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	Dr. Daryoosh Samimi, M.D., F.A.C.O.G. Researcher - Inventor Pioneer of Techniques in Nerve Sparing Gynecologic Urogynecologic Surgery Director of US Women Institute 11160 Warner Ave #117 Fountain Valley, Ca. 92728-9870 1-888-4Female Fax (714) 754-4401	Office Goal This site is devoted to the presentation of techniques in Nerve Sparing Gynecologic Surgery pioneered by Dr. Dary Samimi, M.D., F.A.C.O.G. These techniques are done as an outpatient surgical procedure sometimes under local anesthesia. These techniques and the medical device(s) used to assist with the procedure, were created and patented by Dr. Dary Samimi, M.D., F.A.C.O.G., research-Invention, of Fountain Valley, California, USA.
Office Location: 11160 Warner Ave #117 Fountain Valley, Ca. 92728-9870 1-888-4Female Fax (714) 754-4401

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OUTPATIENT BURCH-SLING PROCEDURE:
A NERVE SPARING METHOD FOR CORRECTION OF FEMALE URINARY INCONTINENCE
USING A NEWLY INVENTED AND F.D.A. APPROVED
BURCH-SLING DEVICE

DARY SAMIMI, M.D., ET., AL.

Objective:
The purpose of this paper is to evaluate and report a new technique and our experience performing the Outpatient Burch-Sling Procedure (without utilizing either Laparotomy or Laparoscopy as a nerve sparing technique). Additionally, we will describe this new surgical approach for the correction of genuine stress urinary incontinence, which 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 never of the labia minora, and finally, the vaginal nerves from the autonomic nerve division.

Methods:
One hundred and 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 regarding overall health, sexual function, history, and degree and pattern of incontinence. Their responses were compared to the post-surgery responses gathered by telephone follow-ups. This is a retropubic bladder neck suspension procedure using a newly invented and F.D.A.-approved Bladder Saver Device. In this technique, the vagina is elevated bilaterally at the urethrovesical junction. This repositions the proximal urethra within the abdominal cavity toward Cooper’s Ligament with permanent sutures. In this method, 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. There was only one patient who showed no improvement. The patients were followed-up from six months to eight years. 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. Long-term follow-up of the endogenous sling did not require re-operation due to a loosening.

Conclusion:
There are many references in the medical literature describing nerve injury due to vaginal surgery. The likelihood of damage is greater during traditional incontinence procedures because of extensive anterior vaginal wall dissection. The unique features of our techniques are the following:

It may be performed as an outpatient procedure.
Absence of anterior vaginal wall dissection.
Use of an endogenous sling for colpo-urethropexy.
Cooper’s Ligament is used to anchor the suspension sutures.

Urinary incontinence has been reported to affect 10-25% of women under the age of 65, 15-30% of noninstutionalized 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 childbearing. [6,10] Anterior colporrhaphy (Kennedy-Kelly Plication), [5,14] traditionally various suburethral sling procedures and vaginal needle suspensions (Pereyra, Raz, 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. [5] When using this technique, care must be taken to dissect the anterior vaginal wall from the endopelvic fascia literally [19] without carrying the dissection beneath the fascia to avoid excessive plication of the urethra which may produce necrosis. [3,19] The general opinion today is that anterior colporrhaphy or Kelly urethral plication technique should not be used1 [3,17] because it has the potential of doing harm to the delicate tissue of the urethral sphincter mechanism. [15,14] 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 position. [6,15] Vaginal needle suspensions (Pereyra, Rax. Stamey, Gittes) is another technique frequently performed. All except Gitte involve extensive anterior wall dissection up to the pubic bone [15] or tendinous arc. [4,5] All involve anchoring the suspension sutures to the rectus fascia through a suprapublic incision. [14,15] The long-term success rate of this procedure may be compromised because of the tendency of the sutures to pull through this weaker tissue [5,15] (compare with Cooper’s ligament). In addition, there is up to a 16% chance of ilioinguinal nerve entrapment. [21] 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 devascularization. [14,16]

These dissection may harm the delicate nerves of the urethral sphincter mechanism, clitoris vestibule and vagina since nerves pass through the dissected area. [1,4,10] More vexing problems after the sling techniques appear later, including graft infection and rejection, incurable urethral obstruction [13] 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 majus, [4] vagina [12,18] 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. The Outpatient Burch-Sling avoids unnecessary dissection of the anterior vaginal wall, and provides a physiological sling1 [3,15] 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 junction, [2] and the catheter can be used to control the length and caliber of the urethra.

