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Comparison of laparoscopic and open retropubic urethropexy for treatment of stress urinary incontinence
COMPARISON OF LAPAROSCOPIC AND OPEN RETROPUBIC URETHROPEXY FOR TREATMENT OF STRESS URINARY INCONTINENCE THOMAS J. POLASCIK, M.D. ROBERT G. MOORE, M.D. MATTHEW T. ROSENBERG, M.D. LOUIS R. KAVOUSSI. M.D. From the Brady Urological Institute, The Johns Hopkins Medical Institutions, Baltimore, Maryland, and the Division of Urology Harvard Program in Urology (Longwood area), Brigham and Women’s Hospital, Boston, Massachusetts
ABSTRACT-Objectives. Laparoscopic retropubic urethropexy has recently been described as an alternative method to the surgical correction of pure stress urinary incontinence. This study compares the operative technique and results of laparoscopic colposuspension with traditional open Burch urethropexy to treat women with stress urinary incontinence. Methods. We assessed the short-term results of 12 women who underwent a modified laparoscopic Burch urethropexy for the correction of stress urinary incontinence and compared these with a similar contemporary group of 10 women who underwent a traditional open Burch colposuspension procedure. Results. Ten women (83%) who underwent the laparoscopic procedure are continent with a mean follow-up of 20.8 months, and 7 women (70%) who had an open Burch colposuspension are continent at a mean follow-up of 35.6 months. The laparoscopic procedure took an average of 1.5 hours longer than the open repair [f < 0.011. Patients who underwent the laparoscopic urethropexy required less postoperative analgesia (mean, 14.2 mg morphine equivalents versus 13 1.4 mg; P < 0.0 1). shorter length of hospitalization (mean, 1.9 days versus 4.9 days; P c O.Ol), and a more expedient return to normal activity when compared with those who underwent open Burch colposuspension. Conclusions. Laparoscopic bladder neck suspension offers a less invasive approach to the surgical correction of stress urinary incontinence and can provide successful outcomes in properly selected patients.
Since the introduction of the retropubic urethral suspension by Goebell, Stroekl, and Frangenheim in 1910, various alternative techniques to correct surgically stress urinary incontinence (SUI) have been described.l These procedures include modifications of the open retropubic urethropexy, vaginal anterior colporrhaphy, and transThe vaginal needle suspension techniques. Marshall-Marchetti-Krantz (MMK) and the Burch procedures are two traditional approaches that Submitted:
August
1, 1994,
accepted
(with
rwisions);
14,1994
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/ APR~J
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4
October
have had long-term success rates in restoring continence in approximately 80% of patients.2-5 However, gaining access to the retropubic proximal urethra involves a large incision that can result in significant postoperative morbidity. The evolution of the surgical approach for the correction of SUI has focused on devising a minimally invasive technique to place the proximal urethra in a high, well-supported retropubic position. In an effort to reduce the morbidity associated with the open retropubic urethropexy, Pereyra6 and subsequently others developed the transvaginal approach to bladder neck suspension. 647
Laparoscopy has evolved as an alternative technique that permits placement of suspension sutures under direct vision while avoiding the morbidity associated with the open retropubic repair. Vancaillie and Schuessler7 first described the laparoscopic approach for the correction of SUI using a modified MMK technique. Herein, we report a technique using a laparoscopic modification of the Burch procedure. We retrospectively compare these to a contemporary group of patients undergoing traditional open retropubic urethropexy to assess the success and relative morbidity of these procedures. MATERIAL
AND
METHODS
Between April 1992 and January 1994, 12 women were prospectively selected to undergo a laparoscopic Burch urethropexy after presenting with SUI. Nine transperitoneal and three extraperitoneal laparoscopic Burch urethropexy procedures were performed by one surgeon (L.R.K.). Two women underwent concomitant posterior colporrhaphy. (Because of the additional procedure, these patients are excluded from data analyzing length of hospitalization, narcotic requirements, and change in hematocrit values, but are included in data comprising operative time, estimated blood loss, surgical results, and complications.) The laparoscopic group was retrospectively compared with a similar contemporary group of 10 women who underwent an open Burch urethropexy repair at The Johns Hopkins Hospital between February 1990 and January 1994. Of the 10 cases in the open group, 5 (50%) were done by a single surgeon and the other 5 cases were done by three other surgeons. Both groups were similar in age, race, parity, method of obstetric delivery, American Society of Anesthesiologists (ASA) risk category, previous abdominal operations and surgical repairs for SUI. All women entered into the study were preoperatively confirmed to have genuine SUI. Evaluation of all women included a thorough history, physical examination, cystourethroscopy, and urinalysis. SUI was defined as the involuntary loss of urine through the urethra, attributable to a sudden increase in intra-abdominal pressure. Physical examination consisted of a bimanual pelvic examination and a focused neurologic examination. Evaluations defined the type of incontinence, the presence and degree of cystocele, and any other associated pelvic floor abnormality, including rectocele, enterocele, or uterine hypermobility. Patients demonstrating uterine prolapse, enterocele, or intrinsic sphincter dysfunction were
648
excluded from the laparoscopic repair. SUI was confirmed by leakage of urine in both the supine and erect positions, and the correction of such with a Marshall-Marchetti maneuver.s Pharmacologic agents affecting detrusor and sphincteric tone were discontinued prior to urodynamic assessment. All candidates then underwent cystometric evaluation and were found to have a satisfactory storage capacity with pure SUI. There was no evidence of detrusor instability, primary urge incontinence, or significant postvoid residual volume, although 1 woman in the laparoscopic group historically had associated urgency Intrinsic sphincter dysfunction was determined by cystoscopic appearance of the sphincter and by urodynamics. Two patients in the open group had a grade I cystocele by pelvic examination and another had a grade II cystocele. Two women in the laparoscopic group had a grade I cystocele. Information regarding the patients having had the open surgical repair was obtained by reviewing consecutive medical records on all patients undergoing the Burch procedure at The Johns Hopkins Hospital between February 1990 and January 1994. Exclusion criteria for this group included concomitant anterior colporrhaphy or other surgical procedures (such as an exploratory laparotomy, abdominoplasty, or hysterectomy), regional anesthesia, ASA class IV, and incontinence other than pure anatomic SUI. Regional anesthesia was excluded to control for differences in mode of anesthetic delivery when evaluating for postoperative analgesic consumption and return to activity Information regarding operative time, intraoperative blood loss, intraoperative fluid requirements, preoperative and postoperative hematocrit, postoperative analgesic requirements, length of hospitalization, and complications were obtained for both groups. In addition to routine clinic appointments, all patients in both the laparoscopic and the open surgical groups were contacted postoperatively by telephone in May 1994. All patients in the laparoscopic group were recontacted in September 1994 for additional follow-up, partly to compensate for lead-time bias in the historical control group. Queries were standardized and directed at the time elapsed before return to normal activity, posthospital analgesic requirements, and current characterization of continence in relation to activity level. All analgesics taken postoperatively were converted to parenteral morphine equivalents.9 Statistical analysis was performed using the Wilcoxon ranked sum test with P ~0.05 regarded as statistically significant.
