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Laparoscopic Burch Colposuspension 377
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45. Flax S. The gasless laparoscopic Burch bladder neck suspension: early experience. JUrol. 1996;156(3):1105–1107.
46. Lobel R, Davis G. Long-term results of laparoscopic Burch ure­thropexy. J Am Assoc Gynecol Laparosc. 1997;4:341–345.
47. Speights SE, Moore RD, Miklos JR. Frequency of lower urinary tract injury at laparoscopic Burch and paravaginal repair. JAm Assoc Gynecol Laparosc. 2000;7(4):515–518.
48. Harris R, Cundiff GW, Theofrastous JP, Yoon H, Bump RC, Addison WA. The value of intraoperative cystoscopy in urogy­necologic and reconstructive pelvic surgery. Am J Obstet Gynecol. 1997;177:1367–1371.
49. Soulie M, Salomon L, Seguin P, et al. Multi-institutional study of complications in 1085 laparoscopic urologic procedures. Urology. 2001;58(6):899–903.
50. Aslan P, Woo H. Ureteric injury following laparoscopic colposus­pension. Br J Obstet Gynaecol. 1997;104:266–268.
51. Dietz HP, Wilson PD, Samalia KP, Walton J, Fentiman G. Uretericinjuryfollowinglaparoscopic colposuspension.BrJObstet Gynaecol. 1997;104(10):1217.
52. Dwyer PL, Carey MP, Rosamilia A. Suture injury to the urinary tract in urethral suspensionprocedures for stress incontinence.Int Urogynecol J Pelvic Floor Dysfunct. 1999;10(1):15–21.
53. Lawton V, Smith AR. Laparoscopic colposuspension. Semin Laparosc Surg. 1999;6(2):90–99.
54. Fatthy H, El Hao M, Samaha I, Abdallah K. Modified Burch colposuspension: laparoscopy versus laparotomy. J Am Assoc Gynecol Laparosc. 2001;8(1):99–106.
55. Lavin JM, Foote AJ, Hosker GI, Smith AR. Laparoscopic Burch colposuspension: a minimum of 2 year’sfollowupandcomparison with open colposuspension. Gynaecol Endosc. 1998;7:251–258.
56. Bergman A, BallardCA, Koonings PP. Comparison of three differ­ent surgical procedures for genuine stress incontinence: prospec­tive randomized study. Obstet Gynecol. 1989;160:1102–1106.
57. Wang AC. Burch colposuspension vs. Stamey bladder neck sus­pension. A comparison of complications with special emphasis on detrusor instability and voiding dysfunction. JReprodMed. 1996;41(7):529–533.
58. Jarvis GJ. Surgery for genuine stress incontinence. Br J Obstet Gynaecol. 1994;101(5):371–374.
59. Su T, Wang KG, Hsu CY, Wei HJ, Hong BK. 1997. Pospective comparison of laparoscopic and traditional colposuspensions in the treatment of genuine stress incontinence. Acta Obstet Gynecol Scand. 1997;76:576–582.
60. Polascik TJ, Moore RG, Rosenberg MT, Kavoussi LR. Comparison of laparoscopic and open retropubic urethropexy for treatment of stress urinary incontinence. Urology. 1995;45(4):647–652.
61. Kohli N, Jacobs PA, Sze EH, Roat TW, Karram MM. Open com­pared with laparoscopicapproachtoBurch colposuspension:a cost analysis. Obstet Gynecol. 1997;90(3):411–415.
62. Hashizume M, Sugimachi K. Needle and trocar injury during laparoscopic surgery in Japan. Surg Endosc. 1997;11:1198–1201.
63. Hurd W, Pearl ML, DeLancey JO, Quint EH, Garnett B, Bude RO. Laparoscopic injury of abdominal wall blood vessels: a report of three cases. Obstet Gynecol. 1993;82S:673–676.
64. Boike G, MillerCF, Spirtos NM. Incisional bowel herniations after operative laparoscopy: a series of nineteen cases and review of the literature. Am J Obstet Gynecol. 1995;172:1726.
65. Margossian H, Pollard RR, Walters MD. Small bowel obstruction in a peritoneal defect after laparoscopic Burch procedure. JAm Assoc Gynecol Laparosc. 1999;6(3):343–345.
