BB&T Contributing Editor

CHICAGO — As recently as 10 years ago, the treatments for urinary incontinence were polarized. They were either open, invasive surgery or conservative treatment such as pessaries, pads, biofeedback and kegel muscle exercises.

The surgery produced at best 80% effectiveness, while the conservative treatments only marginally improved patients' quality of life.

This past decade has evidenced a march to the middle of the spectrum that now includes treatments that are more effective and less invasive; including very minimally invasive surgeries, percutaneous neuromodulation, collagen remodeling and even Botox.

These "in the middle" treatments now fill the gap between surgery and behavior modification and were exhibited at the American Urogynecologic Society's (AUGS; Washington) annual meeting here in September.

The question is, since they are non-surgical will they be covered by insurance? It seems almost counter-intuitive that products designed to eliminate surgery would have to demonstrate safety, efficacy, and cost-effectiveness beyond the requirements of new surgical devices.

Urinary incontinence, which includes overactive bladder (OAB) and stress urinary incontinence (SUI), affects 33 million Americans, yet only 15 million seek treatment. It is thought that there are a multiplicity of reasons why only 50% of those afflicted ask for help but one of the main reasons (second to not knowing that there are a variety of options now available), is that many patients cannot afford the treatment unless their insurance pays for it.

Three companies with simple office-based procedures to treat urinary incontinence have yet to gain major traction in the market, influenced by adequate reimbursement (and in one case, FDA clearance) not yet being widely available.

Novasys Medical (Newark, California), Uroplasty (Minnetonka, Minnesota) and Allergan (Irvine, California) all have developed novel products that have been shown in studies to be effective treatments for incontinence but still face issues with Medicare coverage, the trigger for insurance companies to pay.

The FDA-cleared Renessa procedure by Novasys is an innovative non-surgical treatment for female stress urinary incontinence that has been available in physician offices since 2005. But until this past July, physicians had to use an unspecified CPT code for billing. As of July 1, the American Medical Association (AMA; Chicago) has issued a specific CPT code for the Renessa procedure. This new code will make it easier for payers to track utilization of the procedure.

The proprietary device uses low-temperature transurethral radio frequency to remodel collagen around the bladder neck and proximal urethra and results in firmer tissue with greater resistance to leaks. The treatment is performed in an office setting using local anesthesia and takes 30 minutes. More than 2,500 patients have been treated by some 350 doctors, but until insurance companies, both private and Medicare, establish coverage policies, reimbursement will continue to be inconsistent, leaving women with the option of trying another procedure that may be more invasive, or waiting until insurance companies cover it.

In the meantime, Novasys is marketing its product and training physicians how to best determine the ideal patient for the radio frequency remodeling treatment (see Table 1).

Another product that is in the midst of Phase II clinical trials for the treatment of overactive bladder is good ol' Botox, with presentations here that find it effective and cost-effective, but may find themselves in a similar predicament regarding payment.

Overactive bladder affects 16% of US adults and one-third of those are incontinent. But the drugs prescribed as first line of defense for this condition have discontinuation rates as high as 90% due to the side effects. Oftentimes, these patients are then offered Medtronic's (Minneapolis) Interstim sacral neuromodulation device that is implanted surgically and modulates the sensory nerve that is causing the overactive bladder by sending an electrical signal to the nerve.

In a poster presentation that evaluated Botulinum A Toxin (Botox) for the treatment of patients who were refractory to the sacral neuromodulation, Amir Shariati, MD, of Indiana University School of Medicine (Indianapolis), found that "Botulinum toxin detrusor injection is a reasonable treatment option for patients with detrusor overactive incontinence who have previously failed sacral neuromodulation, with effects lasting as long as six months."

And in a presentation from the podium, J.Wu, MD, of Duke University (Durham, North Carolina) shared the results from "A Cost-Effectiveness Analysis of Botulinum Toxin A Injection Versus Anticholinergic Medications for the Primary Treatment of Idiopathic Urge Incontinence." She said, "Over a two-year period, Botulinum toxin A injection was cost-effective compared to anticholinergic medications for the primary treatment of urge incontinence. Anticholinergics become cost-effective if patients are highly compliant with medications or if the botulinum procedure costs increase substantially."

