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ORIGINAL RESEARCH |
From the Department of Experimental Medicine, University of Catanzaro, Catanzaro, and the Department of Obstetrics and Gynecology, University of Messina, Messina, Italy.
Address reprint requests to: Stefano Palomba, MD, Divisione Universitaria di Ginecologia e Ostetricia, Ospedale "Pugliese," Viale Pio X, Catanzaro, Italy; E-mail: stefanopalomba{at}tin.it.
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: The sample size required was 30 subjects per group to detect a statistically significant estimated difference of 15% between two surgical procedures with an 
= 0.05 and a power of 0.7. Sixty women affected by genuine stress incontinence (GSI) were enrolled and randomly assigned to two groups of 30 women each. All women were treated with the transperitoneal laparoscopic Burch procedure using nonabsorbable sutures (group A) or Prolene mesh (Ethicon, Somerville, NJ) fixed with tacks or staples (group B). The failure rate was defined subjectively and objectively. The subjective evaluation was performed by asking the women to rate their urine loss on a visual analog scale. The objective evaluation was a clinical evaluation using multichannel urodynamic studies.
RESULTS: The subjective failure rate was not significantly different between the two groups at 3 months (0% for both groups), 6 months (3.7% versus 3.8% for groups A and B, respectively), and 12 months (7.4% versus 15.4% for groups A and B, respectively) after surgery. At 3 months (3.7% versus 3.8% for groups A and B, respectively) and 6 months (7.4% versus 15.4% for groups A and B, respectively) follow-up, the objective failure rate was not significantly different between the two groups. However, at 12 months after the surgical procedure, the objective failure rate was significantly lower in group A than in group B (11.1% versus 26.9%, respectively; P < .05).
CONCLUSION: Transperitoneal laparoscopic Burch colposuspension performed using sutures was more effective than the mesh technique.
Genuine stress incontinence (GSI) is the involuntary leakage of urine on a sudden increase of intra-abdominal and intravesical pressures during coughing or sneezing in the absence of urethral sphincter weakness.1 The prevalence of GSI is high and, at present, it is the most common cause (40–60%) of incontinence in women.1
More than 150 surgical procedures have been described in the literature for treatment of GSI. Among the available techniques, the Burch retropubic colposuspension,2 first performed in 1961, is considered the gold standard for treatment of GSI and it is associated with a success rate of 70–95% ( Hernandez-Rey AE, Agrama S, Medina CA. A review of two surgical procedures in the management of genuine stress urinary incontinence: A survey of overall patient satisfaction [abstract]. Obstet Gynecol 2000;95:S24; Summitt RL, Lucente V, Karram MM, Shull BL, Bent AE. Randomized comparison of laparoscopic and transabdominal Burch urethropexy for the treatment of genuine stress incontinence [abstract]. Obstet Gynecol 2000;95:S2).3–9
Classical Burch colposuspension is based on the fixation of non-absorbable separated sutures between the vaginal fascia and Cooper ligament, placed between the mid-urethra and bladder neck. In 1991 Vancaille and Schuessler10 introduced the laparoscopic approach to the Burch procedure. Since then, significant advantages of laparoscopic colposuspension over laparotomy have been shown. It uses a smaller and more cosmetic incision; it allows for easier access to the space of Retzius, better visibility of the operative field, and minimal intra-operative blood loss and postoperative pain; and there is less need of analgesia, quicker recovery time, shorter hospital stay, and an earlier return to work.11–15
Two approaches of laparoscopic Burch procedures are described in the literature—transperitoneal and pre-peritoneal.16 In both techniques the fixation can be performed by means of different devices, such as mesh,17 clips,18 tacks,19 fibrin glue,20 and sutures.21
The aim of our study was to compare two different transperitoneal laparoscopic Burch colposuspension procedures.
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MATERIALS AND METHODS |
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ABSTRACTMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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From May 1996 to April 2000, 668 ambulatory women with urinary incontinence were screened consecutively to enroll in our study, and 60 women affected by mild and moderate GSI without the exclusion criteria enrolled.
Genuine stress incontinence was defined as involuntary loss of urine when the intravesical pressure exceeds the maximum urethral pressure in absence of detrusor contraction. The urethral hypermobility was evaluated with the cotton-swab test (Q-tip test).22 The Q-tip test was considered positive if the excursion of a cotton swab placed in the proximal urethra, measured during straining, exceeded 30 degrees.