66. Cheon W, Mak JH, LiuJY.Prospective randomisedcontrolledtrial comparing laparoscopic and open colposuspension. Hong Kong Med J . 2003;9(1):10–14.
67. Burton G. A randomized comparison of laparoscopic and open colposuspension. Neurourol Urodyn
68. Burton G. A three yearprospectiverandomized urodynamic study comparing open and laparoscopic colposuspension. Neurourol Urodyn. 1997;16:353–354.
69. Carey MR, Maher C, Cronish A, et al. Laparoscopic versus open colposuspension: a prospective multicentre randomised single-blind comparison. Neurourol Urodyn. 2000;19:389–
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70. Summitt RL,Lucente V, Karram MM, Shull BL, Bent AE. Random­ized comparison of laparoscopic and transabdominal Burch ure­thropexy for the treatment of genuine stress incontinence. Obstet Gynecol. 2000;95(4):S2.
71. Huang WC, Yang JM. Anatomic comparison betweenlaparoscopic and open Burch colposuspension for primary stress urinary incon­tinence. Urology. 2004;63(4):676–681.
72. Miannay E, Cosson M, Lanvin D, Querleu D, Crepin G. Compari­son of openretropubicandlaparoscopic colposuspensionfor treat­ment of stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol. 1998;79:159–166.
73. Kung RC,Lie K,Lee P,Drutz HP.The cost-effectiveness oflaparo­scopic versus abdominalBurchproceduresin women withurinary stress incontinence. J Am Assoc Gynecol Laparosc. 1996;3(4):537–
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74. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J. 1996;7:81–86.
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77. Paraiso M, Walters MD, Karram MM, Barber MD. Laparoscopic Burchcolposuspensionversus tension-freevaginaltape:arandom­ized trial. Obstet Gynecol. 2004;104(6):1249–1258.
78. Valpas A, Kivela A, Penttinen J,et al. Tension-free vaginal tape and laparoscopic mesh colposuspension in the treatment of stress uri­nary incontinence: immediate outcome and complications – a ran­domized clinical trial. Acta Obstet Gynecol Scand 2003;82(7):665–
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Section 14.2. Minimally Invasive Slings
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Alan D. Garely and Cedric K. Olivera
More than 10 million women in the United States suffer from stressurinary incontinence.[1] Leakage ofurine during coughing, laughing, or sneezing is the most common complaint. It is esti­mated that stress incontinence and other types of urinary incon­tinence cost over$9 billion per year in health carespending.[2–4] These costs include medical and surgical therapy but also paper products for adult diapers and nursing home care.
Stress incontinence is a disease that affects quality of life. This means that activities of daily living (shopping, working, and socializing) may be curtailed, which ultimately can affect the patient’s psychological well-being. Depression is common, and afflicted individuals often isolate themselves to avoid embarrass­ing situations.[5–7] Nobody likes to smell like urine or to be around others who smell bad. Coupling this with injuries that occur from falls while trying to rush to the bathroom, especially at night, many of these people end up in nursing homes.
Significant improvement has been made in treating overac­tive bladder conditions with new anticholinergic medications. Stress incontinence has also seen tremendous improvements in treatment since theadventofthe tension-free vaginal tape(TVT). Although the TVT was the first sling of its type, other approaches and methods have continued this momentum, making stress incontinence treatment a safe, quick, and outpatient procedure.
This section discusses the pathophysiology, work-up, and treatment of stress incontinence. Unless specified, the term min- imally invasive sling (MIS) is used to discuss all the minimally invasive slings, regardless of brand or approach.
ANATOMY OF STRESS INCONTINENCE
The vagina receives its support in three dimensions (Figures
14.2.1, 14.2.2). The roof of the vagina (anterior wall) supports the bladder and the urethra. Distally, the connective tissue ante­rior to the vaginal epithelium attaches to the pubic bone. Lat­erally, the tissue (commonly called the pubocervical fascia) is attached to the arcus tendineus fascia via the fascia endopelv­ina. This arcus tendineus runs from the pubic symphysis to the ischial spine bilaterally. The obturator internus muscle and the iliococcygeus muscle (part of the levator ani) are separated by the arcus tendineus (Figures 14.2.3, 14.2.4). Anterior wall defects are called cystoceles and may be further divided into central and lateral defects.
