Will Rutan, CEO

Dr. Noar shared the latest Stretta data, along with his more than 10 years of Stretta clinical experience at a symposium, and performed both Stretta and Secca procedures for a live audience of conference attendees. Dr. Noar said, “There is certainly an increase in both fecal incontinence and GERD in India.  There is upward mobility in society, with a growing middle class, and increased disposable income. This leads to obesity, increased consumption of caffeine and alcohol and stress, all causes of uncontrolled reflux.  India, is also a multiparous society, and with multiple births per woman, the risk of fecal incontinence increases directly”. “The procedures were enthusiastically received by the Indian GI community, who felt that the demonstrations made the procedures look easy enough to encourage adoption into normal practice and that the long term data was compelling”, said Dr. Noar.

“Dr. Noar’s presentation of both Stretta and Secca to the participants was widely appreciated by all.” said Dr. Mahesh K. Goenka, Secretary of SGEI and Director of the Institute of Gastrosciences at Apollo Gleneagles Hospitals, Kolkata, India. “Since these were the first Stretta and Secca procedures in the country, it generated a lot of interest among the participants”, said Dr. Goenka.

Endocon 2012 was organized by the SGEI, along with the Kolkata Gastroenterologist Society, and the Indian Society of Gastroenterology West Bengal Chapter. The course was also endorsed by The American Society for Gastrointestinal Endoscopy (ASGE), and the European Society of Gastrointestinal Endoscopy (ESGE).

Sheila Doyle
Director of Marketing Communications

What does “Stretta” mean to you, especially if you have been around endoscopy for a while? Maybe nothing. Maybe you think of loading bags of sterile water into a refrigerator, or giving enough sedation to rival a complicated ERCP. But if you have memories, you recall a dwindling supply of disposable probes, then no probes at all. Eventually the Stretta generator was pushed into a corner of your unit, and finally, the equipment boneyard. Then one day an attending asks if you would find the Stretta because “it needs to be sent back”. So, what happened?

In the early 2000′s The Curon Corporation developed and introduced an endoscopically-guided, minimally invasive outpatient treatment for GERD that delivered radiofrequency energy to the LES and Gastric Cardia to improve the LES barrier function. Then in November of 2006, and through no fault of the equipment of technology per se, the company slid into bankruptcy. The treatment modality had become an orphan.

In November of 2008, Mederi Therapeutics purchased the intellectual assets of Stretta and, in September of 2011, relaunched the product with multiple upgrades that make it an honest 21st century therapy. Gone is the Rorschach-inspired user screen on the generator (did you see a rabbit?), replaced by a more user-friendly interface. The switch from analog to digital technology allows for a more stable, accurate, and reliable system with tighter control of the treatment parameters. The system settings are preset as defaults, the only variable for you to set is the cooling water flow rate. And the balloon inflation syringe now has a pressure release valve to prevent over inflation in the esophagus.

The treatment protocol is otherwise the same. Briefly, the inflatable balloon with 4 circumferential metal needles is deployed beginning at 1 cm above the Z Line with treatment at the 12 o’clock position, then a treatment after a 45 degree rotation. The process is then advanced into the cardia, the balloon is inflated to 25ml, and pulled back to tissue contact. The treatments are performed this time at the 12 o’clock position with repeats at 30 and 60 degrees rotation. The final cardia treatment is after pullback with 22ml of balloon inflation with the same rotation positions. All the while, the mucosa undergoes a cold saline irrigation to restrict heating to the smooth muscle while avoiding mucosal treatment. This procedure has previously been accomplished with (heavy) sedation, but with the increasing availability of anesthesia in the GI suite, and a roughly 45 minute procedure, expect to have another reason to call the anesthesia team.

As stated in the sales literature, the Stretta Procedure is “an effective solution to gastric reflux in well selected patients”. Such patients have a small hiatal hernia of less than 3 cm, have failed or do not want PPI therapy, or are not a candidate or do not want a more invasive procedure such as a fundoplication. Stretta is positioned as an intermediate treatment modality between medical and surgical management.

How does Stretta achieve its results? The application of concentrated RF energy causes a localized physiologic change in the smooth muscle, resulting in thickening and decrease of compliance, thus improving the reflux barrier of the LES. This application of heat does not produce “scarring” as some have thought. A smooth muscle relaxant will cause relaxation of a Stretta-treated area, scar tissue in this case would not relax. The smooth muscle undergoes a true physiologic change. Also, the ablation or demodulation of vagal afferent fibers in the treatment area reduces transient LES relaxations. And TLESR’s are a major mechanism with GERD.

