Purpose: We describe the new outpatient Burch-Sling procedure (without utilizing laparotomy or laparoscopy as a nerve sparing technique) for the correction of genuine stress urinary incontinence. This surgical approach prevents injuries to somatic and autonomic nerve fibers.

Materials and Methods: One hundred-fifty women (n=150) with genuine stress urinary incontinence were recruited into this non-randomized surgical trial. All of the women completed a standardized questionnaire including degree and pattern of incontinence. Their responses were compared to the post-surgery responses. This is a retropubic bladder neck suspension procedure using a newly invented and F.D.A.-approved Bladder Saver Device. The vagina is elevated bilaterally at the urethrovesical junction to reposition the proximal urethra toward Cooper’s ligament with permanent sutures. The vaginal wall is used as an endogenous suburethral sling.
Results: There were no major complications such as bladder perforation, bowel injury, or hematoma during the procedure. The patients were followed-up from six months to eight years. Only one patient showed no improvement. Long-term follow-up of the endogenous sling did not require re-operation due to loosening.

Conclusions: The probability of nerve injury due to vaginal surgery is greater during traditional incontinence procedures because of extensive anterior vaginal wall dissection. The unique features of our outpatient Burch-Sling technique are the absence of anterior vaginal wall dissection, use of an endogenous sling for colpo-urethropexy and Cooper’s ligament is used to anchor the suspension sutures. This minimally invasive, outpatient, closed Burch-Sling procedure utilizing an F.D.A.-approved Bladder Saver Device allows performance of a time-proven operation with very little morbidity.

Introduction:
Urinary incontinence has been reported to affect 10-25% of women under the age of 65, 15-30% of non-institutionalized women over age 60 and more than 50% of nursing home residents. The incidence of this disorder is expected to increase as the population ages. Operative techniques should be reserved for women who decline or do not improve with conservative therapies. Ideally they should have completed childbearing1. Anterior colporrhaphy (Kennedy-Kelly Plication)2, traditionally various suburethral sling procedures and vaginal needle suspensions (Pereyra, Stamey, Gittes) are the existing corrective surgical procedures for genuine stress urinary incontinence.
The anterior colporrhaphy is a procedure in which urethral hypermobility is corrected, but may not provide adequate long-term support of the urethrovesical junction. When using this technique, care must be taken to dissect the anterior vaginal wall from the endopelvic fascia literally without carrying the dissection beneath the fascia to avoid excessive plication of the urethra which may produce necrosis3. The general opinion today is that anterior colporrhaphy or Kelly urethral plication technique should not be used4 because it has the potential of doing harm to the delicate tissue of the urethral sphincter mechanism2, 5. No one disagrees that the most extensive dissection of the anterior vaginal wall around the urethra and junction is made at the time of performing sling or needle suspension. Another traditional method for the correction of urinary incontinence is the suburethral sling. In these techniques the urethra is exposed by a midline incision. Lateral tunnels at the level of the bladder neck are made by a combination of careful shear and blunt dissection. Freeing of the urethra and bladder neck should be generous so as to allow upward travel of the urethra when the sling is fixed in position5. Vaginal needle suspensions (Pereyra, . Stamey, Gittes) is another technique frequently performed. All except Gitte involve extensive anterior wall dissection up to the pubic bone5 or tendinous arc6. All involve anchoring the suspension sutures to the rectus fascia through a suprapubic incision2, 5. The long-term success rate of this procedure may be compromised because of the tendency of the sutures to pull through this weaker tissue5 (compare with Cooper’s ligament). In addition, there is up to a 16% chance of ilioinguinal nerve entrapment7. The greatest objection to the modified Pereyra procedures pertains to the fact that extensive dissection and pubourethral suturing may produce significant bleeding and poor visibility, and could cause urethral denervation or devascularization2, 8.
These dissections may harm the delicate nerves of the urethral sphincter mechanism, clitoris vestibule and vagina since nerves pass through the dissected area1, 6. More vexing problems after the sling techniques appear later, including mesh infection and rejection, incurable urethral obstruction4 and failure of the technique to cure incontinence.
Awareness of the precise anatomical location of the somatic and autonomic nerve supply to the urethral sphincters, clitoris, labiuim majus6, vagina4, 9 is vital to avoid injury during needle suspension or the sling procedure (Figure 1). A general lack of neuroanatomical knowledge makes these nerve branches susceptible to injury during the dissection. Our outpatient Burch-Sling procedure avoids unnecessary dissection of the anterior vaginal wall, and provides a physiological sling4, 5 without risk of tissue rejection and with a lower possibility of postoperative infection.

