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Single Incision Mini-Sling
Single Incision Mini-Sling: The next step in Minimally Invasive Treatment For Stress Urinary Incontinence
The Mini-Sling – The newest least invasive sling for Stress Urinary Incontinence
Dr’s Moore and Miklos are very excited to be one of the first centers in the US to offer the next step in minimally invasive treatment for SUI…..the single incision Mini-sling. The procedure utilizes the same concepts of the tension-free tape mid-urethral slings, however only one incision is needed and the procedure can be completed in as little as 5-10 minutes under local anesthesia!! The procedure was initially released in September of 2006 by Gynecare with a procedure called the TVT-Secure and Dr Miklos and Moore were some of the first surgeons to evaluate and study the procedure. They liked the concept of a single incision sling, however were not enthused by the engineering and design of the Secure sling. In early 2007, with development input from Dr Moore and Miklos, American Medical Systems made several improvements to the procedure and in April, Dr Moore was the first surgeon in the United States to place the Mini-Arc mini-sling (click here to view press release). Dr Moore’s and Miklos’ center in Atlanta, because of their reputation of being world leader’s in treatment for SUI, was chosen as the lead center in the USA to evaluate and study the Mini-Arc procedure. Dr Moore was chosen as principal investigator, leading 5 centers in the USA and the world, to study and present the initial results in the USA, which have been excellent and very exciting! Since 2007, the results have continued to be impressive and it has become a mainstay in treatment in female SUI. Once again, Dr Moore and Miklos were in the lead of bringing new technology to the field of female urology that has now become a procedure that has been adopted world-wide.
Dr Moore, along with Dr Miklos, in 2009, were the first in the world to publish longer term follow-up on patients that underwent the Mini-arc sling in the Journal of Surgical Technology (click here to view paper). They found a cure rate of over 90% at one year, which is consistent with other slings such as the TVT and the TOT sling and minimal risks of any complications. Dr Moore is also co-author of the largest multi-center trial completed to date in the world on the mini-arc mini sling which was just published in the Journal of Urology in August of 2010. Consistent with their first paper, the multicenter trial (centers from all over the world were involved in this trial, along with Dr Moore and Miklos’ Center) showed an objective cure rate of over 90% with very low risk of voiding dysfunction (ie obstruction), pain, infection or other complications. Average hospital stay was less than 3 hours and return to normal activity was very rapid. Dr Ty Erikson presented a study at the American College of Ob/Gyn that showed that almost 70% of women did not take ANY pain medication after having the procedure completed... another indication of how minimally invasive the procedure is.
Mini Sling Background
As stated by the American Urologic Association consensus statement in 2001, there are only 2 procedures that are proven to have effective long-term cure rates for the treatment of stress urinary incontinence (SUI). These procedures are the abdominal Burch Colposuspension (or MMK) and the sling procedure that is completed vaginally. However, in the past, the sling procedure was far from standardized. There have been multiple different descriptions using different materials for the sling (fascia from the patient, cadaveric fascia or dermis from humans or animals, synthetics, etc), different anchoring points, and different methods to adjust the tension of the sling. In many cases patients had to undergo general anesthesia, were in the hospital for several days, required a catheter to drain the bladder coming out of the abdomen (because it took so long to void on their own) and many patients suffered high rates of voiding dysfunction following these slings.
However the introduction of the tension-free vaginal tape procedures to the United States in the late 90’s revolutionized the treatment of SUI. It introduced a standardized sling procedure that could be completed safely in 20 minutes under local anesthesia, utilizing 3 very small incisions with minimal dissection, a cough test for individual tension patient adjustment and excellent cure rates. Over 1 million of these procedures have been completed worldwide. This procedure was called the TVT sling and since several other types of similar slings have been developed to try to improve on its safety.
