LAPAROSCOPIC BURCH vs. TENSION-FREE VAGINAL TAPE
MAURICE K. CHUNG, RPh, MD
Urinary incontinence affects more than 25 million American women [1]. Currently, more than 100 different surgical procedures are available for treatment of this disorder. The 2 most common procedures are the pubovaginal sling and retrourethropexies, such as the Marshall-Marchetti-Krantz (MMK) cystourethropexy and the Burch procedure. These techniques have a success rate of over 80%, whether they are open [1] or laparoscopic [2-4]. Obesity increases not only the operative complications but also the postoperative failure rate. Numerous articles [5-10] have been published in regard to obesity as both a cause of stress urinary incontinence and postsurgical failure.
Recently, a surge of mid urethral sling procedures, such as the Sparc, Monarc, Mentor OB tape, and intervaginal slingplasty (IVS) procedure, have been developed to treat this condition, but no long-term follow-up studies have been conducted, and the tape material used has been different. The transvaginal tension-free (TVT) procedure has been performed for about 6 years in North America, and longer than that in Europe. It is a minimally invasive mid urethral sling procedure for treating urodynamic stress urinary incontinence with a success rate averaging over 80% [11-28]. Currently, little long-term data exist concerning the procedure in obese women [29-31]. We studied the effectiveness and complications of the laparoscopic Burch and TVT procedures in the obese female in a private Midwest community hospital setting.
METHODS
We studied 51 consecutive cases of the laparoscopic Burch procedure performed from January 1, 1998 through February 28, 1999. We also studied 91 consecutive cases of the TVT procedure in women, aged 34 to 79, during the 12 months between April 1, 1999 and March 31, 2000. These women had documented urinary stress incontinence and underwent a TVT, either as a separate procedure (44 patients) or combined with another procedure (47 patients).
In the laparoscopic Burch group, 17 patients had the Burch procedure only, and 34 patients had combined procedures. In the TVT group, 41 patients underwent TVT only, and 47 patients had combined procedures.
All patients had a proper preoperative history taken, physical examination performed, as well as laboratory testing. Cystometric and urodynamic procedures were performed in all of these patients to detect detrusor instability and intrinsic sphincter deficiency. Only patients with urodynamic stress incontinence were included in the Burch group. These patients were further divided into 5 groups based on their body mass index. In the Burch group, about 65% of these patients were considered normal or overweight; only 35% of the patients were considered obese. The Obesity I group included 26% of the patients, Obesity II group included 9%, and the Obesity III group had no patients. However, in the TVT group, 33% of patients were normal or overweight. Of the patients, 66% were considered obese and 43% were classified as having Obesity II-III.
ANESTHESIA
In the Burch group, all patients required general anesthesia. Whereas, in the TVT group the surgeries were performed with the patient under either general anesthesia, spinal anesthesia, epidural anesthesia, or local anesthesia with IV sedation. In all cases, a local anesthetic mixture of 30 cc Lidocaine 1% with epinephrine (1 to 100 000 dilution), 30 cc of Marcaine 1/2% with epinephrine (1 to 100 000 dilution), and 60 cc of saline were used to form a 1/4% dilution of the anesthetic solution. This was used for hydrodistention, hemostasis, and postoperative analgesia.
OPERATION
All Burch procedures were performed with the laparoscopic intraperitoneal approach, as this enabled us to evaluate the peritoneal cavity and treat all possible pelvic organ defects. In general, it required over 1 hour of operative time and was performed the same way as the classical Burch colposuspension. We utilized nonabsorbable O Gore-Tex, Prolene, or Ethibond sutures. We sutured the periurethral endopelvic pubocervical fascia to the Coopers ligament in a figure 8 fashion.
TVT procedures were performed according to the recommended directions from Gynecare [32]. The operative time related to the TVT portion of the surgery ranged from 18 to 40 minutes. In combined procedures, the TVT was always performed last. The tape was set, as the patients were waking up from the general anesthesia or when they were able to generate a good cough response or Valsalva during regional or local anesthesia.
