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Transcript of October 2010 PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022...
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
1
Effectiveness of a jell absorbent pad in
moderate to severe urinary incontinence
Submitted to
Tisteron LTd.
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
2
Contents
1. Objectives & Methodology………………………………………………………3
2. Executive’s
Summary…........................................................................9
3. USIQ 17 Before & After PeeRelief use……………………………………..18
4. Affect of Urinary Incontinence on Quality of Life……………………….25
5. Means of coping with urinary incontinence before PeeRelief
use...30
6. Probability of buying and adopting the PeeRelief………………..……34
7. Appendix………………………………………………………………………….40
8. Characteristics of the Sample……………………………………………….58
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
3
Objectives &
Methodology
1
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20104
Background
Men and women with moderate to severe urinary incontinence, who have tried all possible treatments, or to whom medicinal treatment and operation are contra-indicated, use nowadays cumbersome diapers that limit their ability to use proper clothes, or confines them to perpetually stay within the reach of a bathroom.
Such circumstances call for a search of new solution that may provide the benefit of freeing those with moderate incontinence from chaging pads several times a day or staying constantly very near toillets, as well as freeing those with severe incontinence from using cumbersome diapers.
A larger jell containing pad was developped, suitable to absorb up to half a litter liquid, it elliminates odors and enables the users to wear ordinary clothes . It was presented for clinical trial.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20105
Objectives The objectives of the clinical trial, proposed hereafter, is to assess to what extent the new jell pad presents an advantage over the existing means of coping with urinary incontinence in cases when medicinal treatment or surgery is not appropriate.The purpose of the proposed study was to test the effect of the new jell pad on the quality of life of urinary incontinent men and women and to assess, to what extent the jell pad improves the quality of life of incontinent persons.
Initial Study Design approved by The Human investigation committee approval at Rabin Medical Centre:
Study Type: Interventional Treatment design: Non-Randomized, Open Label, Uncontrolled,
Single Group Assignment, Efficacy Study Estimated Enrollment: 90 patients.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20106
Eligibility Inclusion Criteria:
Urinary incontinent women and men who loose urine at a quantity higher than drops (50CC or more).
Three segments of such persons were supposed to be included in the study:
30 pregnant women who are temporary urinary incontinent30 women of the age 40+ who are urinary incontinent30 men who are urinary incontinent (post prostatectomy)
Exclusion criteria:Urinary incontinent disabled patients who need nursing.Patients who presently have cancer of any kind.
Study ProtocolVisit 0-1 :First screening and eligibility was to be determined.
Eligible patients were told about the study objectives and methodology and those who agreed to participate, signed an informed consent.Each of the patients enrolled to the study filled out a USIQ consisted of urinary functioning questionnaire and Quality of life questionnaire.
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October 20107
Each of the participants filled out a diaryEach patient was given 4 pads per day for entire use of 4 days The participants were requested to bring with them on the next visit all used pads, so that the used pads will be weighted.
Visit 2: Two weeks later- Basic efficacy assessmentIn which the following actions were performed:The patient filled out a USIQ questionnaire The pads were weighted.Incidence of allergic events associated with the adhesive part of the pad, as well as, difficulty in fixing pad in the appropriate place were assessed.During this visit price sensitivity was measured as well as probability of usage and acquisition patterns were assessed.
After 4 month the client decided to discontinue the clinical trial due to very slow enrollment and analyze findings of 16 patients only, instead of the initial sample of 90 patients. The results are presented in the following.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20108
Methodology (Description of patients who actually participated in the study)The study was performed in 6 centers: 3 women’s centers, which belong to Clalit Health Services (Kiryiat Ono, Concord in Ramat-Gan, and Ezra in Bnei-Braq), Urologic Clinic and Uro-gynecological clinic at Rabin Medical Centre in Petach- Tiqwa and an Elderly Citizen’s home in Tel Aviv. Most participants were actually enrolled in both clinics at Rabin Health Centre, and only one woman was enrolled in Bnei-Braq. In the elderly citizen’s home in Tel Aviv 12 urinary incontinent residents were guided how to use the Peerelief and then, they refused to enter the study when they realized that they would need to stick the Peerelief to their skin. In this trial 16 patients participated, 10 women (67%) and 5 men (33%) and 1 of whom the gender was not reported. Women’s age was 50-70, while the average was 68 years. Men’s age was 70-80, while the average was 76. Most participants had 11 years of education. Their monthly family income mode was 7000NIS (about $2000). Half of the participants were secular and 1/3 religious, the rest did not report.