With these studies setting the stage for non-invasive treatment for overactive bladder, reimbursement, once it is FDA-cleared, will remain the only barrier precluding patients from these office-based injections. But at about $4,400 per treatment, most patients will not be able to seek this non-surgical alternative until coverage is in place, which may take awhile.

A third company that has also developed an alternative to intolerable drugs or invasive surgery is Uroplasty, with its Urgent PC neuromodulation system. Almost a combination of acupuncture and the Interstim system, Uroplasty has developed a system that inserts a fine needle electrode near the tibial nerve and then applies electrical stimulation that travels through neural pathways to the sacral plexus.

Patients are treated in the office with an initial protocol of 12 weekly 30 minute sessions and maintenance therapy as needed.

Clinical trials have shown success rates of up to 80%, and although it is currently covered by several private insurers and by local Medicare carriers in many states on a case-by-case basis, Uroplasty is actively working with carriers across the country to ensure coverage for the millions of OAB patients who can benefit from this therapy.

Uroplasty, Novasys, and Allergan each have novel non-surgical alternatives to offer millions of patients with incontinence, but firmly established reimbursement will be the key to accessing those patients and claiming their full market potential.

Innovative kits evolving swiftly

It is not surprising that for a specialty recognized for its surgical expertise, innovative kits designed to further improve performance and shorten operating time continue to evolve at a rapid pace. That definitely was the case at the AUGS meeting, where second-generation surgical kits that supersede prior kits were launched.

Those new kits are enabling less-invasive surgery to become even less invasive in procedures for incontinence and prolapse that have traditionally been regarded as technically challenging.

Single-incision mini-slings and transvaginal prolapse repair kits are positioning pelvic procedures to be office-based procedures in the future. Granted, this might take five years or so to obtain long-term data and reimbursement for being performed in an office setting, but the technology demonstrated at this meeting has set the stage for this to occur; with the hope that by being performed in an office setting under minimal anesthesia, it will attract the hundreds of thousands of women who are currently forgoing these procedures.

It is estimated that 11% of American women will have surgery for pelvic organ prolapse (POP) sometime during their lifetime and that there will be 40 million women in the U.S. with POP by 2020. It also is predicted that 50% of all women who have children delivered vaginally will experience some form of prolapse later in life.

Given these numbers, it can be assumed that the more than 275,000 POP procedures performed annually in the U.S. are a mere tip of the iceberg. Until 2004, most surgeries for POP were technically challenging, had an unacceptable recurrence rate, and provided few devices to assist the surgeon.

Since then, Ethicon Women's Health and Urology (Somerville, New Jersey), American Medical Systems (AMS; Minnetonka, Minnesota), Caldera Medical (Agoura Hills, California), Boston Scientific (Natick, Massachusetts), Coloplast (Minneapolis), C.R. Bard (Murray Hill, New Jersey), MPATHY (Raynham, Massachusetts) and Endogun Medical Systems (Kibbutz Haogen, Israel) each have developed mesh and/or kits that assist the surgeon in performing POP procedures less invasively, in shorter time, and with drastically reduced recurrence rates.

In a presentation titled "One Year Anatomic and Functional Outcome after Reconstructive Surgery with Prolift Pelvic Floor Repair System," M. Alperin, MD, of the University of Pittsburgh analyzed pre- and post-op data on 40 women assessing objective and subjective outcomes after POP surgery using one such kit.

He said, "Anatomic support and functional outcomes at one year after surgery are promising with high patient satisfaction and an acceptable complication rate. Some 95% of the patients said that they would recommend the procedure to a friend."

Due to the high rate of failure with conventional vaginal prolapse repairs, many surgeons have turned to the use of transvaginal polypropylene mesh kits. However, as with any new procedure, trade-offs occur. It appears that the trade-off with using mesh in order to get a longer lasting — if not permanent — repair is that some patients experience pelvic pain and occasionally the mesh erodes the tissue surrounding it.

In order to reduce these side effects, second-generation mesh/kits were developed using either a lighter, softer mesh, smaller amounts of mesh, or totally transvaginal repair procedures involving less vulnerable tissue.

This shift to a totally transvaginal approach for POP parallels the development of "mini-slings" for stress urinary incontinence and sets up both procedures for an eventual shift into an office setting. There are many driving forces for making urogynecology procedures less invasive in addition to the improved effectiveness and quicker recovery for the patient.

