a double-blind, randomized, placebo-controlled study of calcium glycerophosphate dietary supplement...
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![Page 1: A Double-Blind, Randomized, Placebo-Controlled Study of Calcium Glycerophosphate Dietary Supplement in Patients with Overactive Bladder Michael J. Kennelly,](https://reader035.vdocuments.us/reader035/viewer/2022062222/56649e9f5503460f94ba0c9d/html5/thumbnails/1.jpg)
A Double-Blind, Randomized, A Double-Blind, Randomized, Placebo-Controlled Study of Placebo-Controlled Study of Calcium Glycerophosphate Calcium Glycerophosphate
Dietary Supplement in Dietary Supplement in Patients with Overactive Patients with Overactive
BladderBladderMichael J. Kennelly, MDMichael J. Kennelly, MDRobbin Clark, RNRobbin Clark, RN
Marvin S. Medow, PhDMarvin S. Medow, PhDMcKay Department of UrologyMcKay Department of Urology
Carolinas Medical CenterCarolinas Medical CenterCharlotte, NCCharlotte, NC
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Risk Factors for Urinary Risk Factors for Urinary IncontinenceIncontinence
Predisposing FactorsGender
GeneticsRace
CultureNeurologyAnatomy
Collagen Status
Promoting FactorsBowel DysfunctionDietary Irritants
Activity LevelObesity
MenopauseInfection
MedicationPulmonary StatusPsychiatric Status
Inciting FactorsChildbirthSurgery
Pelvic Nerve DamageRadiation
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Dietary IrritantsDietary Irritants
Alcoholic beveragesAlcoholic beverages Caffeinated Caffeinated
productsproducts Citrus juice and Citrus juice and
fruitsfruits Tomatoes and Tomatoes and
tomato-based tomato-based productsproducts
Highly spicy foodsHighly spicy foods Artificial sweetenersArtificial sweeteners
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PurposePurpose
To evaluate the efficacy of calcium To evaluate the efficacy of calcium glycerophospate dietary supplement glycerophospate dietary supplement (Prelief®) in patients with (Prelief®) in patients with overactive bladder (OAB)overactive bladder (OAB)
To evaluate patient acceptance and To evaluate patient acceptance and satisfaction with Prelief®satisfaction with Prelief®
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Study DesignStudy Design
Prospective, randomized, single-center, Prospective, randomized, single-center, double-blind, placebo-controlleddouble-blind, placebo-controlled
3 weeks study duration on Prelief® or 3 weeks study duration on Prelief® or placeboplacebo
Two study tablets were taken TID daily Two study tablets were taken TID daily with mealswith meals
Placebo was identical to the active product Placebo was identical to the active product with respect to size, color, and odorwith respect to size, color, and odor
IRB approvedIRB approved
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Inclusion CriteriaInclusion Criteria
> 18 years of age with OAB> 18 years of age with OAB OAB defined as:OAB defined as:
Urinary Frequency > 8 voids on average/24 Urinary Frequency > 8 voids on average/24 hourshours
UrgencyUrgency Urge Incontinence > 1 UUI episode/24 Urge Incontinence > 1 UUI episode/24
hours hours confirmed on micturition chartconfirmed on micturition chart
Stable OAB medications continued Stable OAB medications continued throughout the studythroughout the study
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Exclusion CriteriaExclusion Criteria
Mixed incontinence with 1° symptom is SUIMixed incontinence with 1° symptom is SUI Acute UTI in run-in periodAcute UTI in run-in period Known treatable GU conditionKnown treatable GU condition
UTI, prostatitis, BOO, TCCA, bladder stone, UTI, prostatitis, BOO, TCCA, bladder stone, prostate cancer, radiation therapy to pelvisprostate cancer, radiation therapy to pelvis
Uninvestigated hematuriaUninvestigated hematuria Indwelling foley, SPT, or on CICIndwelling foley, SPT, or on CIC Known allergy or hypersensitivity to Known allergy or hypersensitivity to
Prelief®Prelief®
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Analysis of Efficacy DataAnalysis of Efficacy Data
Objective Objective AssessmentAssessment
3-day voiding diary3-day voiding diary Mean # voids/24 hrMean # voids/24 hr Mean # nocturia/24 Mean # nocturia/24
hrhr Mean # incontinent Mean # incontinent
episodes/ 24 hrepisodes/ 24 hr Mean # of pads Mean # of pads
used/ 24 hrused/ 24 hr
Subjective Subjective AssessmentAssessment
Perception degree Perception degree of Urgencyof Urgency
Incontinence Incontinence Impact Impact Questionnaire (IIQ)Questionnaire (IIQ)
Satisfaction scale Satisfaction scale QuestionnairesQuestionnaires
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DemographicsDemographics
Placebo Prelief® p value
(n=29) (n=29)Sex (%) Male 7% 27% Female 92% 72%p=0.078Mean Age (years) 62 63 Range 28-86 30-85
p=0.99Race (%) White 93% 100% Black 7% 0%p=0.49On OAB meds (%) 31% 9%Previous OAB therapy 86% 54%
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DemographicsDemographics
Placebo Prelief®(n=29) (n=29)
Mean voids/24 hr 11.2 (2.84) 11.5 (3.49)
Mean nocturia/24 hr 1.31 (1.69) 1.55 (1.06)
Mean # incontinent/24 hr 2.72 (3.42) 3.07 (5.07)
Mean # pad/24 hr 1.66 (2.62) 1.34 (1.20)
* all p values > 0.01
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Mean Reduction in Mean Reduction in Frequency and Nocturia at Frequency and Nocturia at
3 weeks 3 weeks
0
0.1
0.2
0.3
0.4
0.5
0.6
Frequency Nocturia
PlaceboPrelief
(p=0.65) (p=0.24)
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Mean Reduction in Urge Mean Reduction in Urge Incontinent Episodes and Incontinent Episodes and
Number of Pads UsedNumber of Pads Used
0
0.2
0.4
0.6
0.8
1
1.2
Urge Incontinence # Pads Used
PlaceboPrelief
(p= 0.41) (p=0.70)
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Patient Perception of Urgency Patient Perception of Urgency at 3 Weeksat 3 Weeks
I was usually not able I was usually not able to hold urine at allto hold urine at all
I was usually able to I was usually able to hold urine until I hold urine until I reached a toilet reached a toilet (without leaking) if I (without leaking) if I went there went there immediatelyimmediately
I was usually able to I was usually able to finish what I was finish what I was doing before going to doing before going to the toilet (without the toilet (without leaking)leaking)
0%
5%
10%
15%
20%
25%
30%
35%
40%
Improvement
PlaceboPrelief
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Patient Satisfaction at 3 Patient Satisfaction at 3 weeksweeks
How well has this How well has this therapy therapy workedworked for you OAB?for you OAB?