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
9
Executive’s Summary 2
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201010
USIQ - A Before- After comparison - Selected Findings
In general, participants have moderate to severe urge to urinate. Among men, duration of time from the moment the urge was felt, until urinating, slightly increased on using the Peerelief (1-5 minutes ), whereas among women duration of time from the moment the urge was felt, until urinating, decreased while using the Peerelief. It seems that women felt that they have “a place” for urinating. Men felt less confident with using the Peerelief thus their duration of time slightly increased.
Among women the urge to urinate disturbed them less, while using the Peerelief, whereas among men the urge disturbed more while using the Peerelief, probably because they felt inconvenience both in using and removing it.
Urinating frequency decreased by ¼ of an hour among men, while using the Peerelief (from every 1.15 hour to 1 hour and a half, on the average).
Among women, urinating frequency increased by ¼ of an hour on the average, while using the Peerelief (from every hour to every ¾ of an hour, on the average.)
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201011
Evaluation of perceived Health Status and Quality of Life Before and After Peerelief use
Quality of life, among all participant, increased after use of Peerelief, mainly because it enabled them to have intimate relations, and it also enabled the participants to take part in leisure activities (among both men and women). Among men there is an improvement in the ability to work and to partake in outdoor social activity. Among women there is an improvement in the ability to do physical exercise and in the feeling of frustration.
When all participants were asked to report about their Health Status on a scale from 0 to 100, an increase of 23% was recorded after using the Peerelief,(from an average of 59 to 73) , among both men & women.
Comparison of Peerelief to the means used earlier
Before the use of Peerelief most participants used other means to cope with their urinary incontinence; women used pads and men used padded disposable underwear or diapers. A quarter of the participants did not go farer than half an hour from their home or a place with a toilet. Most of the participants always used the above mentioned means.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201012
Average monthly expenditure on means to control urinary incontinence is 343NIS, men spend 475NIS mainly on padded disposable underwear and diapers and women spend 275NIS on pads.
On comparing Peerelief use to the use of other means, we found that the Peerelief has an advantage mainly among women in all the characteristics measured except the burning sensation on removing the Peerelief.
Men, on the other hand, reported about inconvenience wearing the Peerelief, burning, and a damp and unpleasant sensation associated with the Peerelief more than with the other means that they use. In the parameters : odor elimination, and frequency of changing the Peerelief has advantages over other existing means.
After the use of Peerelief, 4 out of 10 women reported that it absorbs well 20% reported that it provides them with a sense of confidence and one women said that it is thin and well adheres to the body. Yet 20% of the men and 20% of the women reported that the Peerelief is inconvenient, 1 women reported sensitivity to the adhesive and 30% of the participants said that the Peerelief has no advantage over other means. 3 out of 5 men reported that the adhesive part cannot be used again after it gets wet, it is difficult to put on the Peerelief and it disturbs them while walking.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201013
Weighting & Diary information
The average weight of a used Peerelief is 118.3 grams (124 grams among men and 111 grams among women). Average duration of time changing/removing the Peerelief – 5.7 hours.
The diary data shows that the Peerelief needs adaptation time; at the beginning, with the first Peerelief, users feel more uncomfortable, frequency of changing the Peerelief is high, it leaks and there is a damp sensation but with the use of the second and third Peereleifs there is an improvement in the convenience to put on, use and remove it, there is no damp sensation and the odor is eliminated.
Still, the inconvenience in use of the Peerelief is evident in its removal- 71% of the users (including 57% of the women, complained about difficulty in removal due to the adhesive area (“like the removal of a bandaid” ,“it pulls the skin”) and the fact that the adhesive caused sensitivity and rash which, in one case brought about discontinuation of the trial.
