Indications For Use; Frequently Asked Questions - Renew Inserts REGULAR Mode D'emploi

ENG

INDICATIONS FOR USE

The Renew Insert is indicated for the management of Accidental Bowel Leakage (ABL) due to bowel
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incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage
of stool from the rectum.
DESCRIPTION
Renew Inserts are made of soft silicone and are safe and comfortable to use in the rectum. Renew Inserts
and the removable applicator are both single-use and non-sterile. Renew Inserts are available in 2 sizes:
Regular and Large.
Possible Side Effects May Include:
False urge to empty your bowels.
Mild irritation of anal area.
Warnings and Precautions
Bowel incontinence may be medically treated.
The Renew Insert is not intended to replace surgical options to treat ABL.
Consult your doctor for professional advice.
Do not use if you have an allergy to silicone.
Do not use with suppositories.
Discontinue using the Renew Inserts and consult your doctor if you experience the following:
Bleeding hemorrhoids
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• Rectal bleeding or bloody stool
Anal/rectal pain, irritation, spasms, fissure or tearing
•
Undergone rectal surgery within the past 4 weeks
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Displacement of the Insert upward into the anus and it is not expelled with the next bowel movement
•
Do not use if opened or damaged. Single use only. Non–sterile.
US CLINICAL TRIAL SUMMARY
A clinical study has shown that Renew Inserts are safe and work as indicated. Three sites enrolled 97 subjects
in this study. Safety data were analyzed on 91 treated subjects who used Renew Inserts. Reduction in the
frequency of Accidental Bowel Leakage (ABL) episodes was measured by comparing pre- and post-treatment
results on 85 subjects who used the Renew Insert for at least 1 week or more during the 12-week Treatment
Period. Reduction in the Wexner Score (an assessment of bowel incontinence) was analyzed on 77 subjects
who had both a pre- and post-treatment Wexner score.
Benefits
The clinical study demonstrated that the Renew Insert helps prevent Accidental Bowel Leakage,
delivering the following benefits:
A median reduction of 81.8% in the frequency of ABL episodes
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• Over 91% of the Renew Insert users demonstrated a ≥ 20% reduction in ABL episodes
A median reduction of 29.4% in the Wexner score
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Overall satisfaction among the majority of Insert users was high, with 91.4% rating the overall experience
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and ease of use as a 9.5 (median) on a 10 point scale
Risks
There were no reported severe, serious or unanticipated adverse events. Almost all (98.7%) of the adverse
events possibly related to the Renew Insert were rated as 'mild' and included the sensation of urge, irritation
or soreness around the anal area.
Displacement of the Insert may occur when the lower (bottom) disk of the Insert becomes temporarily
displaced and moves upward into the anus. Displacements of the Insert were reported by 23.9% of the study
participants. Instances of displacement of the Insert were resolved predominately by natural expulsion during
subsequent bowel movements.

FREQUENTLY ASKED QUESTIONS

1. Have Renew Inserts been clinically tested?
Yes. Clinical studies in the USA have demonstrated that the Renew Inserts are safe and reduce Accidental
Bowel Leakage by 81.8%*.
2. Are Renew Inserts comfortable to insert and wear?
Yes. Clinical studies show Renew Inserts are: soft, fit the contours of the body, comfortable to wear and easy
to use*. Inserting a Renew Insert properly will not cause discomfort. Just follow the step-by-step instructions.
If you still experience discomfort, discontinue use.
*U.S. Clinical Study (Renew 210 CLD) published in Dis Colon Rectum 2015; 58: 892-898.
3. How do I know when the Renew Insert is properly in place?
When the Renew Insert is properly in place, the top disk is resting just inside the rectum and the bottom disk
is just outside the anus. You should not feel any discomfort.
4. How long can I wear a Renew Insert?
Renew Inserts may be worn continuously, day and night. A single Renew Insert can be worn until your next
bowel movement, or changed as desired. After one is expelled, you may replace it with a new Insert. Never
use more than one Insert at a time.