Detrusor instability was defined by the occurrence of uninhibited detrusor contractions greater than 15 cm H2O. The intrinsic sphincter dysfunction was defined as a low urethral pressure (less than 20 cm H2O) and a Valsalva leak point pressure less than 60 cm H2O.
Exclusion criteria included severe GSI (loss of urine with minimal physical activity), with associated prolapse equal to or more than second degree, previous pelvic or anti-incontinence surgery, history of severe abdomin-opelvic infections or known extensive abdominopelvic adhesions, and detrusor instability and/or intrinsic sphincter dysfunction. The presence of other gynecologic pathologies (eg, fibroids, ovarian cysts) was also considered a reason for exclusion. Women with a body mass index (BMI; kg/m2) over 30 were excluded.
Pelvic prolapse was graded using the Baden scale23 during straining in the standing position.
At admission, a complete history was obtained and physical evaluation was done. The physical evaluation included gynecologic and neurologic examinations. In particular, the neurologic integrity of S2–S4 was evaluated by testing the sensation of inner thighs, vulvar and perirectal areas, and bulbocavernous reflex. A multichannel urodynamic study was performed in all cases by the same experienced urologist with the same multichannel recorder. The urodynamic evaluations consisted of uroflowmetry, cystomanometry with pressure-flow study, and urethral pressure profiles. Preoperative assessment included the cough stress test, Q-tip test, bacterial culture of a midstream urine specimen, pelvic ultrasound with evaluation of postvoiding residue, and video cystourethroscopy. Before surgery all patients gave subjective reports of urine loss after cough, strain, or bounce on the heels during the sensation of bladder fullness using a visual analog scale (VAS) graded from 0 to 10. A value of 0 was used to define a dry sensation, and a value of 10 as severe leakage. The same evaluations were performed at 3, 6, and 12 months after the surgical procedure.
Micronized estradiol (E2) (Estrofem, Novo Nordisk, Italy; 2 mg per day per os) in association with medroxyprogesterone acetate (Farlutal, Pharmacia & Upjohn, Italy; 2.5 mg per day per os) was given to all postmenopausal women during the 4 weeks before surgery.24
Using a computer-generated randomization list, eligible subjects were divided into two groups (group A and group B) of 30 women each. All women underwent a classical transperitoneal laparoscopic Burch urethrocolpopexy with two different types of fixation. Specifically, in group A, a single or double nonabsorbable suture was used, whereas in group B we used nonabsorbable mesh fixed with tacks or staples both on the vaginal fascia and Cooper’s ligament.
In all patients blood was sampled before and after surgery. The red blood cell count (normal range 4–5 x 106/mL), hematocrit (normal range 38–48%), serum hemoglobin (normal range 13.0–16.5 g/dL), and iron (normal range 40–160 g/dL) levels were measured. The variation of hemoglobin (
Hb) levels was calculated for each woman.
The same experienced operator (F.Z.) performed the laparoscopic Burch procedures. After induction of general anesthesia, the patient was placed in the low lithotomic position in order to perform pelvic laparoscopy and vaginal manipulations. Immediately before surgery, 3 g of ampicillin-sulbactam was given intravenously.25 A Foley catheter was inserted to provide bladder drainage throughout the operation. After the creation of pneumo-peritoneum, a 10-mm operative videolaparoscope was inserted umbilically, two 5-mm ancillary trocars were inserted laterally, and one 10-mm trocar was inserted on the midline halfway between the umbilicus and pubis. To enter the space of Retzius intra-abdominally, the umbilical ligaments were identified laterally, and the parietal peritoneum was incised transversally by means of unipolar diathermy after delineating the bladder dome with 200 mL of methylen blue. The space was dissected from the anterior abdominal wall to visualize Cooper’s ligament. The retropubic space was exposed with blunt dissection and careful bipolar cautery of all small vessels, staying close to the back of the pubic bone, emptying the bladder, and dropping it downward together with the vaginal wall and urethra. Beginning laterally, the bladder was dissected to identify the paravaginal fascia.