29% of the participants complained about leaking of urine and inconvenience in use.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201014
Market Potential & target market
Most of the older women (above the age of 65) showed willingness to use the Peerelief (said they will use it “to a great extent -50%/ to a very great extent - 10%”). In contrary, most men- 60% said “they will not use it at all”, and none of the men reported any positive probability of using the Peerelief.
The reasons for unwillingness to use the Peerelief among men are inconvenience on the one hand and the availability of other means of controlling urinary incontinence, means, over which the Peerelief has no advantages.
Apart of inconvenience men complained about the size of the circle in which the penis is inserted as being either too big or too small, and about the adhesive, which caused sensitivity, did not stick again after getting wet, as well as, general inconvenience while walking.
1/5 of the women are ready to pay 5NIS ($1.35) for one Peerelief and 10% are ready to pay 7.5NIS ($2). Men were not ready to pay any price at all.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201015
Summary & Recommendations It is evident that the Peerelief is better than other products for urinary
incontinence, which exist on the market. For both men and women, it provides confidence in intimate relations and enables the users to take part in social activity outdoors and to do physical activity, but with respect to marketing potential, the product, as is, is suitable mainly to older women (above the age of 65).
The main problem that is evident stems from the fact that the product must be adhered to the skin, and actually it is glued to the skin, in a very sensitive and problematic part of the body, which entails skin problems, as well as psychological inconvenience, especially while removing. Secondly is, the adhesive material itself that causes in some cases, sensitivity and rash, and mechanically when wetted it does not adhere again. A third problem arises among men, for some of them the location where the penis is inserted is either too small or too big. Thus it is recommended to redesign the Peerelief, in a mode that will not require to glue it to the skin. Create very thin disposable underwear in which only the lower part would be made of the Peerelief material. In addition, to create the product differently for men and women and include several sizes (at least from S to XL).
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201016
In addition one has to consider the fact that the product, as designed today needs at lease 1 day of adaptation in which at least 4 Peereliefs would be used.
It is not possible to get any reasonable conclusions about market potential based on such a small sample of participants, yet the main problems with the product that one has to account for, while improving it, have bee well studied and well addressed.
To conclude:The Peerelief is advantageous in the abilities of absorption and elimination of odors, characteristics which are extremely important in such a product as these are the ones which improved participants’ Quality of Life and Health Status.In order to market the Peerelif to a large market segment it calls for remodeling:
Find a new solution for wearing the Peerelief without contact of adhesive to skin. Could be a mesh made disposable underwear, designed to be comfortable while walking, and doing physical activity, which would be offered in several sizes.