The net result of the treatment, according to the meta analysis performed by Dr Scott Melving (of The OSU Hospitals) et al and presented at the 2011 DDW®, is significant reduction in esophageal acid exposure and Demeester scores. Plus a trend towards increased LES pressure that did not reach statistical significance.

Thanks for reading, and a special thank you to Will Rutan and Jeff Klindworth at Mederi for a helpful conversation.

Richard Barthelmes, RN, BSN, CGRN, Endoscopy Staff Nurse at The OSU Hospitals.

©OSGNA 2012

Although the prevalence of bowel control disorder and the extent of its impact on quality of life are drastically under-reported, there are several significant facts about it that are known.  Chief among them are that BCD can be a severely debilitating condition, and that it overwhelmingly targets women—particularly women who have had children.  What’s unknown is exactly how many women are affected.  The commonly accepted estimate in population-based studies is that one in 13 people suffers from BCD.  Considering the population as a whole this may be accurate, but looking specifically at the high-risk population for BCD—that is women, and in particular women who have given birth—the numbers may well be four times that of the overall population estimate.

Assuming this estimate is correct, or even close to correct, undiagnosed BCD is an epidemic of greater proportion than undiagnosed Type II diabetes, which is believed to exist in seven million Americans. And though BCD is not life threatening, like diabetes it can have a tremendous effect on quality of life. BCD, in fact, is a common side effect of poorly managed diabetes.

A major factor in the under-reporting of BCD is the silent suffering due to the embarrassment of those affected. Data demonstrate that only one in five younger female patients is willing to initiate a discussion related to incontinence with their primary caregiver. Sufferer silence thus gives way to primary caregivers’ lack of awareness of disorder prevalence, which then prevents patient referral to specialists with knowledge of the latest methods of treatment. This cycle most often ends unresolved, resulting in absurdly low numbers of sufferers getting the counselling and treatment they desperately need.

With regard to caregiver awareness, a common misconception among physicians is that bowel incontinence is a disease of “little old ladies”. Undoubtedly this is because elderly women tend to be the only women who seek treatment. Although it’s a fact that nearly 50 percent of nursing home residents have bowel incontinence, BCD is hardly a disorder of the elderly. A series of studies document that not only does BCD occur widely in women of childbearing age, but that by and large younger sufferers accept a poor quality of life rather than broach this subject with their doctor.

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“Incidence of Fecal Incontinence After Childbirth”, published in Obstetrics and Gynecology, February 2007 presented the following:  In this study group of women who delivered babies in Oregon in mid-to-late 2002, twenty-nine percent of the 8000+ respondents experienced bowel incontinence after childbirth. Nearly half of these women reported an incontinence event during intercourse.

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“Anal Incontinence after Vaginal Delivery: A Five-Year Prospective Cohort Study”, published in American Journal of Obstetrics and Gynecology, December 2004, studied first-time mothers with and without sphincter tears. It was determined that in both groups the incidence and symptoms of BCD at five months, nine months and five years post delivery was high, and worsened over time. Success rates in primary repair of sphincter injuries was frequently disappointing, with incontinence developing in approximately 40 percent of patients.

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“Anal Incontinence in Women Presenting for Gynecologic Care: Prevalence, Risk Factors and Impact upon Quality of Life”, published in American Journal of Obstetrics and Gynecology, November 2004 demonstrated that  BCD is prevalent among women presenting for routine GYN visits, that only 11 percent  of  sufferers had sought care for the problem and 83 percent had never been asked BCD questions by their physician.

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Given the stigma associated with BCD, it cannot be left to patients to initiate a discussion of the disorder. In every primary care visit by women of childbearing age or older, physicians need to ask the question, “In the last year have you experienced symptoms of bowel control disorder?”  This should be followed by the statement, “It’s much more common than you may think”.

The estimate, in fact, is that some degree of the disorder is experienced by as many as one in three women—or up to 20 million American women younger than 55. Among this number, based on current US divorce statistics, are some 10 million women who may be seeking new mates, but who are in the embarrassing situation of being victims of BCD.

To ensure proper treatment, physicians need to stay current on all treatment options.  As well, hospitals need to market new treatments to alter the perception of most BCD sufferers that no viable solution to their problem exists.

For the few patients who have actively sought help for their disorder, depending on the severity of their symptoms the treatment pathway usually has begun conservatively.  Initial treatment has included dietary changes, constipating drugs, exercises and biofeedback. If these measures failed, with no other option, the next step has been a significant leap to invasive surgery, such as sphincter repair, an artificial sphincter or a colostomy—expensive, marginally effective and/or disfiguring.  Many patients appear not to have chosen that option.