Once these procedures are proven safe in an office setting, and once reimbursement is available to perform them in an office setting, it is felt that more patients will have these much-needed procedures performed. Since these conditions are not life-threatening, albeit quality of life-compromising, it is felt that the sheer inconvenience and fear of going into a hospital — along with the cost — has kept many patients untreated.

In addition, the time for travel to and from the hospital, along with OR turnover time, is unproductive and uncompensated time for the surgeon. The ability to perform these procedures in an office and get paid for them will be a win-win for both patient and surgeon and is expected to grow the market.

SUI treatments continue evolution

As with advances in prolapse procedures, traditional treatment for stress urinary incontinence, which affects 12 million Americans, has been with complicated surgeries.

Since the introduction of transvaginal tape (TVT) in 1996, these surgeries have been replaced by the use of kits that contain a sling, or mesh, that is placed under the urethra for support, and that utilizes one vaginal incision and two small abdominal incisions rendering it a much less invasive procedure and with equal or higher success rates of 85% to 95%.

Initially introduced by Ethicon Women's Health and Urology, American Medical Systems followed close behind in 2001 with its Transobturator Tape (TOT) sling and then was followed by several other manufacturers — including Caldera Medical, C.R. Bard, Boston Scientific, Coloplast, Endogun Medical Systems and Mpathy Medical, each with variations on the theme

Again, in an effort to make them even less invasive and a potential outpatient procedure, the mini-sling procedure was released in the U.S. in late 2006 by Ethicon Women's Health under the name TVT-Secure, followed by the March 2007 release of the AMS mini-sling, called the Mini-Arc.

Yitzach Asulin, MD, of the department of obstetrics and gynecology at Stamford Hospital (Stamford, Connecticut) reported in a poster presentation, "Short-Term Efficacy and Safety of the Miniarc: a Single Incision Sling vs. the Tension-Free Vaginal Tape Secur System in Women with Stress Incontinence," on a study in which eight patients were treated with the Secur mini-sling and eight with the Miniarc mini-sling.

He found that "both the TVT S and the Miniarc single-incision sling procedures appeared to be equally effective as surgical treatment of stress urinary incontinence in women. There appeared to be minimal complications, as these procedures were proven to be relatively safe with good short-term efficacy."

The next step in this evolutionary process would be to determine the feasibility of pain management in an office setting.

Michael Woods, MD, associate clinical professor at the University of Nebraska Medical Center (Omaha, Nebraska), assessed the feasibility of in-office placement of the Secur mini-sling under local anesthetic and reported his findings in a poster presentation titled "Vaginal Sling for Stress Urinary Incontinence Under Local Anesthetic in the Office Setting."

Woods said, "It appears that single-incision vaginal mini-slings are well-tolerated in the office setting with the use of local anesthetic only."

In another poster presentation, this one using the AMS mini-sling, M.J. Kennelly, MD, of McKay Urology (Charlotte, North Carolina), discussed "An Early Clinical Evaluation of the Miniarc Performed Under General or Local Anesthesia for the Treatment of Stress Urinary Incontinence."

He said, "Early data suggest the MiniArc can be performed under local anesthesia. Results of subjects under local anesthesia in comparison to those under general anesthesia showed shorter facility stay with minimal complications and little post-operative pain."

Given these early positive reports on less-invasive treatments for both pelvic organ prolapse and stress urinary incontinence, it was not surprising to see two new entries into this space.

One is Endogun Medical Systems, with its line of soft tissue fasteners for use with mesh for totally transvaginal POP and SUI procedures. Endogun leapfrogged directly into transvaginal procedural kits without evolving through the minimally invasive abdominal trocar insertion route first employed by established companies in urogynecology. FDA clearance was received this past April, followed by their product launch at this meeting.

This privately held company is seeking marketing partners for its line of products.

The other newcomer is MPATHY Medical, which launched its product line in the U.S. in May and exhibited for the first time at AUGS.

The company has developed a line of ultra-light mesh products specifically for urogynecology procedures that have been tested in more than 8,000 cases and claims to have near-zero erosion rates and complications.

Once data has been collected on these new procedures using transvaginal techniques over longer periods of time, and once efficacy and pain management can be demonstrated in an office setting, all that will be required is in-office reimbursement in order to drive this market and attract the hundreds of thousands of women who refuse to enter a hospital for a "female problem."

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