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
17
Main Findings
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
18
USIQ ResultsBefore & After 3
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201019
10
.0%
70
.0%
20
.0%
6.3
% 18
.8%
50
.0%
25
.0%
20
.0%
40
.0%
40
.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
Irrelevant In a part of urinating instances In most of the times that Iurinated
In practically all instances ofurinating
1. During the last week, in how many instances of urinating have you experienced urge ?
10.0
%
30.0
% 40.0
%
20.0
%
6.7
%
20.0
%
20.0
% 26.7
%
26.7
%
40.0
%
40.0
%
40.0
%
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
0.45
Never In a part of urinatinginstances
In half of theurinating instances
In most urinatinginstances
Practically in allurinating instances
N=5 Men Women N=10 Total N=15
`
BeforeBefore
AfterAfter
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201020
10
.0%
30
.0%
20
.0%
40
.0%
6.3
% 12
.5%
31
.3%
18
.8%
31
.3%
40
.0%
20
.0%
20
.0%
20
.0%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
40.0%
45.0%
Irrelevant Slight Moderate Severe Very severe
2. When you feel urge to urinate, is it:
40.0
%
30.0
%
30.0
%
6.7
%
40.0
%
20.0
%
33.3
%
40.0
%
40.0
%
40.0
%
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
0.45
Slight Moderate Severe Very severe
Men N=5 Women N=10 Total N=15
`
BeforeBefore
AfterAfter
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October 201021
10
.0% 2
0.0
% 30
.0%
20
.0%
20
.0%
6.3
%
6.3
%
18
.8%
25
.0%
25
.0%
18
.8%
20
.0%
40
.0%
20
.0%
20
.0%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
40.0%
45.0%
Irrelevant Half an hour Less than half anhour and more than 5
minutes
Less than 5 minutes& more than 1 minute
Less than 30secondes
Cannot wait at all
3. For how long can you wait , from the moment you feel the urge until you urinate?
10.0
%
30.0
%
10.0
%
10.0
%
40.0
%
7.1
%
28.6
%
28.6
%
7.1
%
28.6
%
25.0
%
75.0
%
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
Half an hour Less than half an hourand more than 5
minutes
Less than 5 minutes &more than 1 minute
Less than 30secondes
Cannot wait at all
Men N=5,4 Women N=10 Total
`
BeforeBefore
AfterAfter
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201022
20
.0%
10
.0%
70
.0%
6.3
%
6.3
% 18
.8%
6.3
%
62
.5%
20
.0%
40
.0%
20
.0%
20
.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
Irrelevant Slghitly Moderately Significantly Very much
4. During last week, to what extent did the urge to urinate disturb you?
20.0
%
20.0
%
60.0
%
7.1
%
21.4
%
14.3
%
57.1
%
25.0
%
50.0
%
25.0
%
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
Slghitly Moderately Significantly Very much
N=4,5 Men Women N=10 Total
`
BeforeBefore
AfterAfter
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201023
10
.0% 20
.0%
40
.0%
30
.0%
6.3
%
6.3
%
18
.8%
50
.0%
18
.8%
20
.0%
20
.0%
60
.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Irrelavant Seldom Sometimes Usually Always
5. In approximately 24 hours how frequent do you feel an urge to urinate?
30.0
%
30.0
%
40.0
%
21.4
%
35.7
% 42.9
%
50.0
%
50.0
%
0
0.1
0.2
0.3
0.4
0.5
0.6
Seldom Sometimes Usually Always
N=5,4 Men WomenN=10 Total
`
BeforeBefore
AfterAfter
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October 201024
65.0 63.8
75.0
93.8%
48.8
64.5
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
100.0
לפני אחרי
Men N=4 Women N=10 Total
6. How frequent do you feel an urge to urinate?
BeforeBefore AfterAfter
Averages in Minutes
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October 201025
Affect of UrinaryIncontinence on Quality of Life
4
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October 201026
3.9
3.7
3.2
3.1
1.6
1.6
3.8
3.7
3.4
3.3
1.7 1.8
3.8
1.3
3.8
3.8
3.6
1.8
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
Frequent urinating Leakage associated withthe urge to urinate
Urinary leakage duringphysical activity
Small quantities or dropsof urinary leakage
Difficulty in emptying thebladder
Pain or inconvenience inthe lower abdomen or
crotch
7. To what extent do you feel, and if you feel, to what extent does it disturb you:3.6
3.6
3.1
3.1
2.3
2.0
3.5 3.6
3.3 3.4
1.9
1.9
3.8
1.0
3.3 3.5 3
.8
1.7
0
0.5
1
1.5
2
2.5
3
3.5
4
Frequent urinating Leakage associated withthe urge to urinate
Urinary leakage duringphysical activity
Small quantities or dropsof urinary leakage
Difficulty in emptying thebladder
Pain or inconvenience inthe lower abdomen or
crotch N=3-5 Men Women N=8-10 Total
`
BeforeBefore
AfterAfter
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October 201027
3.4 3.6
3.0
3.7
3.4
3.4 3
.9 4.1
3.8
3.4
3.4 3
.9
3.3 3.6 3.9 4.0
3.6
3.6
5.0
2.8
4.5
3.0
4.0
3.6
0
1
2
3
4
5
6
Your ability towork
Your ability to dophysical exercise
Your ability to be inintimate relations
Your leisureactivity (go to a
film, concert)
The ability totravel by car or
bus to a distancelonger than 30
minutes
Your ability topartake in socialactivity outdors
On your feelings,whether you feel
angry ordepressed
On your feelings;do you feelfrustrated?