Single Incision Mini- Sling- New, Safer Approach
Despite its relative safety, the original tension free vaginal tape procedures require the blind passage of needles through 2 small incisions in the abdomen just above the pubic bone. The retropubic space that the needle has to pass through to get to these abdominal incisions is also a very vascular space with venous plexuses and the potential for injury to large blood vessels in the pelvis. Secondary to this and the areas that the needle has to pass to place the mesh tape, there is potential for complications such as injury to the bladder, intestines, or nerves in the pelvis and/or abdomen. All of these injuries have been reported in the literature. Secondary to this, physicians in Europe began investigating to find a safer approach to place the mesh tape sling.
Risks of Retropubic Needle Passage
- Bladder Injury
- Bowel Injury
- Major Vascular Injury
- Nerve Injury
Passage of Retropubic Needles for TVT, SPARC, etc.
The needle on the left shows a safe passage,
the needle on the right shows potential injury
to abdominal wall vessels or pelvic vessels or nerve.
The Transobturator Sling- The first step towards less invasive
The transobturator sling was developed to help reduce the risks of retropubic needle passage. In the Netherlands in 1998, Nickel et al reported a successful sling procedure using a polyester ribbon passed through the obturator foramen and around the urethra for treatment of refractory urethral sphincter incompetence in female dogs. In France in 2001, Delorme introduced the transobturator sling procedure in humans. Dr. Moore and Miklos were two of the first surgeon’s in the United States to utilize this newer, safer approach to the tension free tape sling procedure. Instead of passing needles blindly through the abdomen, the TOT procedure involves passing needles through the groin to place the sling, which is a safer approach. They both traveled to France to operate and train with the experts and world leaders to bring this technology to the US. Since its introduction in the US in 2003, multiple studies has shown it to be a very safe procedure with less risks than the TVT and with similar cure rates. Dr Moore was the principal investigator of a worldwide study on the Monarc transobturator approach leading centers from France, Italy, Germany, and throughout the US including Harvard and the Cleveland Clinic. He presented the results of the study in France, Greece, Argentina and the US at major international meetings showing the procedure to be very safe and effective.
TOT sling utilizes needles passed through the groins for placement
of the mesh tape at the mid-urethra in a tension-free manner.
Despite its improved safety profile and excellent cure rates, the procedure still involves passing needles through the groin, which in certain patients can result in groin pain. Although the risk is very low, especially with the outside-in approach like the Monarc TOT sling, the risk still exists. Secondary to this, a new procedure involving only one incision vaginal, and NO incisions in the abdomen or groins and NO needle passages through the abdomen or groins has been developed.
Advantages of the Single Incision Mini-Sling
- Safer, faster, more efficient, less pain
- Decreased risk of:
- Bowel Injury
- Bladder Injury
- Major Bleeding
- No Retropubic Needle Passage
- No Groin needle passage
- No Abdominal or Groin Incisions
- Same Anatomic Position of Tape
Only one small incision is needed in the vagina. No incisions are needed in the groins or the abdomen and no needles are needed to pass through the abdomen or groins. This decreases the risk of injury, however the sling still is able to go in the same position, ie mid-urethra in a tension-free manner. Since there is no need for needle passage through the groins or abdomen, the procedure can very easily be done under local anesthesia, in an outpatient type setting or even in an office procedure room setting in as little as 10 minutes! Many patients state that they didn’t even use any pain medication after having the procedure completed!!
The mini-sling requires only one small vaginal incision and NO incisions or needle passage through the groins or abdomen!!
The dotted arrows show the final position of the mini-sling placement. The blue circles in the groin are where needles are passed with the TOT approach. However, with the Mini-sling, no groin incisions are necessary as the sling is placed with just one small vaginal incision in the same position of the TOT.
