ANNEX:

PAT I E N T  G L O B A L  I M P R E S S I O N  I M P R O V E M E N T

Check the one number which best describes how your urinary tract condition is now, compared to how it was before you began taking medication in this study:

1. Very Much Better
2. Much Better
3. A Little Better
4. No Change
5. A Little Worse
6. Much Worse
7. Very Much Worse

 STUDY DESIGN

Placebo controlled clinical trial for pharmacological
treatment of SUI (duloxetine hydrochloride).3 
48 sites in the United States participated.
553 women aged 18-65 randomized.
Consisted of 2-week screening, 2-week placebo lead-in and 12-week treatment phase (see Figure 1).
PGI-I administered after single blind placebo lead-in and at each treatment-phase visit.
In order to assess patient's self perception of incontinence severity, Patient Global Impression Severity (PGI-S) was administered at the beginning of the study (self rating: normal, mild, moderate and severe).

CLINICAL CASE DEFINITION

CASE  DEFINITION

  Predominant symptom of SUI >3 months.

  No predominant symptoms of urge incontinence or enuresis.

  No prior continence surgery.

  Report:

  Incontinence episodes =4 per week.

  Diurnal frequency <8 per day.

  Nocturia <3 per night.

   Positive Stress Pad Test (SPT >2 gram).

   Positive Cough Stress Test.

 
MEASUREMENTS  USED  IN   VALIDATION

1.Incontinence Episode Frequency
   Obtained from real-time voiding and incontinence diaries.
   Most subjects completed for 7 consecutive days before each post-baseline visit.
   PGI-I was completed at each post-baseline visit (that is, just after the diary for
   that visit was completed).

2.Stress Pad Test (SPT)
   
Bladder volume was standardized to 400mL by normal
retrograde bladder filling.
   
Subjects performed specified activities:
    10 good coughs.
    10 deep knee bends.
    walking up and down the equivalent of 50 steps.
    Subjects were asked to try not to leak while performing the exercises.
    Difference in pre- and post-test weight was calculated.
    If SPT >2 grams, test was considered positive.  

3. I-QOL Questionnaire1,4

1- I worry about not being able to get to the toilet on time.

2- I worry about coughing or sneezing because of my incontinence.

3- I have to be careful standing up after I've been sitting down because
    of my incontinence.

4- I worry about where toilets are in new places.

5-  I feel depressed because of my incontinence.

6-  Because of my incontinence, I don't feel free to leave my home for
      long periods of time.

7-  I feel frustrated because my incontinence prevents me from doing what I want.

8-  I worry about others smelling urine on me.

9-  Incontinence is always on my mind.

10-  It's important for me to make frequent trips to the toilet.

11- Because of my incontinence, it's important to plan every detail in advance.

12- I worry about my incontinence getting worse as I grow older.

13- I have a hard time getting a good night of sleep because of my incontinence.

14- I worry about being embarrassed or humiliated because of my incontinence.

15- My incontinence makes me feel like I'm not a healthy person.

16- My incontinence makes me feel helpless.

17- I get less enjoyment out of life because of my incontinence.

18- I worry about wetting myself.

19- I feel like I have no control over my bladder.

20- I have to watch what or how much I drink because of my incontinence.

21- My incontinence limits my choice of clothing.

22- I worry about having sex because of my incontinence.

 

Responses to each question are:

1 = extremely, 2 = quite a bit, 3 = moderately, 4 = a little, 5 = not at all.

I-QOL Total Score = 100 x ([raw score lowest possible score] [highest possible score lowest possible score]).
= 100 x ([raw score 22] 88).

 

0: Worst Possible Quality of Life score.

100: Best Possible Quality of Life score.

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