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TABLE I.
Patient
Laparoscopic 12 51 92 8
No. Mean age (y) ASA class I and II (%) ASA class Ill (%) Prior transabdominal surgery (%) Prior urethropexy (%) KEY: NS = not statistically
demographics
67 8
Open 10 55 70 30
P Value
70 10
NS NS
NS NS
significant.
PATIENTDEMOGRAPHICS
Twelve women, ages 42 to 67 (mean, 51.3) years constituted the group undergoing a laparoscopic Burch urethropexy (Table I). Eight patients (67%) underwent prior abdominal procedures, including 3 patients who had a total abdominal hysterectomy. Two women underwent a previous vaginal hysterectomy and Kelly plication procedure. One patient had undergone a previous Stamey urethropexy. Ninety-two percent in this group were classified as ASA class I or II and 8% were regarded as ASA class III. Ten women (83%) had at least two prior pregnancies each, with all deliveries occurring per vagina. Two women were nulliparous. Ten women ages 41 to 74 (mean, 55.1) years constituted the contemporary group undergoing an open Burch procedure. Seven patients underwent at least one other abdominal procedure, including 4 patients who had a prior total abdominal hysterectomy Three patients had a previous vaginal hysterectomy and 1 woman had a previous bladder neck suspension procedure. Seven patients were preoperatively classified as ASA class II and the remainder were ASA class III. Nine of the women had prior pregnancies, with 8 patients having had at least 2 children. All pregnancies were delivered vaginally except in 2 women, each of whom had had one prior cesarean section. Both groups of women were well-matched, and differences regarding age, parity, ASA category, previous urethropexy, and prior transabdominal surgery, including total abdominal hysterectomy, did not reach statistical significance. OPERATIVE
TECHNIQUE
LAPAROSCOPIC APPROACH
The patient was placed in the supine frog-leg position. A Foley catheter and an orogastric tube were placed to decompress the bladder and stomach, respectively After induction of a general anesthesia, a pneumoperitoneum was obtained in standard fashion with a Veress needle. A lo- or 12-mm trocar was placed in the inferior umbilical crease.
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A second lo- or 12-mm trocar was then placed at the level of the umbilicus in the left upper quadrant, lateral to the rectus muscle. Two S-mm trocars were placed, one in each lower quadrant 5 cm below the level of the umbilicus. The dissection was initiated by incising the peritoneum over the pubic bone medial to the umbilical ligaments. The posterior aspect of the pubic bone, periurethral fascia, and anterior vaginal wall was exposed. Filling the bladder with 150 cc of saline aided in this dissection. A 2-O Ticron suture (Davis and Geck, Manati, Puerto Rico) was passed through the left upper lateral port and placed in the periurethral fascia just lateral to the urethra. Suture placement was aided by digital displacement of the vaginal wall anteriorly. The needle was then placed through Coopers ligament. The bladder neck was elevated under direct vision by pulling up on the suture. The suture was secured with a Lapra-Ty suture crimper (Ethicon, Cincinnati, Ohio). This maneuver was then repeated on the contralateral side. A proximal suture was then placed on the left and right sides of the urethra and fixed to Coopers ligament. The peritoneum was closed with a hernia stapler and the procedure concluded in standard fashion. Neither drains nor suprapubic tubes were used. An extraperitoneal approach was utilized in 3 patients. The space of Retzius was insufflated with a Veress needle 1 cm away from the midline and 1 cm above the pubic ramus. A tense pneumoretroperitoneum was obtained. An umbilical lo- or 12-mm trocar was then placed. A balloon catheter (Preperitoneal Distention Balloon System, Origin Inc., Menlo Park, Calif) was introduced into this preperitoneal space and filled with 800 cc of saline. Blunt dissection was used to create additional lateral space for secondary trocars. The remainder of the procedure was carried out as per the transabdominal approach. OPENAPPROACH
The space of Retzius was approached via a Pfannenstiel incision. After this space was developed bluntly, Cooper’s ligament and the lateral vaginal wall near the bladder neck were exposed. A urethral catheter was placed to aid in manually identifying the urethra and the bladder neck. Two sutures (silk, polyglactin, or Prolene were used at the surgeon’s discretion) on both the right and left sides of the urethra were placed between the lateral vaginal wall and Cooper’s ligament. A prevesical drain was placed in all cases and a suprapubic tube was used in 5 patients. The wound was then closed in standard fashion.
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TABLE II.
Operative
Mean operative time (min) Mean blood loss (cc) Mean change in hematocrit [%)* Hospital stay (days) * Parenteral analgesia (mg morphine) * + Follow-up (mo) Postoperative continence (%)
and postoperative Laparoscopic 190 (1 1O-255) 108 (20-300) 1.2 1.9 (l-4) 14.2 (O-80) 20.8 (8-29) 83
data
Open 109 [33- 150) 153 (50-400) 6.6 4.9 (4-6) 13 1.4 (70-296) 35.6 (1 l-50) 70
P Value co.01 NS co.01 co.01 < 0.0 1 < 0.05 NS
KEY: NS=notstatistically sign&ant. *Excludes 2patients inthelaparoscopic group undergoing concomitant rectocele repair. ‘Parenteral morphine equivalents.