If the anterior vaginal wall connective tissue separates from the arcus tendineus fascia on either one or both sides, this is con­sidered a lateral or paravaginal defect. If the lateral attachments are well supported but a “drop” in the anterior wall is seen, this is a central or midline defect (Figure 14.2.5).
The apex of the vagina is supported by the cardinal ligament and the uterosacral ligaments. The cardinal ligament runs across the pelvis from ischial spine to ischial spine, and lends support by encircling the cervix. This forms a critical component of the pericervical ring at the level of the ischial spines, along with the pubocervical fascia, the pubourethral ligaments, the uterosacral ligaments, and the rectovaginal septum. The cardinal ligament bridges the pubocervical fascia to the posteriorrectovaginalfascia (which serves a similar purpose on the posterior vaginal wall). The uterosacral ligaments joinposteriorlyto the cervix andattach to the sacrum.[8–10]
When the supportive tissue of the vaginal apex becomes injured or attenuated, apical support decreases and the vagina starts to invert like an inside-out pocket. This is called an entero­cele. As the apex further descends toward the introitus, the ante­rior vaginal wallusually separates from thelateralarcustendineus fascia, exacerbating the anterior wall cystocele.
Posteriorly, the vaginal connective tissue separates the rectal wall from the vaginal epithelium. Like the anterior vaginal wall, the posteriorconnective tissue is also attachedlaterally, butto the arcus tendinous via thefascia endopelvina. Breaks or attenuation of this tissue create a rectocele.
PHYSIOLOGY OF STRESS INCONTINENCE
In a normal anatomic pelvis at rest, the closure pressure of the urethra (Pu) exceeds the intravesical pressure (Pves). This means that the pressure inside the bladder is lower than the pressure inside the urethra. As long as Pu is greater than or equal to Pves, no leakage of urine should occur. It is very important for Pu to be less than Pves when needed, or otherwise normal mic­turition cannot occur. Our problem begins when Pves is greater than Pu at times in between voluntary voiding. This indicates incontinence.
Assuming the patientisnot voiding intentionally,tomaintain an intact continence mechanism, the Pu must always be greater than Pves, even under events of stress (i.e., coughing, laughing, and sneezing). In the perfectly intact pelvis, this means that the intra-abdominal pressures are equally transmitted to both the bladder and the urethra, thereby canceling out the momentary rise in pressure. This can work only if the urethra is well sup­ported. This is easy to picture by thinkingabout a garden hose on a driveway. If water is running through the hose and you step on it, the water will stop. If the same hose is placed on a trampoline, which lacks support, it is unlikely that stepping on the hose will stop the flow of water. Applying this principle to the urethra and
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Figure 14.2.1. Frontal view showing vaginal support and surrounding
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structures. (Permission granted by Gynecare.)
bladder neck, it becomes clear how a cystocele can increase the risk of incontinence.[11–13]
Not all stress incontinence will occur in the presence of a cys­tocele, and not all cystoceles are accompanied with stress incon­tinence. The urethra itself has an intrinsic resting tone, which is oftenhigh enough to compensateforlackofanteriorwallsupport. The converse of this occurs in patients with stress incontinence in whom the anterior vaginal wall support is excellent. In these cases, the intrinsic resting tone of the urethra is poor, despite a solid “backboard” (Figure 14.2.6).
The three factors known to increase the risk of developing stress incontinence are age, genetic predisposition to weak con­nective tissue (hernia formation), and a history of vaginal child­birth. Looking at each of these individually, we can see how they influence the continence mechanism.
As the pelvic floor ages, even intact support may begin to weaken. This is probably why stress incontinence increases with age. Factors such as decreased estrogen may contribute, but the studies are not conclusive and are often contradictory.
Minimally Invasive Slings 379
Figure 14.2.3. Arcus tendineus fascia pelvis (the white line). (Permis­sion granted by Gynecare.)
For reasons not completely understood, certain ethnicities appear to be at a higher risk of incontinence secondary to connective tissue strength. Although studies are ongoing, this increased risk is most likely related to collagen composition and deposition. Populations from northern Europe seem pre­disposed, whereas prevalence in African-based populations is lower.
Vaginal deliveries cause both stretching and crushing of the pelvic floor tissues, muscles, and nerves. Some women recover without any sequelae. Like a rubber band stretched to its limits, the pelvic floor does not always “snap” back to its original posi­tion. If the injury involves nerves, the intrinsic resting tone of the urethra may decrease. If it involves the muscles, a cystocele may develop, decreasing anterior wall support.