Assuming the estimate of 20 million young, female BCD sufferers is accurate, the following study validates the enormous gap between the number of sufferers, and the number of surgical treatments for the condition.

The Study, “National Trends and Costs of Surgical Treatment for Female Fecal Incontinence”, presented at The Society of GYN Surgeons in April, 2007, showed that during the five-year study period (1998 to 2003) the number of annual surgical procedures for BCD remained flat at approximately 3,500, while costs continued to escalate.

In summary, bowel control disorder will never be proper dinner-table conversation, or perhaps ever be an appropriate topic for television commercials, but it needs to come out of the bathroom and into the offices of primary care physicians. Only then, when the disorder is routinely discussed with female patients of childbearing age or older, can the stigma lessen and the epidemic proportions of this now-little-known disorder be diminished.

Author: William Rutan is the CEO and President of Mederi Therapeutics Inc. of Greenwich, CT, makers of the Secca Therapy System for minimally invasive treatment of BCD.

Published online January 2010, www.massdevice.com
http://www.massdevice.com/whitepapers/epidemic-incidence-little-known-disorder”>http://www.massdevice.com/whitepapers/epidemic-incidence-little-known-disorder

REFERENCES:
Incidence of Fecal Incontinence After Childbirth. Jeanne-Marie Guise, MD, MPH, Cynthia Morris, PhD, MPH, Patricia Osterweil, Hong Li, MD, MSPH, Deborah Rosenberg, and Merwyn Greenlick, PhD. Obstetrics and Gynecology, February 2007.

Anal Incontinence After Vaginal Delivery: A Five-year Prospective Cohort Study. John Pollack, MD, Johan Nordenstam, MD, Sophia Brismar, MD, Annika Lopez, MD, PhD, Daniel Altman, MD, and Jan Zetterstrom, MD, PhD. American Journal of Obstetrics and Gynecology, December 2004.

Anal Incontinence in women presenting for gynecologic care: Prevalence, risk factors, and impact upon QOL. Muriel K. Boreham, MD, Holly E. Richter, PhD, MD, Kimberly S. Kenton, MD, Charles W. Nager, MD, W. Thomas Gregory, MD, Michael P. Aronson, MD, Val Y. Vogt, MD, Don D. McIntire, PhD, Joseph I. Schaffer, MD. American Journal of Obstetrics and Gynecology, November 2004.

National trends and costs of surgical treatment for female fecal incontinence. Vivian W. Sung, MD, MPH; Michelle L. Rogers, PhD; Deborah L. Myers, MD; Homayoon M Akbari, MD, PhD; Melissa A. Clark, PhD. American Journal of Obstetrics and Gynecology, December 2007.

• Mean heartburn score decreased from 5.31 to 1.79 (P <0.01)
• Mean regurgitation score decreased from 5.02 to 1.64 (P <0.01)
• Mean cough score decreased from 6.77 to 2.85 (P <0.01)
• Mean wheezing score decreased from 7.83 to 3.07 (P <0.01)
• Mean hoarseness score decreased from 5.13 to 1.81 (P <0.01)

In their conclusion, the authors state that the data suggests a beneficial effect in control of GERD-induced RSs and that endoscopic RF is a safe and effective means of treating these patients. They suggest further studies are needed to evaluate the mechanism of the effects on RSs, and to gather placebo-controlled data with long-term follow-up.

Link to PubMed abstract: http://www.ncbi.nlm.nih.gov/pubmed/21542958
Link to original article in Chinese Medical Journal:
http://www.cmj.org/Periodical/paperlist.asp?id=LW201141380457109677&linkintype=pubmed

Contributors:
Sheila Doyle, Manager, Communications and Marketing, Mederi
Mario Nacinovich, Managing Director, AXON

Mederi will be showcasing both Secca Therapy for BCD and Stretta Therapy for GERD at next week’s combo Symposium – Booth 10. The Symposium agenda includes sessions on Options for the Management of Fecal Incontinence, a presentation on patient selection for Secca Therapy, by Professor Roman Herman from University of Krakow, Poland, and a talk on the Costs of Anal Incontinence, by Dr. Marvin Corman from Stonybrook University in New York.

We hope to see you there!

Sheila Doyle
Mederi, Marketing

Professor Wexner said, “There is a significant unmet need for the minimally invasive treatment of mild to moderate faecal incontinence. Radiofrequency therapy may provide a safe, effective alternative”.

The Secca workshop was sponsored by the Ficocentre. Ficocentre is the UK provider of Secca Therapy, with five centres operating within the UK to connect patients with fecal incontinence to this minimally invasive treatment. Further Secca workshops in the UK will be arranged during the year. For more information go to www.ficocentre.com, or follow @ficocentre on Twitter.