RESULTS LAPAROSCOPIC GROUP
Operative time in the laparoscopic group ranged from 110 to 240 minutes (mean, 185) for the transperitoneal approach and 115 to 255 minutes (mean, 199) for the extraperitoneal technique. Estimated mean blood loss for either approach was 108 cc, mean intraoperative fluid requirements were 1855 mL of crystalloid, and mean change in hematocrit was 1.2% (Table II). Length of hospitalization ranged from 1 to 4 days (mean, 1.9). Narcotic requirements while in hospital averaged 14.2 mg (range, 0 to 80) of morphine equivalents. Following discharge, 11 patients denied consuming oral narcotics and 1 woman required 50 mg of oxycodone. Patients’ subjective response to the amount of convalescent time needed prior to returning to their normal level of activity ranged from 2 to 30 days (mean, 7.8). Perioperative complications include 2 patients sustaining a bladder perforation that was recognized and repaired laparoscopically during the procedure. Postoperatively, 3 patients developed urinary retention and were discharged with a urethral catheter. One of these women required an indwelling catheter for 1 month. However, all cases of postoperative urinary retention subsequently resolved and these women are currently continent. Another patient developed an Enterococcus wound infection of the umbilical port that resolved with oral antibiotics and wound care. No patient required a perioperative blood transfusion. All 12 women were contacted in September 1994 with a mean follow-up of 20.8 months (range, 8 to 29). Ten women (83%) are completely continent and 2 (17%) have mild SUI without urgency Three women (25%) who are fully continent also have occasional urgency. One of these women had SUI with associated urgency preoperatively. One failure was a 67-year-old nulliparous woman who underwent a transabdominal approach. She
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was completely continent 14 months after surgery, but by 24 months she required 1 or 2 sanitary napkins per day for control of incontinence. The second failure was a 48-year-old gravida IV, para II woman who had a prior Stamey procedure in 1979. She underwent a transabdominal approach, sustaining a bladder perforation that was repaired intraoperatively She was completely continent at 12 months following surgery except for occasional urgency, but by 24 months’ follow-up was requiring 1 or 2 sanitary pads per day for control of incontinence. There were no additional risk factors that would identify a reason for failure in either patient. OPENGROUP
Ten Burch procedures were performed through a standard Pfannenstiel incision. Operative time ranged from 33 to 150 minutes (mean, 109). Blood loss ranged from 50 to 400 cc (mean, 153), with an average of 2080 cc of lactate solution administered intraoperatively (Table II). The mean change in hematocrit was 6.6%. Postoperative length of hospitalization ranged from 4 to 6 days (mean, 4.9). Narcotic requirements in the hospital averaged 131.4 mg (range, 70 to 296 mg) of morphine equivalents. Following discharge, 7 women subjectively rated their pain and oral narcotic use as “minimal,” 2 as “moderately severe,” and 1 could not precisely recall. Patients’ subjective response to the amount of convalescent time needed prior to returning to their normal level of activity ranged from 1 to 52 weeks (mean, 11). Complications include 2 patients who developed postoperative urinary retention and required an indwelling catheter for 2 and 5 weeks. One transient case of congestive heart failure occurred postoperatively and was successfully managed with diuretics. Two patients developed a urinary tract infection and another had a wound infection that resolved without sequela. No patient required a perioperative blood transfusion. U ROLOCYQ /APRIL1995I VOLUME 45,NUMBER 4
Seven patients (70%) were completely continent at a mean of 35.6 months’ (range, 11 to 50) follow-up. Three patients had evidence of SUI postoperatively Two of these women also had de novo urgency and required 1 to 2 sanitary pads per day, and the third patient did not experience urgency and required 3 to 5 sanitary pads per day for control of incontinence. Nonparametric comparison of medians using the Wilcoxon ranked sum test demonstrated statistical significance between the two groups of patients regarding length of hospitalization, postoperative analgesia requirements, return to normal activity, and mean operative time. Postoperative urgency and continence between the two groups were not statistically significant. COMMENT The Burch procedure, described in 1961, suspends the proximal urethra in a high retropubic position by securing perivaginal fascia and anterior vaginal wall to Cooper’s ligament. Advantages of this approach include simultaneous correction of mild cystocele, strong periosteal support, and lateral placement of suspension sutures, thereby avoiding urethral obstruction.1° With the Burch procedure, the sutures are placed more laterally than the MMK technique, minimizing the potential of urethral obstruction and osteitis pubis.ll The Burch colposuspension successfully restores continence in 84% to 94% within 1 to 2 years in most large series. 5~12~13This technique compares favorably with the various other surgical options, including needle suspensions, anterior colporrhaphy, and other open approaches such as the MMK and the Richardson paravaginal repair.5 Our laparoscopic continence rates are comparable to both open and other laparoscopic series. Albala and associates14 reported on 22 laparoscopic MMK procedures performed on women with grade I or II SUI. Results revealed all patients continent at 9.5 months. Liu and Paek15 performed 107 laparoscopic Burch procedures for an overall success rate of 97.2%, with follow-up ranging from 3 to 27 months. Of note, 87 of the 107 patients in this series underwent concomitant major laparoscopic procedures, including hysterectomy and salpingo-oophorectomy, and all 107 patients had a concomitant Moschcowitz procedure to obliterate the cul-de-sac. McDougall and associates16 reported a 80% success rate with 17 women who underwent either a modified laparoscopic MMK, Burch, or Richardson procedure. The interpretation of all of these results should be viewed with caution as the mean follow-up re-