RESULTS
All patients had follow-up visits in the office every 3 to 4 months for the first year, every 6 months for the second year, and then yearly. In addition, to answering a questionnaire regarding their urinary leakage during the office visits, they were all tested using a cough stress test with a full bladder.
At 48 to 60 months after surgery, in the laparoscopic Burch group, 12 patients (23.5%) were lost to
follow-up, 30 (76.9%) remained dry, 16 (41%) had symptoms of overactive bladder, and 9 (23%) had minimal mixed incontinence, but their symptoms were better than they had been before the surgery. Complications were minor and were treated intraoperatively [29]. The average length of stay for those undergoing the Burch procedure was 1.1 days. The urinary catheters were removed by the first postoperative appointment the week following the surgery.
In the TVT group, no bladder, bowel, or vascular injuries have occurred related to the TVT procedure. Superficial suprapubic ecchymosis occurred occasionally, but these minor complications have not required further intervention.
The length of stay was less than 1 day. Fifty percent of patients were discharged without an indwelling Foley catheter. The patients were seen in the office 1 week following the procedure, by which time 81 patients (90%) were free of urinary catheters. All patients remaining with urinary retention longer than 1 week had undergone combined procedures.
At 48- to 60-month follow-up, in the TVT group, 9 patients (9.8%) were lost to follow-up, 74 (90.2%) were completely dry, and 25 (30.5%) had symptoms of overactive bladder in which 6 (7.3%) had mild urgency incontinence. Four patients (5.4%) had some voiding dysfunction. Two patients required TVT released due to urinary retention and voiding difficulty.
CONCLUSION
Laparoscopic Burch colposuspension is an excellent minimally invasive procedure. It enables us to treat genuine stress urinary incontinence with a very good success rate [2-4]. In addition, it allows us to correct the coexisting pelvic organ relaxation and treat existing pelvic disease. We performed over 150 laparoscopic Burch procedures before the availability of the new TVT technology. We chose the most recent 51 cases because of the availability of office cystometric/urodynamic testing and standardization. The laparoscopic Burch approach requires general anesthesia, a longer operative time, advanced endoscopic surgical suturing skill, and is technically very difficult in obese patients. We offered the procedure mostly to the normal through the Obesity I group (65%) because we feared operative failure due to the obesity as shown in previous literature.5,8-10 As soon as the TVT became available in March 1999, all patients were treated with it.
Forty-three percent of our TVT patients were morbidly or massively obese (Obesity II and III); whereas, the laparoscopic Burch group had only 9 patients in the Obesity II group and no massively obese patients. These patients are often avoided by even skilled surgeons because of concern about technical difficulties, surgical complications, and postoperative failures.
Traditional open retropubic urethropexies are even more difficult with massively obese patients and carry a high failure rate and more trauma to the patients [5,8-10]. The pubovaginal sling procedure can be performed to correct stress urinary incontinence in obese patients, but skilled surgeons may still be reluctant to offer the choice due to the patient’s body habitus [5,8-10].
The initial success rate of the laparoscopic Burch procedure at 12- to 24-month follow-up was 90% and was favorable when compared with that of TVT [29]. However, with the test of time, the effectiveness in controlling urodynamic stress incontinence decreased and only 76.9% of the Burch group remained dry. At 48- to 60-month follow-up, in the TVT group, 90.2% were completely dry. This study demonstrates that the TVT procedure can stand the test of time, and its effectiveness over time will remain excellent.
Therefore, our study indicates that TVT is a safer, easier, and more effective surgery for obese patients with urodynamic stress urinary incontinence and intrinsic (urethral) sphincter deficiency. It is very important to select the appropriate surgical continent procedures for the different groups of patients to achieve the best results [33]. The TVT procedure appears to improve many women’s symptoms of urgency and frequency [29].
