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

1. Effectiveness of a jell absorbent pad in moderate to severe urinary incontinence Submitted to Tisteron LTd.

2. Contents Objectives & Methodology………………………………………………………3 Executive’s 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 2

3. 1 Objectives & Methodology

4. 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 usingcumbersome 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.

5. 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 committeeapproval at Rabin Medical Centre: • Study Type: Interventional • Treatment design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study • Estimated Enrollment: 90 patients. 5

6. 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. 6

7. 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.

8. 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. 8

9. 2 Executive’s Summary

10. 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.)

11. 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.

12. 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.

13. 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.

14. 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. 14

15. 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).

16. 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.

17. Main Findings

18. USIQ Results Before & After 3 18

19. 1. During the last week, in how many instances of urinating have you experienced urge ? Before After

20. 2. When you feel urge to urinate, is it: Before After

21. 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

25. Affect of Urinary Incontinence on Quality of Life 4 25

26. 7. To what extent do you feel, and if you feel, to what extent does it disturb you: Before After 26

27. 8. To what extent the urge to urinate affects: Before After

28. 13. On a scale from 0 to 100, if 0=death, and 100=perfect health, where would be your state of health? Before After

29. 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

30. 5 Antecedent Means Used to Cope with Incontinence

31. 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 ? Total average Expenditure: 247NIS Women’s average Expenditure: 247NIS Men’s Average expenditure 475 NIS

34. 6 Probability ofBuying & Adopting the Peerelief

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) (N=10) At the price of 7NIS per unit($2) N=11 At the price of 5NIS per unit($1.35) n=8 39

40. Appendices 7 40

41. Peerelief Urine Weight

42. Average weight of a used Peerelief (Grams) GRAMS General Average- 118.3 Average- Women-111.8 Average- Men – 124.4 42

43. Daily Usage Diary

44. 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. N=8 44

45. 2. Convenience while walking 1-3 scale 1. Inconvenient 2. Moderately convenient 3. Convenient Peerelief No. N=7 45

46. 3. Convenience 2 hours after applying the Peerelief 1-3 scale 1. Inconvenient 2. Moderately convenient 3. Convenient Peerelief No. N=7 46

47. 4. Convenience after applying the Peerelief, while sitting 1-3 scale 1. Inconvenient 2. Moderately convenient 3. Convenient Peerelief No. N=7 47

48. 5. Convenience after applying the Peerelief, while lying down 1-3 scale 1. Inconvenient 2. Moderately convenient 3. Convenient Peerelief No. N=6 48

49. 6. Convenienceafter applying the Peerelief, while walking 1-3 scale 1. Inconvenient 2. Moderately convenient 3. Convenient Peerelief No. N=7 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