EVOLUTION OF SURGICAL REPAIR
Figure 14.2.2. 3D model showing pubocervical fascia and anterior vaginal wall support. (Permission granted by Gynecare.)
Before 1996, the approach to stress incontinence surgery was determined more by specialty than by technique and outcome. The gynecologists favored anterior repairs and retropubic ure­thropexies (MMK and Burch), whereas urologists chose needle suspensions (Stamey, Raz, and Pereyra) and open slings.
Anterior Repair
Anterior repairs (Kelly plication) are done transvaginally at the time of othervaginalsurgery and areoftencombinedwith vaginal hysterectomy and posterior repairs. These procedures rarely are performed with cystoscopy, as most gynecologists do not have privileges to use the cystoscope. The anatomic basis of the anterior repair is to plicate the connective tissue under the bladder and urethra (just anterior to the vaginal epithelium). The vaginal epithelium lying lateral to the plication is trimmed and closed with a running or interrupted absorbable suture (Figure 14.2.7). This pulls the tissue together under the midline of the anterior vaginal wall. This increased tension under the bladder neck and
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Figure 14.2.4. Iliococcygeus and obturator internus muscle forming arcus tendineus fascia pelvis. (Permission granted by Gynecare.)
urethra was thought to increase the urethral closure pressure, decreasing stress incontinence.
Two problems with this approach were long-term success rates and anatomic distortion of the vagina. Objective cure rates with more than 2 years of follow-up ranged from 54% to79% [14– 16], with some studiesshowingfailureashighas80%. Because the anterior vaginal wall is “pulled” together in the midline, the pub­ocervical fascia is also pulled off of its lateral attachment from the arcus tendineus fascia. Detaching tissue from thearcus tendineus causes the most common anterior wall defect, called a lateral cys­tocele. It is probably not a coincidence that cystoceles are asso­ciated with stress incontinence, as the bladder neck and urethra lose support. The anterior repair has a place in repairing central cystoceles, but its use in stress incontinence is not supported by the data.
Retropubic Urethropexies
Retropubic urethropexies are based on the concept of urethral stabilization. Suture is placed next to the urethra starting at the bladder neck and is often followed by additional sutures lat­eral to the urethra. These sutures are then placed through the periosteum of the symphysis (MMK) or through Cooper’s lig­ament (Burch). The suture tension is tied so that the bladder neck rests with little elevation. This is done by creating a “suture bridge” effect with the suture. The physiologic goal is to “fool” the urethra into behaving as if it were at rest during stress events (Figure 14.2.8).
In properly selected cases,successrates should begreaterthan 80% at 5 years. Although success rates are similar for the MMK and Burch, the MMK is rarely associated with osteitis pubis, an often debilitating and chronic disorder.Retropubic urethropexies require dissection of the space of Retzius (retropubic space). This
Figure 14.2.5. Central anterior wall defect known as a cystocele. (Permission granted by Gynecare.)
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Figure 14.2.6. Sling providing “backboard” support under urethra. (Permission granted by AMS.)
area frequently has a vast plexus of superficialveins that may cause a rapid and profound blood loss. Unless this area is approached laparoscopically, an abdominal incision is required.
Stress incontinence can be objectively graded ona continuum ranging from mild to severe by looking at urethral closure pres­sures or leak pointpressures.Thelowerthe pressure, the lower the intrinsic resting tone of the urethra. We know that stress incon­tinence with an objective assessment of good intrinsic urethral resting tone (higher pressure) will respond well to a retropubic urethropexy. Cases with poor urethral tone are associated with higher failure rates and should probably be treated with a sling.
Urethra
Bladder neck
Figure 14.2.8. Retropubic urethropexy (Burch). (Permission granted by AMS.)
Failures in this group occur because there is a lack of support directly under the urethra. Lateral support is just not enough to coapt the urethra during stress events.
Although cystoscopy has not been the standard of care with retropubic urethropexies,recentstudies have shown urinary tract injury rates as high as 4.9%.[17–19] These injuries include place­ment of sutures into the bladder and urethra and kinking of the ureters. Permanent suture in the bladder acts as a nidus for stone formation. Given theseinjuries, cystoscopy shouldbe required to assure decreased morbidity.