Materials and Methods:
After preoperative work-up and diagnostic confirmation, appropriate anesthesia is instituted. The patient is placed in a wide lithotomy position. The lower abdomen and pelvis are prepped and draped in a routine manner. A weighted speculum is placed into the vagina. Bladder evacuation is done with a Foley catheter (No. 16 to 18). The Foley catheter bulb is fixed inside the bladder after injection of 8-10 ml. of normal saline. Traction on the Foley catheter facilitates the identification of the urethrovesical junction10 and the catheter can be used to control the length and caliber of the urethra.
A No. 2 nonabsorbable suture is placed into the vaginal epithelium, 1 to 1.5 cm lateral to the urethrovesical junction by using a Mayo needle. The same procedure is repeated on the opposite side. Next, transverse incisions measuring 2.5 cm are made bilaterally on the bony edge of the iliopectineal line or pecten pubis, approximately 3 cm lateral to the midline (Figure 2, inset). This incision placement avoids injury to the inferior epigastric vessel6. Ilioguinal nerve entrapment is also avoided. The incision is carried down until reaching the bony edge of the iliopectineal line.
The Bladder Saver device is gently positioned at the edge of the iliopectineal line, and the double-pronged trocar with sleeve is passed through Cooper’s ligament and through the space of Retzius under direct finger guidance (Figure 2). The double-pronged trocar is then withdrawn and the sleeve is left in place. The ligature carrier is then passed through the inner sleeve of the Bladder Saver Device. One end of the previously placed suture is threaded through the eye of the ligature carrier and withdrawn to the inner side of the suprapubic incision and tagged with a hemostat clamp. The ligature carrier is then passed through the outer sleeve of the Bladder Saver Device, and the other end of the suture is brought to the outer side of the suprapubic incision (Figure 3).
The same procedure is repeated on the opposite side. The tying of the suspension sutures should be delayed until after cystoscopy. Cysto-urethroscopy is then performed to ensure that there has been no injury to the bladder. The rigid cystoscopy will assist in confirming that adequate support has been given to the urethra and bladder neck. The lateral aspect, particularly the 3 o’clock and 9 o’clock views of the urethrovesical junction and lower bladder must be seen clearly with no oozing or bleeding, and no suture violation. If the suspension sutures have penetrated the bladder wall, the suture should be removed and the procedure repeated.
The suprapubic bladder catheter is placed using cystoscopy for verification of its introvesical position. The catheter is then fixed to the abdominal wall skin with several sutures to prevent dislodgment or extravasation.
The last step is tying of the suspensory sutures into Cooper’s ligament (Figure 3). Use of the surgeon’s own fingers (rather than an assistant’s) to elevate the urethrovesical junction is strongly recommended. Moderate tension is required to furnish the support necessary to treat stress urinary incontinence.
A video film of this procedure has been made and is supplied by the American College of Obstetricians and Gynecologists5.[as a good teaching tool]

Results:
This procedure has been performed on one hundred-fifty women (n=150) who were referred to our urinary incontinence clinic. The diagnosis of stress urinary incontinence was confirmed in each instance by well-established criteria. All women completed a standardized questionnaire regarding over all health, sexual function, history, degree and pattern of the incontinence. Their responses were compared to the post surgery responses gathered by telephone follow-ups. All patients were provided informed consent. The mean age was 57.5 years (range, 33 to 83 years), mean weight was 185 pounds, and mean height was 65 inches. The total operation time averaged 40 minutes. All women were treated with an outpatient modified Burch-Sling procedure using the F.D.A.-approved Bladder Saver device.Success rate at first three years after correction , more than 90%.
No patient exhibited suture abscess or wound infection. There were no postoperative vaginal granulomas, vesicovaginal fistulas, hematomas or nerve damage. Self-catheterization was not needed and there were no cases of steitis pubis11. One patient remained incontinent.
Follow-up was six months to eight years. Patients were questioned about urinary incontinence symptoms and were tested at six-month follow-up. There were no readmissions to hospital for urinary tract problems. Long term follow-up of the endogenous sling, which has been used for the colpo-urethropexy, did not require re-operation due to loosen up effect.

Discussion:
During the past forty years, many studies in the medical literature have shown that the Burch procedure5 is better and less traumatic than various needle or sling procedures. The likelihood of nerve damage is greater during traditional incontinence procedures because of their extensive anterior vaginal wall dissection. Also, use of the recent tension-free vaginal tape procedure holds the risk of major vascular injuries12.
Ulmsten et al from Europe described the tension-free vaginal tape or TVT procedure as a kind of sling procedure.
In this technique the anterior vaginal and abdominal wall incisions are used plus dissection to develop lateral periurethral spaces to the inferior pubic ramus the polypropylene mesh is placed at the midurethra13.
A curved 5 mm needle is placed transvaginally through periurethral endopelvic fascia. This technique of needle passage has resulted in major vessel injuries and retro pubic hematomas the generally have not been seen with other sling procedures. Eventually, the needle was inserted through the urogenital diaphragm. After piercing the urogenital diaphragm, the needle was angled to ascend vertically through the retro pubic space with the surgeon trying to maintain contact with the back of the pubic symphasis. The needle was brought up through the abdomen at the small incision site and clamped in place with a Kelly clamp. The second needle was inserted on the contra lateral side in a similar fashion and clamped in place with a Kelly clamp.
Kulva and Nilsson presented an analysis of TVT complications in Finland based on 1455 cases at 38 hospitals14.

