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INDICATIONS FOR USE
The Renew® Insert is indicated for the management of Accidental Bowel Leakage (ABL) due to bowel
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:
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Bleeding hemorrhoids
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Rectal bleeding or bloody stool
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Anal/rectal pain, irritation, spasms, fissure or tearing
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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:
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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
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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 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.
*U.S. Clinical Study (Renew 210 CLD) published in Dis Colon Rectum 2015; 58: 892-898.
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.
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.
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