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ported was short. Early resolution of SUI following surgical procedures does not guarantee longterm cure.5 We believe the 83% continence rate attained in our series with the laparoscopic Burch urethropexy is equivalent to the 70% continence rate following the open Burch repair (difference not significant). The colposuspension technique used in both the open and the laparoscopic groups was anatomically the same, as such the continence rates should be similar irrespective of the approach. Variability in outcome in this study is due to a relatively small number of patients in each group and differences in length of follow-up (mean: open, 35 months versus laparoscopic, 20.8 months). There are scant data in the literature documenting when during the postsurgical period failures of anti-incontinence surgery become apparent. In a review of the literature, Spencer and O’Conor5 determined that failures occurred anywhere between 6 months and 23 years postoperatively They concluded that accurate cure rates could best be determined with a minimum of 5 years of follow-up.5 Although operative time is longer, the laparoscopic approach appears to offer several benefits compared with traditional open retropubic suspensions. The advantages of the laparoscopic approach are reflected in a shorter length of hospitalization, reduced narcotic requirements, and a more expedient return to activity (Table II). These benefits have also been observed with other laparoscopic urologic procedures.17,18 Inadvertent bladder injury has been the most common intraoperative complication, resulting in prolonged operative time. Liu and Paek15 reported four such injuries in 107 patients, while Albala et a1.,14 Harewood,19 and McDougall et a1.16 each reported one bladder injury in each series. These injuries occurred early in all series. Typically, the vesical rent occurs at the dome of the bladder while initially gaining access to the space of Retzius using the transperitoneal approach. Fortunately, these injuries can usually be recognized intraoperatively and suture or stapled repairs have been successful. To avoid this injury, care must be taken in dissection, and the bladder wall should be identified. Bladder injury can also be avoided by filling the bladder with 150 cc of saline to delineate its boundaries during dissection. Iaparoscopic retropubic urethropexy affords excellent vision within the space of Retzius and allows for easy mobilization of periurethral tissue and placement of suspension sutures. Patients having
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had prior urethropexies can be approached laparoscopically. Previous abdominal procedures including total abdominal hysterectomy did not interfere with a successful outcome. In addition, bleeding from the anterior vaginal wall with suture placement was not observed in the laparoscopic group. We believe this is secondary to the intra-abdominal pressure created by the pneumoperitoneum. For women with prior lower abdominal surgery, an extraperitoneal approach is preferable. Although our experience with the extraperitoneal technique is limited to 3 patients, this approach did not prove to be more technically difficult than the transperitoneal approach, as operative time and blood loss were similar. Postoperatively, there was no difference in hospital stay or return to normal activity when compared with the transperitoneal approach. Ongoing series comparing transperitoneal and extraperitoneal laparoscopy should delineate the risks and benefits associated with each approach. Although this is not a prospective, randomized study, our data compare contemporary patients undergoing open and laparoscopic Burch colposuspension performed at one institution. Our data imply that the laparoscopic approach provides equivalent success with much less morbidity when compared with traditional open retropubic suspensions. McDougall and associates16 recently compared laparoscopic urethropexy to Raz urethropexy and found both procedures to be equally successful. The only 2 failures that occurred in 9 patients undergoing laparoscopic repair with follow-up of at least 1 year had undergone a modified laparoscopic MMK suspension. They concluded that the modified laparoscopic Burch or Richardson repair appeared to be more successful. Preliminary data of the small number of women studied suggest that this technique can provide successful outcomes in properly selected patients. Patients with anatomic SUI with or without a small cystocele can be offered a laparoscopic technique. Additional studies involving a larger cohort of women undergoing the laparoscopic Burch urethropexy need to be assessed before adequate conclusions regarding long-term continence can be drawn. Thomas J. Polascik, M.D. The Brady TheJohns
Urological
Institute
Hopkins Bayview Medical Center 4940 Eastern Avenue Baltimore, MD 21224
ACKNOWLEDGMENT. To Dr. Alan Partin for assistance in statistical analysis.
652
REFERENCES 1. Goebell R: Zur operativen beseiligung der angeharenen incontinentia vesicae. A Gynak Urol2: 187, 1910. 2. National Institutes of Health Consensus Development Conference: Urinary incontinence in adults. J Am Geriatr Sot
38: 265-272, 3. Marshall
1990.
VF, Marchetti AA, and Krantz KE: The correction of stress incontinence by simple vesicourethral suspension. Surg Gynecol Obstet 88: 509-518, 1949. 4. Burch JC: Urethrovaginal fixation to Cooper’s ligament for the correction of stress incontinence, cystocele and prolapse. Am J Obstet Gynecol 81: 281-290, 1961. 5. Spencer JR, and O’Conor VJ Jr: Comparison of procedures for stress urinary incontinence. AUA Update Series 6 (no. 28): 1987. 6. Pereyra AJ: A simplified surgical procedure for the correction of stress incontinence in women. West J Surg Obstet Gynecol 67: 223-226, 1959. 7. Vancaillie TG, and Schuessler W: Laparoscopic bladder neck suspension. J Laparoendosc Surg 1: 169-173, 1991. 8. Marchetti AA, Marshall VF, and Shultis LD: Simple vesicourethral suspension. A survey. Am J Obstet Gynecol 74: 57-63, 1957. 9. Acute Pain Management Guideline Panel: Acute Pain Management: Operative or Medical Procedures and Trauma. Clinical Practice Guideline. AHCPR Pub. No. 92-0032. Rockville, Md: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services. Feb 1992, pp 112-113. 10. Raz S, Little NA, and Juma S: Female urology, in Walsh PC, Retik AB, Stamey TA, and Vaughan ED Jr (Eds): Campbell’s Urology, 6th ed, vol 3, Philadelphia, WB Saunders Co, 1992, pp 2782-2828. 11. Zimmern PE, Hadley HR, Leach GE, and Raz S: Female urethral obstruction after Marshall-Marchetti-Krantz operation. J Urol 138: 517-520, 1987. 12. Van Geelen JM, Theeuwes AG, Eskes TK, and Martin CB Jr: The clinical and urodynamic effects of anterior vaginal repair and Burch colposuspension. Am J Obstet Gynecol 159: 137-144, 1988. 13. Stanton SL, Hertogs K, Cox C, Hilton P, and Cardozo L: Colposuspension operation for genuine stress incontinence, a five-year study. Proceedings of the XII annual meeting of the International Continence Society. Leiden: International Continence Society, 1982:94. 14. Albala DM, Schuessler WW, and Vancaillie TG: Laparoscopic bladder neck suspension. J Endourol 6: 137-141, 1992. 15. Liu CY, and Paek W: Laparoscopic retropubic colposuspension (Burch procedure). Gynecol Laparoscop 1: 31-34, 1993. 16. McDougall EM, Klutke CG, Clayman RV, and Cornell T: Comparative analysis of vaginal (Raz) and laparoscopic bladder neck suspension for type I or type II stress urinary incontinence (abstract 1085). J Urol 151: 499A, 1994. 17. Winfield HN, See WA, Donovan JF, Godet A, Farage YM, Loening SA, and Williams RD: Comparative effectiveness and safety of laparoscopic versus open pelvic lymph node dissection for cancer of the prostate (abstract 124). J Urol 147: 244A,1992. 18. Kavoussi LR, Kerbl K, Capelouto CC, McDougal EM, and Clayman RV: Laparoscopic nephrectomy for renal neoplasms. Urology 42: 603-609, 1993. 19. Harewood LM: Laparoscopic needle colposuspension for genuine stress incontinence. J Endourol 7: 319-322, 1993.