Address reprint requests to: Maurice K. Chung, RPh, MD, Midwest Regional Center for Chronic Pelvic Pain and Bladder Control, Alliance for Women’s Health, 310 S Cable Rd, Lima, OH 45805, USA. Tel: 419 228 1000, Fax: 419 227 3085, E-mail: Endosurgeon85@aol.com
Maurice K. Chung, RPh, MD, is a graduate of Northeastern University College of Pharmacy, Boston, Massachusetts. He received his medical training from Tufts University School of Medicine, Boston, and postgraduate Ob/Gyn residency training at Albany Medical Center, New York. He is a Fellow of the American College of Obstetricians and Gynecologists and received certification from the Accreditation Council of Gynecologic Endoscopy in 1996 as one of the thousand certified Advanced Laparoscopists and Hysteroscopists in the United States.
Dr Chung is a Clinical Assistant Professor at the Medical College of Toledo, Ohio; Adjunct Professor of Pharmacy at Ohio Northern University, Ada, Ohio; Director of the Midwest Regional Center for Chronic Pelvic Pain and Bladder Control in Lima, Ohio; and has a private practice in Lima, Ohio. His focus interests in the last 12 years have been in advanced laparoendoscopic surgery, minimally invasive surgery, urogynecology and treatment of chronic pelvic pain, interstitial cystitis, and endometriosis. He has published clinical papers and has presented at national and international meetings, is a board member of the International Society for Gynecologic Endoscopy, and a national advisory board member of the Society of Laparoendoscopic Surgeons. Dr Chung organized the first urogynecology conference in Shanghai, China in 2000 and performed the first TVT in China.
References
1. Walters M, Karram M. Urology and Reconstructive Pelvic Surgery. 2nd ed. St Louis, MO: Mosby. 1999.
2. Ross JW. Laparoscopic colposuspension: 5-year outcome. Int J Urogynecol. 1999;10(suppl 2):S14-S28.
3. Marossian H, Walters MD, Weber AM, Piedmonte MR. Clinical outcomes of laparoscopic and open Burch procedures. Int J Urogynecol. 1999;10(suppl 2):41-34.
4. Bajzak KI, Winer WK, Lyons TL. Five-year follow-up of laparoscopic Burch procedure. J Am Assoc Gynecol Laparosc. 1999;6(suppl 3):S4-S14.
5. Ramirez EM, de la Cruz IS, Gonzalez ML, Florian AC, Banuet VG. Obesity as a risk factor in surgery for urinary incontinence. Obstet Mex. 1997;65:458-460.
6. Cummings JM, Rodning CB. Urinary stress incontinence among obese women: review of pathophysiology therapy. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(1):41-44.
7. Sustersic O, Kralj B. Influence of obesity, constitution and physical work on the phenomenon of urinary incontience in women. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9(3):140-144.
8. Cummings JM, Boullier JA, Parra RO. Surgical correction of stress incontinence in morbidly obese women. J Urol. 1998;160(3 pt1):754-755.
9. Clemens JQ, Stern JA, Bushman WA, Schaeffer AJ. Long-term results of the Stamey bladder neck suspension: direct comparison with the Marchall-Marchette-Krantz procedure. J Urol. 1998;160(2):372-376.
10. Hoang-Bohm J, Junemann KP, Krautschick A, Braun PM, Marx C, Alken P. Burch vs Stamey comparison. Long-term outcome of 2 competing surgical methods. Urologe A. 1997;36(5):400-404.
11. Halaska M, Otcenasak M, Havel R, et al. Suspension of the lower third of the urethra in ambulatory practice–minimally invasive treatment of urinary stress incontinence–technique and initial experience [in Czech]. Ceska Gynekol. 2000;65(1):4-9.
12. Jimenez CJ, Hualde AA, Gonzalez de Garigay SA, et al. Arch Esp Urol. 2000;53:9-13.
13. Klutke JJ, Carlin BI, Klutke CG. The TVT procedure: correction of stress incontinence with minimum alteration in proximal urethral mobility. Urology. 2000;55(4):512-514.