In group A one or two nonabsorbable sutures (0-Ethibond; Ethicon, Pratica di Mare, Rome, Italy) were placed at the level of the midurethra without penetrating the vaginal mucosa and fixed to Cooper’s ligament with a tension-free knotting technique (about 2 cm between Cooper’s ligament and the paravaginal fascia). The decision to use one or two sutures was made during the procedure according to the anatomy of the patient. In the case of a single suture, an helicoid throw on the vaginal fascia at the mid-urethra level and a single passage on Cooper’s ligament was used. When a second suture was used, it was applied at the level of the urethrovesical junction. In group B we used nonabsorbable mesh (polypropylene, 0.5 x 3 cm) fixed with tacks (Origin Medsystems, Menlo Park, CA) or staples (Endopath EMS, Ethicon, Pratica di Mare, Rome, Italy; Multifire Endo Hernia, Tyco Healthcare Italia S.p.A., Milan, Italy). No additional surgical procedures were performed. A cystoscopy was done in all women at the end of the procedure to exclude urethral and bladder injuries.
All patients received intravenous pain drugs for 4 hours after surgery. Women were allowed to eat and drink the evening of surgery and could ambulate as soon as they felt comfortable. The urinary catheter was withdrawn about 24 hours after the operation.
All intraoperative and postoperative complications of the two surgical techniques were recorded carefully. Duration of the surgical procedure, blood loss, catheterization time, rate of patients resuming spontaneous voiding at 24 hours, and hospital stay were also recorded. The blood loss was expressed as the difference between the aspirated and the irrigated liquid and as Hb.
Failure was evaluated subjectively and objectively. The subjective evaluation of failure was done by comparing the visual analog scale score obtained before surgery with that obtained after surgery in each woman. Subjective failure was defined as a postoperative visual analog scale value equal to or higher than that obtained before surgery. The objective cure failure was defined as involuntary loss of urine during cough and Valsalva maneuver in the standing position with the bladder filled to maximal cystometric capacity during clinical observation or abnormal urodynamic tests. The researcher evaluating the objective cure rate was masked with regard to the surgical procedure performed.
The objective failure rate at 12 months after surgery was our primary end point variable. By using the English-language literature, we estimate the objective failure rate after surgery using procedure A (reference group) is between 5% and 30%. If we observe, in the patients enrolled by our center, an objective cure failure rate equal to 10% for procedure A (reference group), we define an objective failure rate less than or equal to 15% for surgery procedure A as clinically remarkable . Therefore, by defining 
A as the objective failure rate for procedure A and B as the objective failure rate for procedure B, we can verify our two-tailed test hypothesis as follows: H0: A - B < 0.05 versus the alternative hypothesis, Ha: A - B 
0.05. Power analysis required 30 patients per group to define as statistically significant the estimated difference of 15% between groups with = 0.05 and ß = 0.30 (power of 70%).
Unpaired Student t test or Mann-Whitney U test for independent groups of data were used as appropriate to compare age and BMI, and to evaluate catheterization length and hospital stay.
Wilcoxon rank-sum test was used to compare parity, duration of operation, and intraoperative blood loss. The difference in cure rate between the groups was evaluated with the 
2 test. The Fisher exact test was used to compare the incidences of complications between groups. Statistical analysis was performed using SPSS 9.0 software (SPSS Inc., Chicago, IL). The statistical significance was set at P < .05. Data were expressed as mean ± standard deviation (SD).
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RESULTS |
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The characteristics of the patients are reported in Table 1
. At entry, no significant differences were detected between the two groups in age, parity, BMI, number women who smoked, duration of incontinence, and percentage of women in postmenopause and with mild and moderate GSI (Table 1). There were no differences among the two groups in the main urodynamic parameters (Table 1).
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The laparoscopic operations were completed successfully in all women, and no case was converted to laparotomy. No significant differences were detected between the two groups in bladder injuries (3.7% in group A compared with 3.8% in group B) and in detrusor instability (7.4% in group A compared with 11.5% in group B). No uretheral injuries were observed. The two cystotomies were about 1 cm and were successfully repaired laparoscopically in two layers with 2/0 polyglactin (Vicryl, Ethicon, Pratica di Mare, Rome, Italy). No other complications were noted during the study.
The bladder catheter was removed from all patients 24 hours after the operation. No significant differences were observed between the two groups in operative time, blood loss, and postoperative hospital stay (Table 2).
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The subjective and objective failure rates for both groups at 3, 6, and 12 months after surgery are summarized in Table 3. All women in both groups were satisfied and were dry 3 months after surgery. The subjective failure rate was not significantly different between the two groups at 6 months (3.7% in group A compared with 3.8% in group B) and 12 months (7.4% in group A compared with 15.4% in group B) after surgery. In all cases of subjective failure, the urodynamic study confirmed persistent urethral sphincter incompetence.