UROLOGY@ /APRIL 19951 VOLUME~~,NLJMBER~
ABSTRACT-Objectives. Laparoscopic retropubic urethropexy has recently been described as an alternative method to the surgical correction of pure stress urinary incontinence. This study compares the operative technique and results of laparoscopic colposuspension with traditional open Burch urethropexy to treat women with stress urinary incontinence. Methods. We assessed the short-term results of 12 women who underwent a modified laparoscopic Burch urethropexy for the correction of stress urinary incontinence and compared these with a similar contemporary group of 10 women who underwent a traditional open Burch colposuspension procedure. Results. Ten women (83%) who underwent the laparoscopic procedure are continent with a mean follow-up of 20.8 months, and 7 women (70%) who had an open Burch colposuspension are continent at a mean follow-up of 35.6 months. The laparoscopic procedure took an average of 1.5 hours longer than the open repair [f < 0.011. Patients who underwent the laparoscopic urethropexy required less postoperative analgesia (mean, 14.2 mg morphine equivalents versus 13 1.4 mg; P < 0.0 1). shorter length of hospitalization (mean, 1.9 days versus 4.9 days; P c O.Ol), and a more expedient return to normal activity when compared with those who underwent open Burch colposuspension. Conclusions. Laparoscopic bladder neck suspension offers a less invasive approach to the surgical correction of stress urinary incontinence and can provide successful outcomes in properly selected patients.
Since the introduction of the retropubic urethral suspension by Goebell, Stroekl, and Frangenheim in 1910, various alternative techniques to correct surgically stress urinary incontinence (SUI) have been described.l These procedures include modifications of the open retropubic urethropexy, vaginal anterior colporrhaphy, and transThe vaginal needle suspension techniques. Marshall-Marchetti-Krantz (MMK) and the Burch procedures are two traditional approaches that Submitted:
August
1, 1994,
accepted
(with
rwisions);
14,1994
UROLOGY@
/ APR~J
199.5
I Vor UME 45, NUMBER
4
October
have had long-term success rates in restoring continence in approximately 80% of patients.2-5 However, gaining access to the retropubic proximal urethra involves a large incision that can result in significant postoperative morbidity. The evolution of the surgical approach for the correction of SUI has focused on devising a minimally invasive technique to place the proximal urethra in a high, well-supported retropubic position. In an effort to reduce the morbidity associated with the open retropubic urethropexy, Pereyra6 and subsequently others developed the transvaginal approach to bladder neck suspension. 647
Laparoscopy has evolved as an alternative technique that permits placement of suspension sutures under direct vision while avoiding the morbidity associated with the open retropubic repair. Vancaillie and Schuessler7 first described the laparoscopic approach for the correction of SUI using a modified MMK technique. Herein, we report a technique using a laparoscopic modification of the Burch procedure. We retrospectively compare these to a contemporary group of patients undergoing traditional open retropubic urethropexy to assess the success and relative morbidity of these procedures. MATERIAL
AND
METHODS
Between April 1992 and January 1994, 12 women were prospectively selected to undergo a laparoscopic Burch urethropexy after presenting with SUI. Nine transperitoneal and three extraperitoneal laparoscopic Burch urethropexy procedures were performed by one surgeon (L.R.K.). Two women underwent concomitant posterior colporrhaphy. (Because of the additional procedure, these patients are excluded from data analyzing length of hospitalization, narcotic requirements, and change in hematocrit values, but are included in data comprising operative time, estimated blood loss, surgical results, and complications.) The laparoscopic group was retrospectively compared with a similar contemporary group of 10 women who underwent an open Burch urethropexy repair at The Johns Hopkins Hospital between February 1990 and January 1994. Of the 10 cases in the open group, 5 (50%) were done by a single surgeon and the other 5 cases were done by three other surgeons. Both groups were similar in age, race, parity, method of obstetric delivery, American Society of Anesthesiologists (ASA) risk category, previous abdominal operations and surgical repairs for SUI. All women entered into the study were preoperatively confirmed to have genuine SUI. Evaluation of all women included a thorough history, physical examination, cystourethroscopy, and urinalysis. SUI was defined as the involuntary loss of urine through the urethra, attributable to a sudden increase in intra-abdominal pressure. Physical examination consisted of a bimanual pelvic examination and a focused neurologic examination. Evaluations defined the type of incontinence, the presence and degree of cystocele, and any other associated pelvic floor abnormality, including rectocele, enterocele, or uterine hypermobility. Patients demonstrating uterine prolapse, enterocele, or intrinsic sphincter dysfunction were
648
excluded from the laparoscopic repair. SUI was confirmed by leakage of urine in both the supine and erect positions, and the correction of such with a Marshall-Marchetti maneuver.s Pharmacologic agents affecting detrusor and sphincteric tone were discontinued prior to urodynamic assessment. All candidates then underwent cystometric evaluation and were found to have a satisfactory storage capacity with pure SUI. There was no evidence of detrusor instability, primary urge incontinence, or significant postvoid residual volume, although 1 woman in the laparoscopic group historically had associated urgency Intrinsic sphincter dysfunction was determined by cystoscopic appearance of the sphincter and by urodynamics. Two patients in the open group had a grade I cystocele by pelvic examination and another had a grade II cystocele. Two women in the laparoscopic group had a grade I cystocele. Information regarding the patients having had the open surgical repair was obtained by reviewing consecutive medical records on all patients undergoing the Burch procedure at The Johns Hopkins Hospital between February 1990 and January 1994. Exclusion criteria for this group included concomitant anterior colporrhaphy or other surgical procedures (such as an exploratory laparotomy, abdominoplasty, or hysterectomy), regional anesthesia, ASA class IV, and incontinence other than pure anatomic SUI. Regional anesthesia was excluded to control for differences in mode of anesthetic delivery when evaluating for postoperative analgesic consumption and return to activity Information regarding operative time, intraoperative blood loss, intraoperative fluid requirements, preoperative and postoperative hematocrit, postoperative analgesic requirements, length of hospitalization, and complications were obtained for both groups. In addition to routine clinic appointments, all patients in both the laparoscopic and the open surgical groups were contacted postoperatively by telephone in May 1994. All patients in the laparoscopic group were recontacted in September 1994 for additional follow-up, partly to compensate for lead-time bias in the historical control group. Queries were standardized and directed at the time elapsed before return to normal activity, posthospital analgesic requirements, and current characterization of continence in relation to activity level. All analgesics taken postoperatively were converted to parenteral morphine equivalents.9 Statistical analysis was performed using the Wilcoxon ranked sum test with P ~0.05 regarded as statistically significant.
