“These Renew Inserts provide a new non-surgical option for managing Accidental Bowel Leakage, as an alternative or as an adjunct, to invasive therapy. The Inserts may restore patients’ dignity and provide them with the confidence to live a normal and active life.” – Carolynne Vaizey, consultant surgeon and Chair of Surgery at St Mark’s Hospital and Academic Institute

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.

Benefits

A 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
  • Over 91% of the Renew Insert users demonstrated a ≥ 20% reduction in ABL episodes
  • A median reduction of 29.4% in the Wexner score
  • 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
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
  • Rectal bleeding or bloody stool
  • Anal/rectal pain, irritation, spasms, fissure or tearing
  • Undergone rectal surgery within the past 4 weeks
  • 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.

Possible Side Effects
  • False urge to empty your bowels.
  • Mild irritation of anal area.
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.

Prescribing Information

Renew Inserts are listed in the Drug Tariff and are available on prescription from Chemists and Dispensing Appliance Contractors. Renew Inserts are available in 2 sizes: Regular and Large. Patients are advised to start with the Regular size Renew Insert. If the Regular size comes out at unexpected times or if your patient still experiences leakage, they should try the Large size Renew Insert. A convenient Starter Pack containing both sizes of Inserts is intended to help a patient determine their proper size when initiating use. If you have questions or experience difficulties prescribing Renew Inserts, please contact us for assistance on 0800 542 0814 or info@renew-medical.uk

*Renew clinical study CLD210 results, in press in the journal Diseases of the Colon & Rectum

Item Description Product Code Units per Pack PIP Code
Renew Inserts – Starter Pack 702 10 (5 Regular, 5 Large) 393-6911
Renew Inserts – Regular Size 706 30 393-6895
Renew Inserts – Large Size 707 30 393-6903
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