Principals of the Mini-Sling Approach
The mini-sling is placed in the same incision and the same position as the TOT sling (for anatomy of TOT sling- Click Here). A small incision is placed under the urethra (Fig 4a,b below) and the tape is placed in a hammock type shape (Fig 5) under the urethra under local anesthesia and a small amount of sedation. This position has been shown to have the same cure rates of the TVT sling, however it is a less acute angle that mimics the natural position of the pubo-urethral ligament and therefore there is less risk of urinary obstruction ( which requires long-term catheter use) and also less risk of bladder injury or injury to major vessels as it is a safer approach than passing needles back behind the pubic bone and up through the abdomen.
The procedure is completed through a single, very small incision in the vagina under the urethra and the sling placed through a very small tunnel created by scissors.
The needle and sling is passed through a small vaginal incision and penetrates the sidewall muscle (obturator). The self-fixating tip keeps the sling in place while tissue in-growth occurs.
The sling is placed through one small vaginal incision and passed into the pelvic sidewall muscle (the obturator and levator fascia and muscle). The Mini-Arc sling has a self-fixating tip on it that holds the sling in place once it penetrates the muscle. No needles are needed to pass through the groins, which decreases the risk of post-op groin pain. The self-fixating tips allow the sling to stay in position and not move (it has been tested to withstand 5x the force of a typical pelvic floor event like a cough, sneeze, etc) while the body heals and grows into the mesh material, which further fixates the position of the tape. The sling is placed under the mid-urethra in a tension-free position so as to not obstruct voiding.
The mesh used for the mini-sling is the same mesh that we have been using for 10 years now in sub-urethral slings, ie the same mesh used in the original TVT slings, which has become the most studied procedure EVER for female SUI. This means we are comfortable with the material and know how it reacts within the human body. We know that this mesh is the best tolerated material to date with the least amount of complications. Issues such as infection or rejection of this type of material are very, very rare. Tissue ingrowth occurs rapidly and it basically becomes a new ligament that prevents urinary leakage in women in 90% of cases!!
Mini-sling Mimics Normal Anatomy
The transobturator mini-sling forms a subfascial hammock of support under the urethra. This mimics the normal position of the pubourethral ligament. This is the ligament that typically provides the backboard of support to help prevent urinary leakage with stress events such as coughing, laughing, sneezing, exercising, etc. When this ligament is damaged or stretched out secondary to childbirth, aging, chronic straining, etc, stress urinary leakage may ensue. The position of the mini-sling reproduces the natural position of this ligament and in a sense replaces the damaged ligament with a permanent mesh tape that provides the support needed to prevent leakage ( figure 6 below). The angle of the mini-sling is much less acute than the traditional pubovaginal sling procedures such as the TVT or SPARC, therefore not only is this more anatomic and natural, it also makes sense that there is less problems with urinary dysfunction such as urinary obstruction (not being able to void).
Position of Mini-sling duplicates position of pubourethral ligaments.
This is a natural angle of the ligament and when the sling is placed in same
position it is felt to reduce post op voiding dysfunction.
Clinical Results and Complications
The mini-sling procedure was initially released in the United States over a year ago by Gynecare/Johnson and Johnson under the name of TVT-Secure. The initial results of this method were presented earlier this year (2007) at the International Urogynecology Meeting and were not as promising as hoped. The short term cure rates of the TVT-Secure were reported in the range of 67-83%, clearly much lower than procedures such as the TVT sling or the TOT sling. It is felt this is due to engineering deficits of the Secure kit, not in the concept of the procedure of the mini-sling itself. The Secure has bladed trocars attached to the mesh that are very difficult to release once the mesh penetrates the muscle and because of this the sling may loosen when trying to release the trocars. Additionally, the Secure does not offer self-fixating tips therefore the sling may move and loosen in the immediate post-operative period before tissue in-growth occurs leading to lower cure rates. In March of 2007, AMS released the most recent mini-sling to the market called the Mini-Arc which has several improvements over the Secure sling including much smaller and safer needles that are much easier to use for placement of the mesh tape and also self-fixating tips on the mesh that keeps the mesh in-place immediately upon placement and secures it until tissue in-growth occurs.
