Transcript A Double-Blind, Randomized, Placebo-Controlled

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
Risk Factors for Urinary Incontinence
Promoting Factors
Predisposing Factors
Gender
Genetics
Race
Culture
Neurology
Anatomy
Collagen Status
Inciting Factors
Childbirth
Surgery
Pelvic Nerve Damage
Radiation
Bowel Dysfunction
Dietary Irritants
Activity Level
Obesity
Menopause
Infection
Medication
Pulmonary Status
Psychiatric Status
Dietary Irritants
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
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Alcoholic beverages
Caffeinated products
Citrus juice and fruits
Tomatoes and tomatobased products
Highly spicy foods
Artificial sweeteners
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®
Study Design
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Prospective, randomized, single-center, doubleblind, 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
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
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confirmed on micturition chart
Stable OAB medications continued throughout
the study
Exclusion Criteria
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Mixed incontinence with 1° symptom is SUI
Acute UTI in run-in period
Known treatable GU condition
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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®
Analysis of Efficacy Data
Objective Assessment
3-day voiding diary
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Mean # voids/24 hr
Mean # nocturia/24 hr
Mean # incontinent
episodes/ 24 hr
Mean # of pads used/ 24
hr
Subjective Assessment
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Perception degree of
Urgency
Incontinence Impact
Questionnaire (IIQ)
Satisfaction scale
Questionnaires
Demographics
Sex (%)
Male
Female
Mean Age (years)
Range
Race (%)
White
Black
On OAB meds (%)
Previous OAB therapy
Placebo
(n=29)
Prelief®
(n=29)
7%
92%
62
28-86
27%
72%
63
30-85
93%
7%
31%
86%
100%
0%
9%
54%
p value
p=0.078
p=0.99
p=0.49
Demographics
Placebo
(n=29)
Prelief®
(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
1.34 (1.20)
1.66 (2.62)
* all p values > 0.01
Mean Reduction in Frequency and
Nocturia at 3 weeks
0.6
(p=0.65)
(p=0.24)
0.5
0.4
Placebo
Prelief
0.3
0.2
0.1
0
Frequency
Nocturia
Mean Reduction in Urge Incontinent
Episodes and Number of Pads Used
1.2
(p= 0.41)
(p=0.70)
1
0.8
Placebo
Prelief
0.6
0.4
0.2
0
Urge Incontinence
# Pads Used
Patient Perception of Urgency at 3 Weeks
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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)
40%
35%
30%
25%
Placebo
Prelief
20%
15%
10%
5%
0%
Improvement
Patient Satisfaction at 3 weeks

Go
od
oo
d
G
Fa
ir
Ve
ry
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Po
or
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Al
l

at
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45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
N
ot
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How well has this
therapy worked for you
OAB?
Not at all
Poor
Fair
Good
Very Good
Excellent
Placebo
Prelief
Patient Satisfaction at 3 Weeks
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ry
Ve
Prelief
P
ed
DP
DP
Placebo
s
ea
Pl
t
Bi
ry
Ve

DP
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50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
.
Ex

How pleased have you
been with this therapy
for you OAB?
Extremely displeased
Very displeased
A bit displeased
Pleased
Very pleased
Extremely pleased
Patient Satisfaction at 3 weeks
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How much have you
benefited from this
therapy for your OAB
problem?
Not at all
A little bit
Some
A lot
60%
50%
40%
30%
20%
10%
0%
Not at A little Some
All
Bit
Placebo
A Lot
Prelief
Patient Satisfaction at 3 weeks
Mean values for Worked, Pleased, & Benefited
4
3.5
(p=0.026)
(p=0.034)
(p=0.0143)
3
2.5
Placebo
Prelief
2
1.5
1
0.5
0
Worked
Pleased
Benefited
IIQ Results at 3 weeks
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90%
80%
70%
60%
50%
40%
30%
Mean reduction in IIQ-7
Total Score
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Improve
Same
Placebo
Worse
Prelief
9.16
17.33
Most improvements in
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20%
10%
0%
Placebo
Prelief®
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Ability to socialize
Quantity of sleep
Ability to go places
Ability to wear clothes
Performance of exercises
Ability to attend entertainment
Conclusions
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Prelief® did not show any significant
improvements in voiding diary data.
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Trend in reduction of urinary frequency & nocturia
Patients noted significant QOL improvements
on Prelief®
Workedp= 0.026
 Pleased
p=0.034
 Benefited
p=0.0143
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Conclusions
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Mechanism by which spicy and acidic foods
exacerbate OAB symptoms is unknown
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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
A Double-Blind, Randomized, Placebo-Controlled Study of
Calcium Glycerophosphate Dietary Supplement in Patients
with Overactive Bladder
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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.