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KegelMaster Clinical Study

Please note:  This report is part 
of a study that is pending formalization and submission 
to professional Research and Practice  journals.  

Until formal publication is completed, the researcher has requested that its name not be 
used at this time.  

We want to respect that request, nevertheless, we feel the information is still quite valuable.

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TO: Staff at KEGELMASTER

November 13, 2002

I agreed last summer to do an informal qualitative study on the use of KEGELMASTER's resistive exercise program on the effects of urinary incontinence in women. You sent me 25 units to use in the study which were distributed over a 6 week period. I have not yet written the complete study as there are still 9 women who have not reached the 90 day point in the study.

Results to date:

Units out: 23

Compliance rate (5x/week for 5-10 minutes) 17/23 (74%)

Reasons reported for noncompliance:

     Discomfort: 1 (Note this was the oldest participant , had had 7 children vaginally, a vaginal hysterectomy and a subsequent second AP Repair. She reported sacral muscle discomfort. It was theorized by me that she was incorrectly trying to close KEGELMASTER by pushing buttocks into bed. This was not the case and she was getting Kegel response. She quit using KEGELMASTER before the end of the first 30 day period. Theory is that with rearrangement of pelvic floor muscles, attachments were altered, and this sacral muscle discomfort was from anatomical adjustment.)

     Inconvenience: 5 (These people reported they were unable to block out a time for the daily regimen, although upon entering the study, had agreed to do so. Repeated follow-up calls to gain compliance in this area were unsuccessful.

30 Day Reported Results: (18 participants made the 30 day mark. 1 person is still in the initial 30 day period) 100% of reportedly compliant subjects stated they'd gone from constant urine leaking, occasional urine leaking , or stress incontinence at least 3 times/day down to once a day or less. Pad/diaper usage in these subjects declined from 3-5/day to 0-1/day. One subject (as previously noted) dropped the study due to discomfort during this timeframe, 3 dropped for stated reason of inconvenience.

60 Day Reported Results: Two more persons reported that they were no longer using KEGELMASTER as they "did not have time" and felt they no longer needed the exercise as their incontinence issues seemed to be resolved.(14 Participants passed the 60 day mark. 2 are still in that time period)

90 Day Reported Results: The 8 women who have passed the 90 day mark have reported no further bladder or bowel incontinence with 4-5x/week use of KEGELMASTER. Some of these women have opted to attempt a taper to find a maintenance level at which there are no "accidents". 6 women will be at the 90 day mark by the end of November. All 6 of those also report "no more urine or stool leaks".

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