The initial results of the first multicenter retrospective study of Mini-Arc in the world was presented at the IUGA meeting this year by Dr Moore in a symposium on SUI and were very promising. The average time of the procedure was 7 minutes and blood loss was less than 25cc per case. The short-term cure rate was reported to be 92.3%, which is consistent with other proven slings such as the TVT and TOT slings. There were no complications noted and no patients reported any pain at the site of the sling at follow-up. Five centers in the US were involved in the trial, with Dr Moore and Miklos’ center in Atlanta being the lead center.
Click here for complete details of the initial Mini-Arc study.
As reviewed earlier, follow-up studies with longer term data have also been very promising, most showing cure rates over 90%. Secondary to being one of the first centers in the world to help develop, study and utilize the mini-sling approach, Dr Moore and Miklos were the first in the US and the world to publish longer term data (click here for Journal of Surgical Tech paper) and were also involved in the largest multicenter trial in the world to investigate the Mini-arc mini sling and the results just recently published in the Journal of Urology (click here to view paper).
Risks and complications are rare, however include the same risks associated with any tension-free mesh sling including bleeding, infection, voiding dysfunction, urinary retention, mesh erosion (in the vagina or urethra), pain in the vagina or groins. The risk of bowel or bladder injury as well as the risk of major bleeding are significantly reduced compared to retropubic approaches.
Atlanta Urogynecology Experience
Dr. Moore and Miklos were two of the first surgeons to bring this new technology to the United States. They are leaders in the Southeast and the US as well as the world in both performing and teaching the procedure. Both surgeons were involved in the initial development of the procedure as well. Dr Moore has traveled throughout the country and has taught surgeons in New York, Miami, Los Angeles, San Francisco, Chicago, Dallas, Houston, Denver, Seattle, Alabama, Michigan, and of course, Atlanta. He has led symposiums, lectured on the topic and presented research studies to world leaders at the International Urogyn Assoc Annual Meetings in Mexico, Taiwan and last summer in Italy. He and Dr Miklos have travelled, operated and taught surgeons the procedure in Mexico, Taiwan, Russia, Poland, Finland, Italy, Chile, Argentina, Brazil, Australia and most recently Dr Moore was taught and performed the first Mini-arc slings in Calli, Medellin and Bogota, Colombia, SA. Surgeons from all over the country also travel to Atlanta to learn the new technique from Dr Miklos and Moore.
The Mini-sling procedure takes as little as 5-7 minutes to perform and can be completed under local anesthesia with minimal risks with very little down time or loss of work!
To date Dr Miklos and Moore have seen the same excellent clinical success seen in the multicenter US trial. No patients have complained of postoperative pain in the area of the sling, and there has been mimimal risk of sling erosion or exposure. No patients have had any significant bleeding or other major complications. The procedure takes less than 10 minutes to perform and can be completed under local or regional anesthesia. They also have found this approach useful in obese patients and women with retropubic scarring, in whom retropubic needle passage can be a challenge. They also believe that by keeping the sling sub-fascial and away from the bladder and the retropubic space, that they also may be reducing the risk of creating bladder irritability that may occur with slings that are in contact with the bladder wall. Patients have very little post-op pain and many have returned to work the following day after the procedure.
As with any surgical procedure, Dr Moore and Miklos will evaluate the patient’s condition and deem what surgical procedure is most appropriate for that particular patient. The TVT retropubic sling as well as the TOT sling still have a role in treatment of SUI in certain patients and they will discuss these options clinically indicated.
Dr Moore's and Dr. Miklos's published papers and studies regarding the Mini-sling may be found below:
- 12 Month MiniSling Study
- Mini-sling – New Minimally Invasive One-incision Sling for Treatment of Female Stress Urinary Incontinence
- MiniArc Single-Incision Sling System
- MiniSling Touch Briefings
- Prospective Evaluation of a Single Incision Sling for Stress Urinary Incontinence - Journal of Urology August 2010
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