Not at allNot at all PoorPoor FairFair GoodGood Very GoodVery Good ExcellentExcellent
0%5%
10%15%20%25%30%35%40%45%
Not at
All
Poor
Fair
Good
Very Goo
d
Placebo Prelief
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Patient Satisfaction at 3 Patient Satisfaction at 3 WeeksWeeks
How How pleasedpleased have have you been with this you been with this therapy for you therapy for you OAB?OAB?
Extremely displeasedExtremely displeased Very displeasedVery displeased A bit displeasedA bit displeased PleasedPleased Very pleasedVery pleased Extremely pleasedExtremely pleased
0%5%
10%15%20%25%30%35%40%45%50%
Ex. DP
Very DP
Bit DP
PleasedVery P
Placebo Prelief
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Patient Satisfaction at 3 Patient Satisfaction at 3 weeksweeks
How much have How much have you you benefitedbenefited from this therapy from this therapy for your OAB for your OAB problem?problem?
Not at allNot at all A little bitA little bit SomeSome A lotA lot
0%
10%
20%
30%
40%
50%
60%
Not atAll
A littleBit
Some A Lot
Placebo Prelief
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Patient Satisfaction at 3 Patient Satisfaction at 3 weeksweeks
Mean values for Worked, Pleased, & Mean values for Worked, Pleased, & BenefitedBenefited
0
0.5
1
1.5
2
2.5
3
3.5
4
Worked Pleased Benefited
PlaceboPrelief
(p=0.026) (p=0.034) (p=0.0143)
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IIQ Results at 3 weeksIIQ Results at 3 weeks Mean reduction in IIQ-7 Mean reduction in IIQ-7
Total Score Total Score PlaceboPlacebo 9.169.16 Prelief®Prelief®
17.3317.33
Most improvements in Most improvements in Ability to socializeAbility to socialize Quantity of sleepQuantity of sleep Ability to go placesAbility to go places Ability to wear clothesAbility to wear clothes Performance of exercisesPerformance of exercises Ability to attend Ability to attend
entertainmententertainment
0%
10%
20%
30%
40%50%
60%
70%
80%
90%
Improve Same Worse
Placebo Prelief
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ConclusionsConclusions
Prelief® did not show any significant Prelief® did not show any significant improvements in voiding diary data.improvements in voiding diary data. Trend in reduction of urinary frequency Trend in reduction of urinary frequency
& nocturia& nocturia
Patients noted significant QOL Patients noted significant QOL improvements on Prelief®improvements on Prelief® WorkedWorked p= 0.026p= 0.026 PleasedPleased p=0.034p=0.034 BenefitedBenefited p=0.0143p=0.0143
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ConclusionsConclusions Mechanism by which spicy and acidic Mechanism by which spicy and acidic
foods exacerbate OAB symptoms is foods exacerbate OAB symptoms is unknownunknown Theory is sensitization of sensory afferent Theory is sensitization of sensory afferent
nerves of urotheliumnerves of urothelium Many OAB patients are food sensitive Many OAB patients are food sensitive
and can identify bladder irritantsand can identify bladder irritants Consequently, if OAB patients are acid Consequently, if OAB patients are acid
food sensitive, Prelief® is safe and food sensitive, Prelief® is safe and efficacious in subjective improvement of efficacious in subjective improvement of symptoms and QOLsymptoms and QOL
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A Double-Blind, Randomized, Placebo-A Double-Blind, Randomized, Placebo-Controlled Study of Calcium Glycerophosphate Controlled Study of Calcium Glycerophosphate
Dietary Supplement in Patients with Dietary Supplement in Patients with Overactive BladderOveractive Bladder
Realize that many OAB patients are food sensitive and Realize that many OAB patients are food sensitive and can identify bladder irritants.can identify bladder irritants.
Council your OAB patients on dietary modification.Council your OAB patients on dietary modification. Understand the mechanism by which spicy and acidic Understand the mechanism by which spicy and acidic
foods exacerbate OAB symptoms is unknown. foods exacerbate OAB symptoms is unknown. Theory is sensitization of sensory afferent nerves of Theory is sensitization of sensory afferent nerves of
urothelium.urothelium. Do not use calcium glycerophosphate to dramatically Do not use calcium glycerophosphate to dramatically
change objective voiding diary data (frequency, change objective voiding diary data (frequency, urgency, or urge incontinence).urgency, or urge incontinence).
If OAB patients want a non-Rx alternative to improve If OAB patients want a non-Rx alternative to improve subjective symptoms and quality of life, consider subjective symptoms and quality of life, consider calcium glycerophosphate dietary supplement for calcium glycerophosphate dietary supplement for those OAB patients who are acid food sensitive.those OAB patients who are acid food sensitive.