14. Moore RD, Speights S, Miklos JR. Surgical treatment of stress urinary incontinence and severe pelvic organ relaxation in the medically compromised elderly patient using local anesthesia [abstract]. Obstet Gynecol. 2000;95(suppl 1)4:S56.
15. Hardart A, Klutke JJ, Klutke CG, Carlin B. Altered voiding after the TVT procedure: is increased resistance the mechanism of therapy? [abstract]. Obstet Gynecol. 2000;95(suppl 1)4:S55.
16. Olsson I, Kroon U. A 3 year post operative evaluation of tension-free vaginal tape. Gynecol Obstet Invest. 1999;48(4):267-269.
17. Primicerio M, De Matteis G, Montanino Oliva M, et al. Use of the tension-free vaginal tape in the treatment of female urinary stress incontinence using the TVT. Ginecol. 1999;51(9):355-358.
18. Fernandez IL, Gervaise A, De Tayrac R. Surgical treatment of female urinary stress incontinence using the tension free vaginal tape. J Am Assoc Gynecol Laparosc. 1999;6(suppl 3):S16-S54.
19. Ulmsten U, Petros P. Intravaginal Slingplasty (IVS): an ambulatory surgical procedure for the treatment of female urinary incontinence. Scand J Urol Nephrol. 1995;29:75-82.
20. Ulmsten U, Henriksson L, Johnson PL, Varhos G. TVT surgery. Inter Urogynecol J Pelvic Floor Dysfunct. 1996;7:81-86.
21. Falconer C, Ekman-Ordeberg G , Malmstrom A, Ulsten U. TVT surgery. Inter Urogynecol J Pelvic Floor Dysfunct. 1996;7:133-137.
22. Kohli N, Goldwasser S, Lucente V, et al. Tension free vaginal tape (TVT) for the treatment of stress urinary incontinence. The initial North American experience. Int J Urogynecol. 1999;10:S60-S71.
23. Jacquetin B. Use of “TVT” in surgery for female urinary incontinence. J Gynecol Obstet Biol Reprod (Paris) [in French]. 2000;29(3):242-247.
24. Ulmsten U, Falconer C, Johnson P, Jomaa M, Lanner L, Nilsson CG, Olssen I. A multi-center study of tension free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9(4):210-213.
25. Nilsson CO. The tension free vaginal tape (TVT) for treatment of female urinary incontinence. A minimally invasive surgical procedure. Acta Obstet Gynecol Scand. 1998;suppl 168:34-37.
26. Migliari R, De Angelis M. Tension free vaginal mesh repair for anterior vaginal wall prolapse. Eur Urol. 2000;38(2):151-155.
27. Nilsson CG, Rezapour M, Falconer C. 7 year follow-up of the Gynecare TVT procedure. J Intern Urogynecol Assoc. Annual Meeting Abstract Summary, October, 2003.
28. Jomaa M. A seven year follow-up of Gynecare TVT for surgical treatment of female stress urinary incontinence under local anaesthesia. J Intern Urogynecol Assoc. Annual Meeting Abstract Summary, October, 2003.
29. Chung MK, Chung RP. Comparison of laparoscopic Burch and TVT procedures for treatment of stress urinary incontinence in obese women. JSLS. 2002;6:17-21.
30. Mukherjee K, Constantine G. Urinary stress incontinence in obese women: tension-free vaginal tape is the answer. BJU Int. 2001;88(9):881-883.
31. Rafii A, Darai E, Haab F, Samain E, Levardon M, Deval B. Body mass index and outcome of tension-free vaginal tape. Eur Urol. 2003;43(3):288-292.
32. Gynecare, a Division of Ethicon Inc, a Johnson & Johnson company. Guideline manual for TVT tension free vaginal tape professional education program. New Brunswick, NJ: Johnson & Johnson; 1998.
33. Bergman A. Gynecology Urology Yearbook of Obstetrics, Gynecology and Women’s Health. St. Louis, MO: Mosby; 1997:257-259.
www.Laparoscopy.org The Laparoscopic Surgery Information Source