U ROLOGP
/ APRIL
1995
/ VOLL’M
45, NNIBER
4
TABLE I.
Patient
Laparoscopic 12 51 92 8
No. Mean age (y) ASA class I and II (%) ASA class Ill (%) Prior transabdominal surgery (%) Prior urethropexy (%) KEY: NS = not statistically
demographics
67 8
Open 10 55 70 30
P Value
70 10
NS NS
NS NS
significant.
PATIENTDEMOGRAPHICS
Twelve women, ages 42 to 67 (mean, 51.3) years constituted the group undergoing a laparoscopic Burch urethropexy (Table I). Eight patients (67%) underwent prior abdominal procedures, including 3 patients who had a total abdominal hysterectomy. Two women underwent a previous vaginal hysterectomy and Kelly plication procedure. One patient had undergone a previous Stamey urethropexy. Ninety-two percent in this group were classified as ASA class I or II and 8% were regarded as ASA class III. Ten women (83%) had at least two prior pregnancies each, with all deliveries occurring per vagina. Two women were nulliparous. Ten women ages 41 to 74 (mean, 55.1) years constituted the contemporary group undergoing an open Burch procedure. Seven patients underwent at least one other abdominal procedure, including 4 patients who had a prior total abdominal hysterectomy Three patients had a previous vaginal hysterectomy and 1 woman had a previous bladder neck suspension procedure. Seven patients were preoperatively classified as ASA class II and the remainder were ASA class III. Nine of the women had prior pregnancies, with 8 patients having had at least 2 children. All pregnancies were delivered vaginally except in 2 women, each of whom had had one prior cesarean section. Both groups of women were well-matched, and differences regarding age, parity, ASA category, previous urethropexy, and prior transabdominal surgery, including total abdominal hysterectomy, did not reach statistical significance. OPERATIVE
TECHNIQUE
LAPAROSCOPIC APPROACH
The patient was placed in the supine frog-leg position. A Foley catheter and an orogastric tube were placed to decompress the bladder and stomach, respectively After induction of a general anesthesia, a pneumoperitoneum was obtained in standard fashion with a Veress needle. A lo- or 12-mm trocar was placed in the inferior umbilical crease.
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A second lo- or 12-mm trocar was then placed at the level of the umbilicus in the left upper quadrant, lateral to the rectus muscle. Two S-mm trocars were placed, one in each lower quadrant 5 cm below the level of the umbilicus. The dissection was initiated by incising the peritoneum over the pubic bone medial to the umbilical ligaments. The posterior aspect of the pubic bone, periurethral fascia, and anterior vaginal wall was exposed. Filling the bladder with 150 cc of saline aided in this dissection. A 2-O Ticron suture (Davis and Geck, Manati, Puerto Rico) was passed through the left upper lateral port and placed in the periurethral fascia just lateral to the urethra. Suture placement was aided by digital displacement of the vaginal wall anteriorly. The needle was then placed through Coopers ligament. The bladder neck was elevated under direct vision by pulling up on the suture. The suture was secured with a Lapra-Ty suture crimper (Ethicon, Cincinnati, Ohio). This maneuver was then repeated on the contralateral side. A proximal suture was then placed on the left and right sides of the urethra and fixed to Coopers ligament. The peritoneum was closed with a hernia stapler and the procedure concluded in standard fashion. Neither drains nor suprapubic tubes were used. An extraperitoneal approach was utilized in 3 patients. The space of Retzius was insufflated with a Veress needle 1 cm away from the midline and 1 cm above the pubic ramus. A tense pneumoretroperitoneum was obtained. An umbilical lo- or 12-mm trocar was then placed. A balloon catheter (Preperitoneal Distention Balloon System, Origin Inc., Menlo Park, Calif) was introduced into this preperitoneal space and filled with 800 cc of saline. Blunt dissection was used to create additional lateral space for secondary trocars. The remainder of the procedure was carried out as per the transabdominal approach. OPENAPPROACH
The space of Retzius was approached via a Pfannenstiel incision. After this space was developed bluntly, Cooper’s ligament and the lateral vaginal wall near the bladder neck were exposed. A urethral catheter was placed to aid in manually identifying the urethra and the bladder neck. Two sutures (silk, polyglactin, or Prolene were used at the surgeon’s discretion) on both the right and left sides of the urethra were placed between the lateral vaginal wall and Cooper’s ligament. A prevesical drain was placed in all cases and a suprapubic tube was used in 5 patients. The wound was then closed in standard fashion.
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TABLE II.
Operative
Mean operative time (min) Mean blood loss (cc) Mean change in hematocrit [%)* Hospital stay (days) * Parenteral analgesia (mg morphine) * + Follow-up (mo) Postoperative continence (%)
and postoperative Laparoscopic 190 (1 1O-255) 108 (20-300) 1.2 1.9 (l-4) 14.2 (O-80) 20.8 (8-29) 83
data
Open 109 [33- 150) 153 (50-400) 6.6 4.9 (4-6) 13 1.4 (70-296) 35.6 (1 l-50) 70
P Value co.01 NS co.01 co.01 < 0.0 1 < 0.05 NS
KEY: NS=notstatistically sign&ant. *Excludes 2patients inthelaparoscopic group undergoing concomitant rectocele repair. ‘Parenteral morphine equivalents.