Long-term results with TVT on mixed and stress urinary incontinence indicate that initial good cure rates do not persist after 4 years.
The transobturator tape procedure or TOT is a alternative to the tension-free vaginal tape of TVT with needle passage during the outside in transobturator approach, the needle tip penetrates the obturator externus muscle, the obturator membrane, and the rotate around the medial aspect of the inferior pubic ramus, skimming the obturator internus muscle. It is then contacted by the surgeon’s finger and exited through the vaginal incision under direct finger guidance15.
Manufacturer and use facility device experience (MAUDE) database to identify all complications reported with the use of TOT techniques available in the United States16. MAUDE was found in the categories of infection, neuropathy, and bleeding, she reported. The study revealed 173 reports of complications in 140 patients from January 2004 to January 2005.

We have demonstrated that the modified Burch procedure can be performed on an outpatient bases with minimal to no postoperative complications. Additionally, it has been demonstrated that during correction of the urinary incontinence, avoiding dissection of the anterior vaginal walls has spared the nerves. This new outpatient Burch-Sling surgical approach for the correction of genuine stress urinary incontinence specifically prevents injuries to somatic nerve fibers such as the external urethral sphincter nerve, the dorsal nerve of the clitoris, the posterior nerve of the labia majora, the posterior nerve of the labia minora, and finally, the vaginal nerves from the autonomic nerve division. Other important features of this technique are the use of an endogenous sling for colpo-urethropexy and the utilization the edge of the iliopectineal line to anchor the suspension sutures.

Conclusions:
We have successfully demonstrated in this study that outpatient modified Burch-Sling results in significant improvement in stress incontinence and voiding dysfunction without injuries to the somatic and autonomic nerve fibers. The outpatient Burch-Sling procedure using an F.D.A. approved-Bladder Saver Device is now available. This offers a major advancement in surgery for female genuine urinary stress incontinence because it reduces the risk of nerve injury (and other possible complications). We would like to recommend this innovative and beneficial procedure and the Bladder Saver Device instrument for the repair of genuine stress urinary incontinence.

References
1. Samimi, D.: The Closed Burch procedure ? outpatient ? with no laparotomy or laparoscopy. Presented at the ACOG ACM, New Orleans, 1998
2. Samimi, D.: Outpatient Burch-Sling procedure ? a nerve sparing method for correction of female urinary incontinence. Presented at the ACOG ACM, Los Angeles, 2002
3. Cherry, S., Berkowitz, R., Kase, N.: Rovinsky and Guttmacher’s Medical Surgical and Gynecologic Complications of Pregnancy, 3rd ed. Baltimore: Williams & Wilkins, 1985
4. Amundsen, C., Guralnick, M., Webster, G.: Variations in strategy for the treatment of urethral obstruction after a pubovaginal sling procedure. J Urol, 164: 434, 2000
5. Samimi, D.: VHS short film: Outpatient Burch-Sling procedure ? a nerve sparing method for correction of female urinary incontinence. Presented at the ACOG ACM, Los Angeles, 2002
6. Novick, A.: Stewart’s Operative Urology, 2nd ed. Baltimore: William & Wilkins, 1989
7. Kelly, M., Zimmern, P., Leach, G.: Complications of bladder neck suspension procedures. Urol Clin North Am, 18: 339, 1991
8. Samimi, D.: Randomized clinical trial of intrastromal abdominal hysterectomy, bloodless nerve sparing TAH. Presented at the ACOG ACM, New Orleans, 2003
9. Shafik, A., Doss, S.: Surgical anatomy of the somatic terminal innervation the anal and urethral sphincters: role in anal and urethral surgery. J Urol, 161: 85, 1999
10. Drukker, B., Miller Jr., D.: Retropubic urethropexy by the vaginal wall technique in stress urinary incontinence. Clin Obstet Gynecol, 21: 775, 1978
11. Ball Jr., T., Teichman, J., Sharkey, F. et al.: Terminal nerve distribution to the urethra and bladder neck: considerations in the management of stress urinary incontinence. J Urol, 158: 827, 1997
12. Muir, T., Tulikangas, P., Paraiso, M. et al.: The relationship of tension-free vaginal tape insertion and the vascular anatomy. Obstet Gynecol, 101: 933, 2003
13. Karran, Micky M., Segal, Jeffery L., et al.: Complications and untoward effects of the TVT procedure. Obstet Gynecol, 101: 933, 2003
14. Kuava and Nilsson presented Analysis of TVT Complications, Obstet Gynecol, 2005
15. Rajan and Kohli, Pelvic hematoma with TOT, Harvard Med School, Obstet Gynecol, 2005
16. Manufacturer and user facility device experience (MAUDE) database to identify all complications reported with the use of TOT, Dec. 1, 2005