo-Controlled Study of Calcium Glycerophosphate Dietary Supplement in Patients with Overactive Bladder Realize that many OAB patients are food sensitive and can identify bladder irritants. Council your OAB patients on dietary modification. Understand the mechanism by which spicy and acidic foods exacerbate OAB symptoms is unknown. Theory is sensitization of sensory afferent nerves of urothelium. Do not use calcium glycerophosphate to dramatically change objective voiding diary data (frequency, urgency, or urge incontinence). If OAB patients want a non-Rx alternative to improve subjective symptoms and quality of life, consider calcium glycerophosphate dietary supplement for those OAB patients who are acid food sensitive.