A No. 2 monofilament nylon 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 iliopectincal line or pecten pubis, approximately 3 cm lateral to the midline (Figure 2). This incision placement avoids injury to the inferior epigastric vessel. [1,4] 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. 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 (Figure 3). The ligature carrier is then passed through the outer sleeve of the Bladder Saver, and the other end of the suture is brought to the outer side of the suprapubic incision.

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 4 A, B, C). 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 s available to members on Dr Samimi's web site: http://888-4female.com .

RESULTS:
This procedure has been performed on one hundred and 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. [6] 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 FDA approved BladderSaver device.

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 pubis. [9] One patient remained incontinent.

Follow-up was six months to eight years. Patients were questioned abount 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 its loosen up effect.

DISCUSSION
During the past forty years, many studies in the medical literature have shown that the Burch procedure [5,15] 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. 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. Other important features of this technique are the use of an endogenous sling for colpo-urethropexy and the utilization of Cooper’s ligament to anchor the suspension sutures. 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 nerve fibers. The Outpatient Burch-Sling using an F.D.A. approved BladderSaver Device is now available. This offers a major advancement in surgery for female 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 instrument for the repair of genuine stress urinary incontinence.

References


1.  Warwick R., Williams P.L., Moore R.E., Bannister L.K., Standring S.M.,
    Rees E.L., et al. Philadelphia: W.B. Saunders Company, 1980.
2.  Drukker, G.H., Fantl J.A.  Retropubic urethropexy for urinary stress.  
    incontinence.  Ob-Gyn Illust. 1983; 4: 1-15
3.  Cherry S.H., Berkowitz R.L., Kase N.G., eds.  Rovinshy and Guttmacher’s
    Medical, Surgical, and Gynecologic Complications of Pregnancy, 3rd ed.
    Baltimore: Williams & Wilkins, 1985.
4.  Stewart, S. Operative Urology, 1989.
5.  Nicolette S. Horbach.  Genuine SUI: Best surgical approach.
    Contemporary OB/GYN vol. 37-192, 1992.
6.  Hurt, W.G., Raz, S.  Vaginal surgery for urogenital problems.
    Clin Dialogue Female Urol 1992; 3: 1-16.
7.  Ostergard, D.R., Bent, A.E.,  Urogynecology, Danforth’s OB-GYN 1994.
8.  Tanagho, E.A.   Colposystourethropexy, the way we do it.
    J.URO 1996, 116: 751-3.
9.  Ball T.P., Jr., Treichman J.M., Sharkey F.E., Rogenes V.J., Adrian E.K., Jr.
    Terminal nerve distribution to the urethra and bladder neck:
    Consideration in the management of stress urinary incontinence.
    J. Urol 1997; 158: 827-829.
10. Samimi, Dary, MD.  The Closed Burch Procedure, Outpatient, with
    No Laparotomy or Laproscopy.  ACOG, ACM, New Orleans, Lousiana.  1998
11. Campbell, S. Urology Sevth & Ditition Chapter 32, 1998.
12. Shafik A., Doss S.  Surgical anatomy of the somatic terminal innervation
    the anal and urethral sphincters:  Role in anal and urethral surgery.
    Urology 1999; 161: 85-89.
13. Amundson, C.L., Guaralnick, M.L., Webster, G.D.  The treatment of 
    urethral obstruction, Journal of Urology, August 2000.
14. Samimi, Dary, MD.  Burch-Sling, Outpatient, Society for Gynecologic 
    Investigation. Los Angeles, CA  2001.
15. Samimi, Dary, MD.  Outpatient Burch-Sling Procedure:  A Nerve Sparing 
    Method for Correction of Female Urinary Incontinence (AVL 160)
    12 minutes ½” VHS, Catalog number: AVL 160, ACOG, ACM, Los Angeles, CA  2002.
16. Samimi, Dary, MD.  Bloodless Nerve Sparing TAH.  ACOG, ACM, 
    New Orleans, Louisiana.  2003

NOTE: This publication is available on DVD. Video was taken of the entire procedure in the Operating Theater with Dr. Samimi. Please click here for Purchase Information:
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