B
Pubocervical
fascia
Base of bladder
A
Figure 14.2.7. Anterior colporrhaphy. (Permission granted by AMS.)
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Needle Suspensions
In the past, urologists have favored needle suspensions. Sutures are placed next to the bladder neck and urethra (like a retropubic urethropexy) and then anchored to the rectus fascia instead of the pubic symphysis. Depending on the way the suture is secured next to the bladder neck (whether with a pledget or just suture) determines the name of the approach (Raz, Stamey, or Pereyra). The sutures are pulled up to the rectus fascia with a “needle.” The needle is a long, thin metal rod that is sharp enough to puncture through the intervening layers between vagina and rectus. This approach also requires an abdominal skin inci­sion.
Overall success rates for needle suspensions are 81%.[20–22] This rate islowerthan that ofretropubicsuspensions at 85%.[20– 22] The limitations for needle suspensions are similar to those for the retropubic urethropexies, including the lack of direct sub­urethral support. Although the MMK and Burch are “fixed” to immobile tissue, the needle suspensions are totally dependent on mobile, distensible tissue. This contributes to failure on two fronts. First, it gives two separate places for suture to pull or rip out. Second, it gives two places for the soft tissue to stretch, decreasing the ability to support the urethra.
Placement of the sutures with the needle is done blindly and with a tactile feel for anatomic landmarks. Cystoscopy must be performed after each pass of the needle to ensure urinary tract integrity.
Open Slings
Before theadvent of the MIS, the traditional sling wasconsidered the domain of the urologist or specially trained urogynecologist. This “open” sling required opening the vaginal epitheliumunder the bladder neck, cutting the abdomen, and placing a sling or hammock under the bladder neck and urethra (Figure 14.2.9). Although many materials were used for the sling, the most com­mon material was autologous fascia or muscle. Fasciawas usually taken from the upper thigh (fascia lata) or the abdomen (rectus
Figure 14.2.9. Sling underbladderneck. (Permission granted byAMS.)
fascia). The rectus muscle was used because of its proximity to the vagina. The sling wasthen brought above the rectusfascia and then tied either to the fascia or across the midline to the other end of the sling.
Because the sling was tied down, the risk of urinary retention was high. Traditional slings were also associated with infections and blood loss because of the dissection needed to properly place the sling. When certain nonabsorbable materials were used as the sling substrate (mesh made of Prolene, Marlex, Gore-Tex, etc.), erosion into the urethra and vagina was common. Muscle herni­ation was also notedin theupper thigh and abdomen, depending on the site of fascial harvest.
Traditional slings may be used for treatment of the entire range of stress incontinence, and success rates can exceed 85%. This “take-all-comers” flexibility, along with a high success rate, served as the impetus for developing a safer, easier, and faster sling. This would also include making the sling “minimally invasive.”
MINIMALLY INVASIVE SLINGS
The advent of the MIS was initially met with a high degree of skepticism. Long-term success was unknown. Placing the sling at the mid-urethra instead of the bladder neck was a new idea. The choice of material was also controversial given the history of urethral erosions with Prolene mesh. Medical “politics” also contributed to doubts about the MIS. Urologists had been the surgeons doing slings, but the MIS was developed by a gynecolo­gist and was being taught to gynecologists. The rate-limiting step of the procedure that kept it from most gynecologists was the absolute need to do a cystoscopy during the case.
Westby andother authors [23–25] postulated thatwhenlook­ing at a urethral pressure profile, the mid-portion of the urethra has the highest resting closure pressure. It is easier to augment coaptation at the area that already has the highest intrinsic pres­sure. Anatomically, support of the mid-urethra causes less dis­tortion and less “kinking” than does support at the distal meatus or at the bladder neck.
By applying the principles of tension-free surgery, the sling is placed under the urethra, with a spacer temporarily interposed between sling and urethra. The sling is then pulled through the intervening tissue and not tied or secured to any tissue. This is the crucial step in the “tension-free” description.
Sincethe first TVT was introduced by Ulmsten,several similar devices have come to market. The first generation of MIS was based on retropubic placement. The main differences between each proprietary sling are in the weave of the mesh, the type of material used, and whether the sling is placed by pushing the mesh from the vagina through the abdominal incisions or the mesh is pulled up from the abdominal side.