8. To what extent the urge to urinate affects:
3.1
3.1
2.5
3.0
3.4 3.5
3.8
3.6
3.4
3.2
2.9 3.0
3.3 3.4
3.7
3.7
3.2
3.0
3.4
3.8
3.0
3.3 3
.6
4.0
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
Your ability towork
Your ability to dophysical exercise
Your ability to bein intimaterelations
Your leisureactivity (go to a
film, concert)
The ability totravel by car or
bus to a distancelonger than 30
minutes
Your ability topartake in socialactivity outdors
On your feelings,whether you feel
angry ordepressed
On your feelings;do you feelfrustrated?
N=4,5 Men Women N=8,9 Total
`
BeforeBefore
AfterAfter
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October 201028
59.2
72.9
47.5
66.0
76.7
65.0
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
לפני אחרי
Men N=4,5 Women N=8,9 Total
13. On a scale from 0 to 100, if 0=death, and 100=perfect health, where would be your state of health?
BeforeBefore AfterAfter
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October 201029
3.6
3.6
3.0
2.4
1.9
1.8
1.6
2.7
2.4
3.4
3.4
3.4
2.3
2.1
1.7
1.5
3.1
2.5
3.5
2.2
3.6
1.6
1.4
2.8
3.8
2.0
1.4
0
0.5
1
1.5
2
2.5
3
3.5
4
Dampness orhumidity on the
skin
Unpleasant odor Rash Pain orsensitivity of
skin
Burning whileurinating, afterPeerelief use
A local infection An unpleasantfeeling
Inconveniencywhile wearingthe Peerelief
A need tofrequentlychange thePeerelief
12. To what extent have you felt each of the following:
3.3
3.0
1.6
1.4
1.4
1.4
1.4
1.0
1.3
2.1
1.6
2.3
2.1
2.0
1.4
1.4 1
.6
1.2
1.7
2.5
2.1
2.6
1.4
1.4
3.0
3.2
1.8
1.4
2.5
3.3
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
Dampness orhumidity on
the skin
Unpleasantodor
Rash Pain orsensitivity of
skin
Burning whileurinating, afterPeerelief use
A localinfection
An unpleasantfeeling
Inconveniencywhile wearingthe Peerelief
A need tofrequentlychange thePeerelief
That it isdifficult to fixthe peerelief
N=4,5 Men Women N=8-10 Total
`
Before- Use of other means to control Before- Use of other means to control incontinenceincontinence
After- with the use of After- with the use of PeereliefPeerelief
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
30
Antecedent MeansUsed to Cope with
Incontinence5
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201031
53.3
%
13.3
%
20.0
%
6.7
%
62.5
%
31.3
%
25.0
%
12.5
%
12.5
%
6.7
%
20.0
%
13.3
%
13.3
%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
I use pads which exist today on the market
I use padded disposableunderwear
I keep staying within ahalf an hour reach of a
toilet
I keep staying within anhour reach of a toilet
I use diapers
Men N=5 Women N=10 Total
9. Which means do you use to cope with urinary incontinence
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201032
30.0%
70.0%
18.8%
81.3%
100.0%
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
120.0%
Usualy Always
Men N=5 Women N=10 Total
10. If you use a pad/padded underwear/diapers to cope with incontinence, do you use it:
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201033
200.0
350.0
216.7
437.5
375.0
800.0
250.0
375.0
0.0
100.0
200.0
300.0
400.0
500.0
600.0
700.0
800.0
900.0
Pads Diapers Padded pants
Men N=5 Women N=10 Total
11. If you use a pad/padded underwear/diapers to cope with incontinence, how much money do you spend per month on such means ?