RESULTS LAPAROSCOPIC GROUP
Operative time in the laparoscopic group ranged from 110 to 240 minutes (mean, 185) for the transperitoneal approach and 115 to 255 minutes (mean, 199) for the extraperitoneal technique. Estimated mean blood loss for either approach was 108 cc, mean intraoperative fluid requirements were 1855 mL of crystalloid, and mean change in hematocrit was 1.2% (Table II). Length of hospitalization ranged from 1 to 4 days (mean, 1.9). Narcotic requirements while in hospital averaged 14.2 mg (range, 0 to 80) of morphine equivalents. Following discharge, 11 patients denied consuming oral narcotics and 1 woman required 50 mg of oxycodone. Patients’ subjective response to the amount of convalescent time needed prior to returning to their normal level of activity ranged from 2 to 30 days (mean, 7.8). Perioperative complications include 2 patients sustaining a bladder perforation that was recognized and repaired laparoscopically during the procedure. Postoperatively, 3 patients developed urinary retention and were discharged with a urethral catheter. One of these women required an indwelling catheter for 1 month. However, all cases of postoperative urinary retention subsequently resolved and these women are currently continent. Another patient developed an Enterococcus wound infection of the umbilical port that resolved with oral antibiotics and wound care. No patient required a perioperative blood transfusion. All 12 women were contacted in September 1994 with a mean follow-up of 20.8 months (range, 8 to 29). Ten women (83%) are completely continent and 2 (17%) have mild SUI without urgency Three women (25%) who are fully continent also have occasional urgency. One of these women had SUI with associated urgency preoperatively. One failure was a 67-year-old nulliparous woman who underwent a transabdominal approach. She
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was completely continent 14 months after surgery, but by 24 months she required 1 or 2 sanitary napkins per day for control of incontinence. The second failure was a 48-year-old gravida IV, para II woman who had a prior Stamey procedure in 1979. She underwent a transabdominal approach, sustaining a bladder perforation that was repaired intraoperatively She was completely continent at 12 months following surgery except for occasional urgency, but by 24 months’ follow-up was requiring 1 or 2 sanitary pads per day for control of incontinence. There were no additional risk factors that would identify a reason for failure in either patient. OPENGROUP
Ten Burch procedures were performed through a standard Pfannenstiel incision. Operative time ranged from 33 to 150 minutes (mean, 109). Blood loss ranged from 50 to 400 cc (mean, 153), with an average of 2080 cc of lactate solution administered intraoperatively (Table II). The mean change in hematocrit was 6.6%. Postoperative length of hospitalization ranged from 4 to 6 days (mean, 4.9). Narcotic requirements in the hospital averaged 131.4 mg (range, 70 to 296 mg) of morphine equivalents. Following discharge, 7 women subjectively rated their pain and oral narcotic use as “minimal,” 2 as “moderately severe,” and 1 could not precisely recall. Patients’ subjective response to the amount of convalescent time needed prior to returning to their normal level of activity ranged from 1 to 52 weeks (mean, 11). Complications include 2 patients who developed postoperative urinary retention and required an indwelling catheter for 2 and 5 weeks. One transient case of congestive heart failure occurred postoperatively and was successfully managed with diuretics. Two patients developed a urinary tract infection and another had a wound infection that resolved without sequela. No patient required a perioperative blood transfusion. U ROLOCYQ /APRIL1995I VOLUME 45,NUMBER 4
Seven patients (70%) were completely continent at a mean of 35.6 months’ (range, 11 to 50) follow-up. Three patients had evidence of SUI postoperatively Two of these women also had de novo urgency and required 1 to 2 sanitary pads per day, and the third patient did not experience urgency and required 3 to 5 sanitary pads per day for control of incontinence. Nonparametric comparison of medians using the Wilcoxon ranked sum test demonstrated statistical significance between the two groups of patients regarding length of hospitalization, postoperative analgesia requirements, return to normal activity, and mean operative time. Postoperative urgency and continence between the two groups were not statistically significant. COMMENT The Burch procedure, described in 1961, suspends the proximal urethra in a high retropubic position by securing perivaginal fascia and anterior vaginal wall to Cooper’s ligament. Advantages of this approach include simultaneous correction of mild cystocele, strong periosteal support, and lateral placement of suspension sutures, thereby avoiding urethral obstruction.1° With the Burch procedure, the sutures are placed more laterally than the MMK technique, minimizing the potential of urethral obstruction and osteitis pubis.ll The Burch colposuspension successfully restores continence in 84% to 94% within 1 to 2 years in most large series. 5~12~13This technique compares favorably with the various other surgical options, including needle suspensions, anterior colporrhaphy, and other open approaches such as the MMK and the Richardson paravaginal repair.5 Our laparoscopic continence rates are comparable to both open and other laparoscopic series. Albala and associates14 reported on 22 laparoscopic MMK procedures performed on women with grade I or II SUI. Results revealed all patients continent at 9.5 months. Liu and Paek15 performed 107 laparoscopic Burch procedures for an overall success rate of 97.2%, with follow-up ranging from 3 to 27 months. Of note, 87 of the 107 patients in this series underwent concomitant major laparoscopic procedures, including hysterectomy and salpingo-oophorectomy, and all 107 patients had a concomitant Moschcowitz procedure to obliterate the cul-de-sac. McDougall and associates16 reported a 80% success rate with 17 women who underwent either a modified laparoscopic MMK, Burch, or Richardson procedure. The interpretation of all of these results should be viewed with caution as the mean follow-up re-