The second-generation MIS used a transobturator approach instead of passing through the retropubic space.[26–28] Again, different proprietary products strive to achieve the same result with variations on material and on direction of place­ment.
The third generation of MIS is readjustable. This allows the sling to be tightened or loosened either during the surgery or at any time after. All three types of sling are described in detail in the following paragraphs.
Figure 14.2.10. First-generation TVT device. (Permission granted by
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Gynecare.)
TENSION-FREE VAGINAL TAPE
In1998, Ulmstenet al. presented“A Multicenter Study of Tension­Free Vaginal Tape (TVT) for Surgical Treatment of StressUrinary Incontinence.”[29] It was noted by Ulmsten that “a long series of experiments proceeding the current TVT operation have shown that placing a sling under the midurethra without tension is the best way to provide a dynamic kinking of the organ, and hence to close the urethra in stress situations.”[30–32] This led to a patent by Dr. Ulmsten and subsequent sale of the device to Johnson & Johnson. The device is marketed under the name TVT (Figure
14.2.10).
Preoperative Evaluation
No patient should ever have a stress incontinence procedure unless stress incontinence is visually witnessed. Without actu­ally seeing the leakage, you run the risk of operating on a patient who really has urge incontinence. If the patient does not have stress incontinence,herurge incontinencesymptomsmayworsen because of the obstruction placed on the urethra. Although bed­side urodynamic evaluation done with a simple catheter and syringe are usually reliable, complex testing should be done to help aid in determining the final tensioning of the sling. Patients with very low leak point pressures will probably need the sling to abut the suburethral tissue, whereas patients with higher leak point pressures can have the sling placed looser.
Slings work best when placed under the urethra in the pres­ence of a well-supported anterior vaginal wall. Although it is difficult to quantitate when a cystocele is too big, the surgeon must be mindful that the anterior vaginal wall will not rotate around the sling (which stabilizes the urethra) like a fulcrum, contributing to urethral kinking and urinary retention. Proper surgical planning may mean that the patient is not a candidate for anisolated sling but may require a larger pelvic reconstructive surgery.
Although slings may be considered minor outpatient proce­dures, they are still surgical procedures done with anesthesia and associated risks. These operations should be taken seriously, with
Minimally Invasive Slings 383
great attention paid to the patient’s medical history and med­ications. Proper planning will help ensure a safe and effective operation.
Technique
When doing these cases for the first time, general anesthesia is essential. This will keep the patient absolutely still, allowing the surgeon to concentrate on the dissection and placement of the sling. Even in the hands of an experienced surgeon, a moving patient makes it hard to achieve an optimal outcome. After the surgeon is comfortable with the procedure, a combination of local anesthesia with sedation may be attempted if necessary. The entire procedure should take less than an hour, and patients recover rapidly with few side affects from general anesthesia. If the sling is to be done with other gynecologic procedures, local anesthesia with sedation may not be possible.
Local anesthesia with epinephrine is given to all patients regardless of whether the procedure is done under general anes­thesia or sedation. The epinephrine will greatly reduce blood loss by causing vasoconstriction. The local component will decrease pain sensation by numbing the pain receptors prior to incision. Vasopressin may also be substituted for the epinephrine compo­nent to achieve hemostasis.
The patient is brought to the operating room and placed in the dorsal lithotomyposition. Positioningthepatient’s buttock a little lowerthanusualwillaidinvisualizationofthefieldand placement of the sling. The patient is prepped and draped for combined abdominal/vaginal approach surgery. The drape should also have a cysto bag to help prevent a flood during the cystoscopy portion of the procedure.
A preoperative dose of antibiotic should be given intra­venously. A weighted speculum is placed in the vagina to expose the anterior vaginal wall. A marking pen is used to make two 0.5­cm marks5 cm apart, symmetric to the midline, at thelevel of the pubic symphysis. Lidocaine with epinephrine or Marcaine with epinephrine should be injected at the marked spots and into the retropubic space along the pubic symphysis. The same anesthetic should be injected under the urethra and lateral to the urethra aiming at the ipsilateral shoulder. An 18F Foley catheter should then be placed into the bladder and allowed to drain the urine. Placing the catheter before injecting can inadvertently cause the catheter balloon to pop, requiring a new Foley.