Men’s Average expenditure 475 NIS
Women’s average Expenditure: 247NIS
Total average Expenditure: 247NIS
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
34
Probability of Buying & Adopting
the Peerelief6
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201035
10.0%
60.0%
20.0%
10.0%
10.0%
10.0%
20.0%
10.0%
10.0%
10.0%
20.0%
20.0%
40.0%
10.0%
10.0%
10.0%
50.0%
10.0%
10.0%
30.0%
20.0%
30.0%
30.0%
40.0%
0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0%
The penice extricated when there was a need to urinate
The Peerelief round opening is too small( a man)
It is thin
Causes inconvenience while walking/ inconvenient in general/ theadhesive is inconvenient
It is well attached
The adhesive part caused rash and sensitivity
The urine is leaking
It gives me confidence
The adhesive causes inconvenience, it does not stick properly
It has no advantage over other products which are on the market
It has good absorbance
Men N=4 Women N=6 Total
9. Please compare, the Peerelief that you have received for trial, to other means of protection that you use, and tell us about your feelings and opinion about it:
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201036
2.1
1.6
2.3
1.1
1.0
1.2
2.5
2.1
2.6
1.3
1.0
1.0
1.4
1.0
1.6
3.33.3
1.0
3.0
1.6
1.0
0
0.5
1
1.5
2
2.5
3
3.5
Wearing thePeerelief is
inconvinient
A frequent need tochange into a new
Peerelief
Difficulty in fixingand sticking the
PeeRelief
Irritation in theadhesive area
Rash & redness inthe adhesive area
Swelling & pain inthe adhesive area
Local tendernessand sensitivity inthe adhesive area
Men N=5 Women N=8,9 Total
10. To what extent do you feel each of the following?
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201037
10.0
%
10.0
%
10.0
%
50.0
%
10.0
%
10.0
%
26.7
%
13.3
%
13.3
%
33.3
%
6.7
%
6.7
%
0.0
%
0.0
%
0.0
%
20.0
%
20.0
%
60.0
%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Not at all Very Little Moderately To a great extent To a very great extent I do not know
Men N=5 Women N=10 Total
11. To what extent would you like to use this PeeRelief in the future, if at all?
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201038
16.7%
16.7%
16.7%
16.7%
16.7%
16.7%
16.7%
16.7%
16.7%
16.7%
16.7%
16.7%
16.7%
16.7%
33.3%
33.3%
0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0%
The adhesive is inconvenient, itdoes not stick when it is wet
It is too big
Inconveniency in walking
Glue sensitivity, causes rash
The adhesive circled area wherepenis is inserted is too small
Inconvenient
It has no advantage over othermeans of protection
Men N=4 Women N=2 Total
12. If you responded that you will not use the Peerelief in the future, why?
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20103939
I do not know 10%
Probably not, 30.0%
Probably yes, 30.0%
Definitely not, 30.0%
At the price of 10NIS per
unit($2.7) (N=10)
13-15. Would you buy this new PeeRelief, or not?
Definitely yes, 9.1%
I do not know9.1%
Probably not, 27.3%
Probably yes, 18.2%
Definitely not, 36.4%
Definitely yes 12.5%
I do not know, 12.5%
Probably not, 12.5%
Probably yes, 37.5%
Definitely not, 25.0%
At the price of 7NIS per unit($2)
N=11
At the price of 5NIS per
unit($1.35) n=8
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October 201040
Appendices 7
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
41
Peerelief Urine Weight
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20104242
Average weight of a used Peerelief (Grams)
0
100
200
300
400
500
Men N=1,3 108.5 152.6 159.1 103.0
Women N=5-8 105.9 101.5 116 123.6
Total 106.4 115.4 128.7 122.6
Day 1 Day 2 Day 3 Day 4
Average- Men – 124.4
Average- Women-111.8
General Average- 118.3
GRAMS
October 2010
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
43
Daily Usage Diary
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20104444
1 .To what extent is it convenient to adjust and stick the Peerelief?
N=8 N=8
1. Inconvenient1. Inconvenient2. Moderately convenient2. Moderately convenient3. Convenient3. Convenient
Peerelief No.
1-3 scale
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20104545
2 .Convenience while walking
N=7N=7
Peerelief No.