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ported was short. Early resolution of SUI following surgical procedures does not guarantee longterm cure.5 We believe the 83% continence rate attained in our series with the laparoscopic Burch urethropexy is equivalent to the 70% continence rate following the open Burch repair (difference not significant). The colposuspension technique used in both the open and the laparoscopic groups was anatomically the same, as such the continence rates should be similar irrespective of the approach. Variability in outcome in this study is due to a relatively small number of patients in each group and differences in length of follow-up (mean: open, 35 months versus laparoscopic, 20.8 months). There are scant data in the literature documenting when during the postsurgical period failures of anti-incontinence surgery become apparent. In a review of the literature, Spencer and O’Conor5 determined that failures occurred anywhere between 6 months and 23 years postoperatively They concluded that accurate cure rates could best be determined with a minimum of 5 years of follow-up.5 Although operative time is longer, the laparoscopic approach appears to offer several benefits compared with traditional open retropubic suspensions. The advantages of the laparoscopic approach are reflected in a shorter length of hospitalization, reduced narcotic requirements, and a more expedient return to activity (Table II). These benefits have also been observed with other laparoscopic urologic procedures.17,18 Inadvertent bladder injury has been the most common intraoperative complication, resulting in prolonged operative time. Liu and Paek15 reported four such injuries in 107 patients, while Albala et a1.,14 Harewood,19 and McDougall et a1.16 each reported one bladder injury in each series. These injuries occurred early in all series. Typically, the vesical rent occurs at the dome of the bladder while initially gaining access to the space of Retzius using the transperitoneal approach. Fortunately, these injuries can usually be recognized intraoperatively and suture or stapled repairs have been successful. To avoid this injury, care must be taken in dissection, and the bladder wall should be identified. Bladder injury can also be avoided by filling the bladder with 150 cc of saline to delineate its boundaries during dissection. Iaparoscopic retropubic urethropexy affords excellent vision within the space of Retzius and allows for easy mobilization of periurethral tissue and placement of suspension sutures. Patients having
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had prior urethropexies can be approached laparoscopically. Previous abdominal procedures including total abdominal hysterectomy did not interfere with a successful outcome. In addition, bleeding from the anterior vaginal wall with suture placement was not observed in the laparoscopic group. We believe this is secondary to the intra-abdominal pressure created by the pneumoperitoneum. For women with prior lower abdominal surgery, an extraperitoneal approach is preferable. Although our experience with the extraperitoneal technique is limited to 3 patients, this approach did not prove to be more technically difficult than the transperitoneal approach, as operative time and blood loss were similar. Postoperatively, there was no difference in hospital stay or return to normal activity when compared with the transperitoneal approach. Ongoing series comparing transperitoneal and extraperitoneal laparoscopy should delineate the risks and benefits associated with each approach. Although this is not a prospective, randomized study, our data compare contemporary patients undergoing open and laparoscopic Burch colposuspension performed at one institution. Our data imply that the laparoscopic approach provides equivalent success with much less morbidity when compared with traditional open retropubic suspensions. McDougall and associates16 recently compared laparoscopic urethropexy to Raz urethropexy and found both procedures to be equally successful. The only 2 failures that occurred in 9 patients undergoing laparoscopic repair with follow-up of at least 1 year had undergone a modified laparoscopic MMK suspension. They concluded that the modified laparoscopic Burch or Richardson repair appeared to be more successful. Preliminary data of the small number of women studied suggest that this technique can provide successful outcomes in properly selected patients. Patients with anatomic SUI with or without a small cystocele can be offered a laparoscopic technique. Additional studies involving a larger cohort of women undergoing the laparoscopic Burch urethropexy need to be assessed before adequate conclusions regarding long-term continence can be drawn. Thomas J. Polascik, M.D. The Brady TheJohns
Urological
Institute
Hopkins Bayview Medical Center 4940 Eastern Avenue Baltimore, MD 21224
ACKNOWLEDGMENT. To Dr. Alan Partin for assistance in statistical analysis.
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REFERENCES 1. Goebell R: Zur operativen beseiligung der angeharenen incontinentia vesicae. A Gynak Urol2: 187, 1910. 2. National Institutes of Health Consensus Development Conference: Urinary incontinence in adults. J Am Geriatr Sot
38: 265-272, 3. Marshall
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VF, Marchetti AA, and Krantz KE: The correction of stress incontinence by simple vesicourethral suspension. Surg Gynecol Obstet 88: 509-518, 1949. 4. Burch JC: Urethrovaginal fixation to Cooper’s ligament for the correction of stress incontinence, cystocele and prolapse. Am J Obstet Gynecol 81: 281-290, 1961. 5. Spencer JR, and O’Conor VJ Jr: Comparison of procedures for stress urinary incontinence. AUA Update Series 6 (no. 28): 1987. 6. Pereyra AJ: A simplified surgical procedure for the correction of stress incontinence in women. West J Surg Obstet Gynecol 67: 223-226, 1959. 7. Vancaillie TG, and Schuessler W: Laparoscopic bladder neck suspension. J Laparoendosc Surg 1: 169-173, 1991. 8. Marchetti AA, Marshall VF, and Shultis LD: Simple vesicourethral suspension. A survey. Am J Obstet Gynecol 74: 57-63, 1957. 9. Acute Pain Management Guideline Panel: Acute Pain Management: Operative or Medical Procedures and Trauma. Clinical Practice Guideline. AHCPR Pub. No. 92-0032. Rockville, Md: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services. Feb 1992, pp 112-113. 10. Raz S, Little NA, and Juma S: Female urology, in Walsh PC, Retik AB, Stamey TA, and Vaughan ED Jr (Eds): Campbell’s Urology, 6th ed, vol 3, Philadelphia, WB Saunders Co, 1992, pp 2782-2828. 11. Zimmern PE, Hadley HR, Leach GE, and Raz S: Female urethral obstruction after Marshall-Marchetti-Krantz operation. J Urol 138: 517-520, 1987. 12. Van Geelen JM, Theeuwes AG, Eskes TK, and Martin CB Jr: The clinical and urodynamic effects of anterior vaginal repair and Burch colposuspension. Am J Obstet Gynecol 159: 137-144, 1988. 13. Stanton SL, Hertogs K, Cox C, Hilton P, and Cardozo L: Colposuspension operation for genuine stress incontinence, a five-year study. Proceedings of the XII annual meeting of the International Continence Society. Leiden: International Continence Society, 1982:94. 14. Albala DM, Schuessler WW, and Vancaillie TG: Laparoscopic bladder neck suspension. J Endourol 6: 137-141, 1992. 15. Liu CY, and Paek W: Laparoscopic retropubic colposuspension (Burch procedure). Gynecol Laparoscop 1: 31-34, 1993. 16. McDougall EM, Klutke CG, Clayman RV, and Cornell T: Comparative analysis of vaginal (Raz) and laparoscopic bladder neck suspension for type I or type II stress urinary incontinence (abstract 1085). J Urol 151: 499A, 1994. 17. Winfield HN, See WA, Donovan JF, Godet A, Farage YM, Loening SA, and Williams RD: Comparative effectiveness and safety of laparoscopic versus open pelvic lymph node dissection for cancer of the prostate (abstract 124). J Urol 147: 244A,1992. 18. Kavoussi LR, Kerbl K, Capelouto CC, McDougal EM, and Clayman RV: Laparoscopic nephrectomy for renal neoplasms. Urology 42: 603-609, 1993. 19. Harewood LM: Laparoscopic needle colposuspension for genuine stress incontinence. J Endourol 7: 319-322, 1993.
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