A #14 surgical knife should be used to make small puncture incisions at the marked spots on the abdomen. The knife should then be used to cut a 3-cm vertical incision under the urethra starting just distal to the urethra vesical junction. Using a very sharp plastic surgical Metzenbaum or tenotomy scissors, flaps should be gently developed on the left and right sides of the mid­line incision. Injuries that occur with sharp dissection are almost always easier to repair than those created with blunt dissection or spreading. Care should be taken not to go too deep, as this may cause immediate entry into the urethra or bladder, or may contribute to delayed erosion in these structures. Superficial dis­section may lead to cutting through the vaginal epithelium. This is called a “button hole.” A button hole makes it easy to place the sling through the inside of the flap, out into the vagina, and then back into the flap. This will leave the patient with a small piece of exposed mesh in the vagina. Dissection should stop short of perforating into the retropubic space (Figure 14.2.11).
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Figure 14.2.11. Initial dissection of vagina for placement of a midurethral sling. (Permission granted by AMS.)
The rigid catheter guide is placed into the Foley, and the catheter is deflected to the same side that the first needle will be passed. Assuming the first pass is on the left side, the Foley is deflected to the left. Because of limited space, the catheter and guide maybeclampedontothedrape at an angle slightly above the horizontal plain of the urethra. The rigid catheter guide deflects the uterovesical junction away from the TVT needle when it is passed. This decreases the risk ofinjury to the urethra and bladder (Figure 14.2.12).
The TVT device consists of two separate needles swedged onto either end of a strip of Prolene mesh. This is covered by two overlapping pieces ofa plasticsheath. The overlappingarea of the two sheaths can be clamped with one click from a hemostat to prevent early separation of the sheaths. This decreases the pos­sibility that the mesh will twist or stretch. Other than aiding in sling placement, the sheath protects the sling from exposure to vaginal flora, thereby decreasing the risk of surgical infection in the surrounding tissue (Figure 14.2.13).
Figure 14.2.13. TVT with sheath. (Permission granted by Gynecare.)
The TVT needle on one side is screwed tightly into the reusable TVT handle. Using a toothed forceps, the cut vaginal edge on the left side is lifted. Working in the left flap, the sur­geon should use his or her left hand to hold the TVT handle and position the tip of the needle into the flap. With the surgeon’s right hand, two fingers should be placed into the vagina, out­side the flap. The right hand should then cradle the curve of the TVT needle, aiming it at a 45
angle toward the left shoulder. The tip should be adjacent to the pubic symphysis. The surgeon’s left hand should be exerting gentle pressure while the right hand guides the needle into the retropubic space (Figure 14.2.14).
Once the pubocervical fascia is perforated, a “give” should be palpated and the pushing halted. This indicates that the TVT needle tip is safely anterior and lateral to the urethra andbladder. The angle of the TVT handle should then be corrected to aim toward the patient’s head and not the shoulder. The tip can be gently “walked” off the symphysis with a touch-and-push tech­nique (Figure 14.2.15).
Figure 14.2.12. TVT Foley catheter guide. (Permission granted by Gynecare.)
Figure 14.2.14. Placement of the TVT needle. (Permission granted by Gynecare.)
Figure 14.2.15. TVT needle next to pubic bone. (Permission granted by AMS.)
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Minimally Invasive Slings 385
The surgeon shouldidentify his orher incision onthe left side of the patient’s abdomen and aimfor that spot. With a littleeffort, the TVT needle should be easily pushed through theincision and the procedure halted. Therigid catheter guideshould be removed and the Foley opened to drainage. Evaluation of urine color may sometimes signal a bladder perforation. Even in the presence of a perforation, the urine is often clear because the injuries are small and do not always bleed. The bladder should be filled with a least 300 mL of water, but more fluid is preferable as it is easy to miss “in–out” injuries in the bladder that catch a small area of tissue. A 70
cystoscope should be used to visualize the bladder and urethra. Most bladder injuries occur at the 10 and 2 o’clock positions.[33–35] If an injury is detected, the needle should be removed, the bladder emptied, and the entire procedure for that side restarted. Gentle movement of the TVT handle should show the TVT needle gliding in the tissue lateral to the bladder. If the tissue moves with the needle, the placement is probably too close to the bladder, and the needle should be removed and replaced.
If the needle was well placed, the bladder is emptied with the Foley, and the TVT handle is unscrewed from the TVT needle. The needle is pushed up, pulled through the abdominal incision, and left to rest on the abdomen.