1. Inconvenient1. Inconvenient2. Moderately convenient2. Moderately convenient3. Convenient3. Convenient
1-3 scale
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20104646
3. Convenience 2 hours after applying the Peerelief
N=7N=7
1. Inconvenient1. Inconvenient2. Moderately convenient2. Moderately convenient3. Convenient3. Convenient
1-3 scale
Peerelief No.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20104747
4. Convenience after applying the Peerelief, while sitting
N=7N=7
1. Inconvenient1. Inconvenient2. Moderately convenient2. Moderately convenient3. Convenient3. Convenient
1-3 scale
Peerelief No.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20104848
5. Convenience after applying the Peerelief, while lying down
N=6N=6
1. Inconvenient1. Inconvenient2. Moderately convenient2. Moderately convenient3. Convenient3. Convenient
1-3 scale
Peerelief No.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20104949
6. Convenience after applying the Peerelief, while walking
N=7N=7
1. Inconvenient1. Inconvenient2. Moderately convenient2. Moderately convenient3. Convenient3. Convenient
1-3 scale
Peerelief No.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20105050
7. How long after applying the Peerelief have you removed it?
N= 5N= 5
Average duration until removed- 5.7 hoursAverage duration until removed- 5.7 hours
One measurement is missing One measurement is missing
1-10 scale
Peerelief No.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20105151
8. On changing the Peerelif, was there any leakage around the opening (% of affirmative answers
N=5N=5
Peerelief No.
Percent of those who answered affirmativelyPercent of those who answered affirmatively %YES
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October 20105252
9. Convenience of removing the Peerelief, in order to change it
N=6N=6
1. Inconvenient1. Inconvenient2. Moderately convenient2. Moderately convenient3. Convenient3. Convenient
1-3 scale
Peerelief No.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20105353
10. While changing the Peerelief was the odor eliminated, or not?
N=7N=7
Peerelief No.
%YES % %of responders who reported no odorof responders who reported no odor
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20105454
11. While changing was there any rash, sensitivity, swelling, burning, in the adhesive area?
N= 6N= 6
Peerelief No.
% %of responders who said “noof responders who said “no”” % NO
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20105555
11. While changing was there any rash, sensitivity, swelling, burning, in the 11. While changing was there any rash, sensitivity, swelling, burning, in the adhesive area?adhesive area?
N=6N=6 % %of responders who reported swelling of responders who reported swelling
twicetwice
Peerelief No.
% %of responders who reported “burningof responders who reported “burning”” % YES
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20105656
12. While changing was the skin dry or not?
N=7N=7
1. No1. No2. Moderately dry2. Moderately dry3. yes3. yes
1-3 scale
Peerelief No.
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 201057
14.3%
14.3%
14.3%
14.3%
14.3%
14.3%
14.3%
14.3%
28.6%
14.3%
57.1%
14.3%
14.3%
14.3%
14.3%
14.3%
14.3%
28.6%
28.6%
71.4%
0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0%
The penis extricated due to needto urinate
Sensitivity in the adhesive part,rash
Heavy
The Peerelief came apart
There was an odor
It falls
Uncomfortable
It leaks
Difficulty in removing- it sticks tothe skin
Men N=2 Women N=5 Total
13. If you said that it was uncomfortable to remove the Peerelief, for what reason?
October 2010
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58
Characteristics Of the Sample 8
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20105959
Feminine, 66.7%
Masculin, 33.3%
Gender
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October 20106060
Age of men (N=4)
61-70, 12.5%
71+, 50.0%
50-60, 37.5%
76-80, 50.0%
70-75, 50.0%
Age of women (N=4)
Average age of men: 76
Average age of women: 68
PharmaQuest ltd. 13 Kaplan St. Petach-Tiqwa, Tel.++972-3-6783057, Fax. ++972-3-6770022
October 20106161
High school, 40.0%
Technic school, 13.3%
Elementary school, 46.7%
Income
3-4 persons, 13.3%
5+ persons, 6.7%
1-2 persons, 80.0%
Education
7001 - 10000NIS,
10.0%
Up to 7000NIS, 90.0%
Household size
Average years of education: 11
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October 20106262
Traditional, 26.7%
Religious, 20.0%
Secular, 53.3%
Ethnicity
Of arab minority, 6.7%
New immigrant, 6.7%
Of western origin, 26.7%
Born in Israel secong generation,
6.7%
Of eastern origin, 53.3%
Religion
October 2010
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63
Thank You