LOSS OF BOWEL CONTROL? - Eclipse System
Transcript of LOSS OF BOWEL CONTROL? - Eclipse System
LOSS OF BOWEL CONTROL? BE YOURSELF AGAIN
– PATTY, AGE 39*
“My life was controlled by my bowels. I lived my life in fear of my next accident.”
You are not alone
1 in 5 women over 45 have experienced loss of bowel control.1
Symptoms associated with loss of bowel control can vary:
• Urgency: Sudden, strong urge to have a bowel movement
• Passive soiling: Leaking stool without knowing it
• Incomplete emptying: Remaining stool leaks out later
• Staining in undergarments• Constantly going to the bathroom
A weak pelvic fl oor aff ects the bladder, bowel, and vagina
Bladder
Uterus Bowel The pelvic muscles support the bladder, rectum,
and uterus. When these muscles are damaged, such
as with pregnancy or childbirth, it can lead to three
main pelvic fl oor issues: prolapse, loss of bladder
control, and loss of bowel control. Women are
also more likely to experience loss of bowel control if
they have a history of Irritable Bowel Syndrome3 or
other gastrointestinal conditions.
Why is this a women’s issue?
Loss of bowel control is treatable
Lifestyle
Diet modifi cation
Supplements/medications
Diapers / pads
Non-Surgical
Eclipse System
Pelvic fl oor physicaltherapy
Bulking agentinjections
Anal plugs
Surgical
Sphincter repair
Sacral NerveStimulation
Loss of bowel control is treatable Control is in your handsIntroducing the Eclipse System
DESIGNED FOR A WOMAN’S BODYVaginal insert that uses the body’snatural anatomy
NO SURGERY REQUIREDJust a simple offi ce visit to fi nd yourcorrect size
IMMEDIATE RESULTSWorks as soon as it’s in place
Comfortably fit to your body
In the LIFE clinical study, 86% of women who were successfully fit with an Eclipse reported that it was successful, after
completing a 1-month study. 96% of these women also reported Eclipse was comfortable, or that they couldn’t even feel it,
and 98% also reported that they would recommend Eclipse to a friend.2
reported that Eclipse was comfortable
96%
would recommendit to a friend
98%
reported treatment success with Eclipse
86%
Rests in the same place as a tamponGently occludes
the rectum
Tube connects to hand-held pump
Try Eclipse for a weekComfortably fit to your body
Before committing to the Eclipse System, you will have theopportunity to use a Trial Insert at home for a week or so. Use this trial period to decide if the Insert fits well and isright for you. Don’t forget, you can remove Eclipse yourselfanytime so you’ve got nothing to lose!
Indications for Use The Eclipse System is indicated for the treatment of fecal incontinence in adult women. It is intended for prescription use.
Contraindications The Eclipse System is contraindicated in the presence of a vaginal infection or open vaginal wound.
Warnings The Insert should be removed before obtaining an MRI to avoid adverse events. Women should consult a doctor before obtaining a pelvic X-ray since the Insert may obscure images. The Insert and the Pump are for single-patient use only. Sharing the devices could result in transmission of disease and/or infection. Women should remove the Insert immediately and notify their doctor if they experience any of the following: a foul odor or excessive vaginal discharge, difficulty urinating or defecating, significant bleeding not associated with menstruation, or any new onset or worsening pelvic pain or discomfort.
Risks In a clinical study of the Eclipse System, 117 women participated in the fitting process, and 61 women were successfully fit and entered a 1-month Treatment Period evaluation. Among the 61 women who entered the Treatment Period, there were no serious device-related adverse events. The most common adverse event was pelvic cramping and discomfort, and other observed events included pelvic pain, vaginal spotting and urinary incontinence. All adverse events were rated as mild or moderate, and lower rates of adverse events were observed after the initial Fitting Period was complete. All adverse events were resolved without surgery or significant intervention; most simply required removing the insert.
Please refer to the Eclipse System Instructions for Use (www.eclipsesystem.com/IFU) for a complete discussion of risks, contraindications, warnings, and precautions.
To learn more, please visit www.EclipseSystem.com
MKT394 Rev C | 0619 | ©2019 Pelvalon, Inc. All rights reserved.
2880 Lakeside Drive, Suite 201Santa Clara, Ca [email protected] Toll Free: 1-844-NO-TO-ABL (1-844-668-6225)
ECLIPSE SYSTEM IMPORTANT SAFETY INFORMATION
* While the quotation and age is of a real patient, the name is not. Data on file at Pelvalon.1 Brown HW, et al. Accidental Bowel Leakage in the Mature Woman’s Health Study. Int J Clin Pract. 2012;66(11):1101-8.2 Richter HE, Matthews CA, Muir T, et al. A Vaginal Bowel Control System for the Treatment of Fecal Incontinence (LIFE). Obstetrics & Gynecology. 2015;125(3):540-547.3Simren M, et al. Fecal Incontinence in Irritable Bowel Syndrome. Neurogastroenterol Motil. 2017 Feb; 29(2): 10.1111/nmo.12919