Great work Ficocentre and special thanks to all who participated!

Sheila Doyle
Mederi, Marketing

Follow Mederi on Twitter @MederiNews. Keep up to date with the latest information on Secca Therapy and Stretta Therapy and the disease states they treat. If you’re interested in the conditions GERD and Bowel Control Disorder, their prevalence and treatment options, follow Mederi.

Add to the conversation and search for information using these hashtags:
#seccatherapy
#strettatherapy
#GERD
#BCD

Thanks for continuing the conversation with us.

Sheila Doyle
Mederi, Marketing

CONTRAINDICATIONS: There are no known absolute contraindications to the use of radiofrequency in humans. The use of the Stretta System is contraindicated when, in the judgment of the physician, radiofrequency surgical procedures would be contrary to the best interests of the patient. The following is a list of patient groups in whom the use of the Stretta System for the treatment of GERD may be contraindicated: Subjects under the age of 18; Pregnant women; Patients without a diagnosis of GERD; Hiatal hernia > 2 cm; Achalasia or incomplete LES relaxation in response to swallow; Poor surgical candidate.

The following is a list of patient groups who have not been specifically studied using the Stretta System for the treatment of GERD. The performance characteristics of the device for the following groups of patients have not been established: Normal 24-hour pH study; ALL GERD symptoms completely unresponsive to properly dose-escalated anti-secretory medication; Barrett’s metaplasia; Poor surgical candidate; Presence of dysphagia, esophageal bleeding, or gas bloat; Active esophagitis grades III or IV by Savary criteria; Endocarditis risk (mitral valve prolapse, heart valve replacement, etc.); Untreated or unstable hypertension, diabetes mellitus, heart disease, collagen vascular disease, steroid use, immunosuppressed state, or cardiac pacemaker; Abnormal blood coagulation or use of anticoagulant or platelet anti-aggregation therapy.

WARNINGS: These complications are rarely seen but could potentially occur with the use of electrosurgery for the treatment of GERD (alphabetical order): Bleeding – transient; Bloating; Chest pain – transient; Difficulty belching – transient; Dysphagia – transient; Epigastric discomfort – transient; Esophageal mucosal laceration; Fever – transient; Injury to esophageal mucosa; Perforation; Pharyngitis; Vomiting – transient with potential for bleeding or Esophageal injury. If any vomiting occurs, contact your treating physician immediately. Excessive vomiting may result in perforation and more serious injury resulting in death.

The following complications have not been seen, but could possibly occur infrequently (alphabetical order): Achalasia; Delayed gastric emptying – transient; Dental injury; Dyspnea; Infection; Larynx injury; Worsened GERD.

CONTRAINDICATIONS: There are no known absolute contraindications to the use of radiofrequency in humans. The use of electrosurgery is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interest of the patient. The following may be considered contraindications specific to this procedure: Crohn’s disease or ulcerative colitis (inflammatory bowel disease); Collagen vascular disease (Raynaud’s, Systemic Sclerosis); History of anal abscess, fistula or prolapse; Constipation or chronic diarrhea as sole cause or the major contributor in bowel incontinence; Abnormal blood coagulation or use of anticoagulant or platelet anti-aggregation therapy (other than aspirin); Subject has undergone pelvic irradiation; Subject is pregnant; Subject has current or history of laxative abuse; Poor surgical candidate, or reduced life expectancy that limits follow-up; Subject suffers from unstable psychiatric disorder(s); Subject is less than 18 years of age; Subject has any type of anorectal foreign body implant, such as a bulking agent.

WARNINGS: Use of electrosurgery for the treatment of fecal incontinence may result in the following complications: Bleeding from the anal canal with the possible need for surgery (to correct bleeding), and/or transfusion; Burn related to position of return electrode; Diarrhea related to antibiotic prophylaxis; Difficulty having a bowel movement, constipation; Fever; Hypoxia and other injury related to conscious sedation; Infection with possibility for surgery and/or antibiotics to correct infection; Injury to the anorectal lining with possible stricture formation; Nausea; Over-tightening or stricture formation (making the anal sphincter too tight; Pain during the procedure or transiently after the procedure; Pain or difficulty with bowel movements; Pain or difficulty with urination; Perforation with possibility for surgery and/or antibiotics to correct perforation; Pudendal nerve injury; Rectovaginal fistula with possibility for surgery and/or antibiotics to correct fistula; Submucosal hematoma, minor; Surgery, colostomy, and/or antibiotics to correct injury or infection related to procedure; Transient worsening of fecal incontinence symptoms.