Effectiveness of a jell absorbent pad in moderate to severe urinary incontinence

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Effectiveness of a jell absorbent pad in moderate
to severe urinary incontinence
Submitted to Tisteron LTd.
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• Contents
• Objectives Methodology3
• Executives Summary..............................
  ..........................................9
• USIQ 17 Before After PeeRelief
  use..18
• Affect of Urinary Incontinence on Quality of
  Life.25
• Means of coping with urinary incontinence before
  PeeRelief use...30
• Probability of buying and adopting the
  PeeRelief..34
• Appendix.40
• Characteristics of the Sample.58
  

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• Objectives
• Methodology

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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.
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• 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.

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• 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
  incontinent
• 30 women of the age 40 who are urinary
  incontinent
• 30 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 Protocol
• Visit 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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Each of the participants filled out a diary Each
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 assessment In
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.
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• Methodology (Description of patients who actually
  participated in the study)
• The study was performed in 6 centers 3 womens
  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 Citizens 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 citizens 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.
• Womens age was 50-70, while the average was 68
  years.
• Mens 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.

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• Executives
• Summary

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• 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.)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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).

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• 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.

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• Main Findings

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• USIQ Results
• Before After

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1. During the last week, in how many instances of
urinating have you experienced urge ?
Before
After
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2. When you feel urge to urinate, is it
Before
After
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3. For how long can you wait , from the moment
you feel the urge until you urinate?
Before
After
22
4. During last week, to what extent did the urge
to urinate disturb you?
Before
After
23
5. In approximately 24 hours how frequent do you
feel an urge to urinate?
Before
After
24
6. How frequent do you feel an urge to urinate?
Averages in Minutes
Before
After
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• Affect of Urinary
• Incontinence on Quality of Life

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25
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7. To what extent do you feel, and if you feel,
to what extent does it disturb you
Before
After
26
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8. To what extent the urge to urinate affects
Before
After
28
13. On a scale from 0 to 100, if 0death, and
100perfect health, where would be your state of
health?
Before
After
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12. To what extent have you felt each of the
following
Before- Use of other means to control incontinence
After- with the use of Peerelief
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• Antecedent Means
• Used to Cope with Incontinence

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9. Which means do you use to cope with urinary
incontinence
32
10. If you use a pad/padded underwear/diapers to
cope with incontinence, do you use it
33
11. If you use a pad/padded underwear/diapers to
cope with incontinence, how much money do you
spend per month on such means ?
Mens Average expenditure 475 NIS
Womens average Expenditure 247NIS
Total average Expenditure 247NIS
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• Probability of Buying Adopting the Peerelief

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35
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
36
10. To what extent do you feel each of the
following?
37
11. To what extent would you like to use this
PeeRelief in the future, if at all?
38
12. If you responded that you will not use the
Peerelief in the future, why?
39
13-15. Would you buy this new PeeRelief, or not?
At the price of 10NIS per unit(2.7) (N10)
At the price of 7NIS per unit(2) N11
At the price of 5NIS per unit(1.35) n8
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• Appendices

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• Peerelief Urine Weight

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Average weight of a used Peerelief (Grams)
GRAMS
Average- Men 124.4
Average- Women-111.8
General Average- 118.3
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• Daily Usage Diary

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1. To what extent is it convenient to adjust and
stick the Peerelief?
1-3 scale
1. Inconvenient 2. Moderately convenient 3.
Convenient
Peerelief No.
N8
44
45
2. Convenience while walking
1-3 scale
1. Inconvenient 2. Moderately convenient 3.
Convenient
Peerelief No.
N7
45
46
3. Convenience 2 hours after applying the
Peerelief
1-3 scale
1. Inconvenient 2. Moderately convenient 3.
Convenient
Peerelief No.
N7
46
47
4. Convenience after applying the Peerelief,
while sitting
1-3 scale
1. Inconvenient 2. Moderately convenient 3.
Convenient
Peerelief No.
N7
47
48
5. Convenience after applying the Peerelief,
while lying down
1-3 scale
1. Inconvenient 2. Moderately convenient 3.
Convenient
Peerelief No.
N6
48
49
6. Convenience after applying the Peerelief,
while walking
1-3 scale
1. Inconvenient 2. Moderately convenient 3.
Convenient
Peerelief No.
N7
49
50
7. How long after applying the Peerelief have you
removed it?
Average duration until removed- 5.7 hours
1-10 scale
Peerelief No.
N 5
One measurement is missing
50
51
8. On changing the Peerelif, was there any
leakage around the opening ( of affirmative
answers
YES
Percent of those who answered affirmatively
Peerelief No.
N5
51
52
9. Convenience of removing the Peerelief, in
order to change it
1-3 scale
1. Inconvenient 2. Moderately convenient 3.
Convenient
Peerelief No.
N6
52
53
10. While changing the Peerelief was the odor
eliminated, or not?
of responders who reported no odor
YES
Peerelief No.
N7
53
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11. While changing was there any rash,
sensitivity, swelling, burning, in the adhesive
area?
of responders who said no
NO
Peerelief No.
N 6
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11. While changing was there any rash,
sensitivity, swelling, burning, in the adhesive
area?
YES
of responders who reported burning
Peerelief No.
N6
of responders who reported swelling twice
55
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12. While changing was the skin dry or not?
1-3 scale
1. No 2. Moderately dry 3. yes
Peerelief No.
N7
56
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13. If you said that it was uncomfortable to
remove the Peerelief, for what reason?
58

• Characteristics
• Of the Sample

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Gender
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Age of men (N4)
Age of women (N4)
Average age of women 68
Average age of men 76
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Education
Income
Household size
Average years of education 11
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Religion
Ethnicity
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