The rigid catheter guide is reinserted into the Foley, and the same procedure is done on the right side, but with reversal of the surgeon’s hands and displacement of the catheter guide to the right side.
Once both needles are safely resting on the abdomen, the surgeon or assistant can slowly pull up equally on both needles until the sheath is about 2 cm from the urethra. The hemostat may be removed, and a spacing device should be placed between the sheath and urethra. The wide part of a closed Metzenbaum or a #8 Hegar dilator may be used. The needles should be cut free from the sheaths and mesh. The sheath on each side should be grasped with a Kelly clamp. To avoid injury to the mesh, one arm of the clamp is placed on the outside and one arm on the inside of the sheath (Figure 14.2.16).
While the surgeon holds countertraction between the sheath and the urethra, the Kelly clamps are pulled upward, causing the sheaths to separate in the midline, leaving the mesh sitting under the urethra with no “tension” (Figure 14.2.17).
The mesh is cut at the abdominal incisions, pulling up gently on the mesh and pushing down with the suture scissors on the skin. This ensures that the mesh does not irritate the incision site. The mesh is inspected and palpated through the vaginal incision to ensure that it is not too tight. The vaginal incision is then closed with a 2-0 absorbable running, nonlocking suture. The skin incisions can be closed with Dermabond (Ethicon, Inc.; Figure 14.2.18).
Personal preference will determine how and when the Foley catheter is removed. Some surgeonswill leave the operating room with the Foley outand then wait up to4 hoursor until the patient
Figure 14.2.16. TVT sheaths grasped with Kelly clamps. (Permission granted by Gynecare.)
386 Alan D. Garely and Cedric K. Olivera
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Figure 14.2.17. Midurethral placement oftension-freemesh. (Permis­sion granted by Gynecare.)
feels the need to void (whichever comes first)to do apassivevoid­ing trial. If the patient is able to void, the bladder is catheterized within 15 minutestocheckfor the postoperative residual. A resid­ual less than 75 mL is usually considered acceptable.
Others will leave the Foley in place at the completion of the case and then wait about 1 to 2 hours before doing an active voiding trial. This involves filling the bladder with water through the Foley until the patient feels full, or until at least 200 mL is instilled. The catheter is removed, and the patient voids within 15 minutes into a graduated hat or cup. The voided amount is subtracted from the instilled amount for the postvoid residual. Experience has shown that the surgical assistants and recovery room nurses who manage these patients prefer the active voiding trial as it creates less work for them.
Variations
The SPARC device (American Medical Systems) is also a retrop­ubic MIS but uses the “top-down” approach. Instead of pushing
Figure 14.2.19. SPARC system. (Permission granted by AMS.)
the mesh upthrough the abdominalincisions,the SPARC needles are pushed down into the anterior vaginal wall incision and the mesh is pulled up. Urologists who have experience with needle suspensions often feel more comfortable with this approach than through the vagina (Figure 14.2.19).
Numerous studies have shown that the SPARC has success and complication rates similar to those for the TVT.[36,37] One study showedalowersuccessrate,butthishasnot been duplicated in other studies.[38] Because of the learning curve needed for all these procedures, it is difficult to judge outcome unless the surgeon has extensive experience with aspecific technique before initiation of a study.
Figure 14.2.18. Sutureless closure of incision with glue. (Permission granted by Gynecare.)
TRANSOBTURATOR TAPE
In 2001, an article was published by Delorme [26] that described the next generationofsuburethral slings. Becauseofthe anatomic position, this was called the transobturator urethral suspen­sion or transobturator tape (TOT) procedure. The original abstract states: “This tapehastwooriginal features: its non-woven polypropylene structure is coated with silicone on the urethral surface inorder to limitretraction ofpolypropylene and to estab­lish a barrier to extension of periurethral fibrosis. Transmuscular insertion, through the obturator and puborectalis muscles, repro­ducesthenaturalsuspensionfasciaoftheurethrawhilepreserving the retropubic space”(Figures 14.2.20, 14.2.21).
The concept of avoiding the retropubic space was very appeal­ing for many reasons. Most complications associated with the TVT procedure (see below) would be decreased, if not elimi­nated. Going through the obturator fossa would be associated with a new set of problems, but anatomically, none seemed as