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Before surgery, the red blood cell count, hematocrit, serum hemoglobin, and iron levels were not statistically different between the two groups (Table 1
). Those variables were similar in both groups after surgical intervention (data not shown). In particular, Hb was not significantly different between the groups (0.81 ± 0.65 compared with 0.73 ± 0.71 for group A and group B, respectively).
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DISCUSSION |
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The aim of the present study was to compare specifically two different surgical procedures using the trans-peritoneal approach. We have preferred the transperitoneal to the extraperitoneal approach because it has a better view and a larger and drier operating space. In addition, the transperitoneal technique allows the surgeon to examine the abdominal cavity and to deal with unexpected or coexisting intra-abdominal pathologies. Another advantage of the transperitoneal technique is that it allows the surgeon to perform prophylactic enterocele repair or to treat an enterocele or a mid-to-high rectocele as well as vaginal vault prolapse without the need for a separate vaginal procedure.30
As reported in other studies,16,31,32 there were no significant differences in blood loss and postoperative hospital stay between women treated with classical sutures or with mesh.
The rate of surgical complications was very low in both groups and comparable with other studies ( Hernandez-Rey et al, Obstet Gynecol 2000;95:S24).6,7,32 In our series, only two bladder injuries (one woman in each group) and detrusor instability (two women in group A and three in group B) and no urethral injuries were observed.
The objective failure rate was not significantly different between the two groups 3 months after surgery. Nevertheless, at 12 months after surgery a significantly lower objective failure rate was observed in group A compared with group B. In addition, no significant difference among groups was reported in rate of patients resuming spontaneous voiding at 24 hours. Furthermore, contrary to previous reports showing that the mesh and staple technique seems to be significantly faster,14,17 the operative time noted during the present study was similar for both groups.
Many attempts at simplifying laparoscopic procedures and reducing the learning period, especially suturing, have led to the development of various tools to replace free-hand suturing. In fact, laparoscopic suturing necessitates coordination between endoscopic visualization and placement of a curved needle into tissue, whereas the use of Prolene mesh fixed with tacks or staples reduces the technical complexity of the procedure and potentially shortens the total operative time. In addition, it has been reported that the techniques using mesh and surgical stapler decreased learning time for laparoscopic colposuspension.14
In our study no real advantage was found with the use of Prolene mesh fixed with tacks or staples if the procedure was performed by an operator with good laparoscopic suturing experience. On the contrary, the use of simplified laparoscopic procedures seems to reduce the cure rate of laparoscopic colposuspension after 1 year of follow-up. In addition, the use of suture has a much lower cost in comparison with mesh fixed with tacks and staples. The cost of mesh is $350 and of tacks or staples is approximately $560, whereas the cost of the nonabsorbable sutures varies from $15 to $30, depending on the brand and the number of sutures applied.
We believe that an experienced operator using the laparoscopic Burch procedure should use an identical operative technique for laparotomic procedures to achieve the same results. The choice of suture materials, the strength, and the number of the sutures are critical to achieve a high laparotomic or laparoscopic cure rate after long-term follow-up.28,32 In fact, the differences in laparotomic and laparoscopic Burch procedures should regard only the access to the space of Retzius.33
Other important issues in anti-incontinence surgical procedures are how to evaluate the surgical outcome of the different techniques and whether the effectiveness should be studied by subjective or objective determinations. Our findings show that after 1 year of follow-up there was a difference between subjective and objective outcomes. In fact, in our population many patients with objectively detected recurrence of GSI did not report urinary symptomatology because of the improvement of the symptoms in comparison with baseline. We maintain that the goal of surgical intervention is the relief of symptoms and the improvement of quality of life.
The use of nonabsorbable sutures gave significantly better surgical results at lower cost compared with use of Prolene mesh fixed with tacks or staples. Despite the enthusiasm for these, it is clear at this time that suturing remains the best approach for laparoscopic colposuspension techniques. Long-term studies with at least 5 years of follow-up on a larger sample are necessary because of a time-dependent decrease in cure rate after anti-incontinence surgical procedures.6
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Footnotes |
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Received March 12, 2001. Received in revised form June 20, 2001. Accepted July 16, 2001.
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REFERENCES |
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2. Burch JC. Urethrovaginal fixation to Cooper’s ligament for the correction of stress incontinence, cystocele, and prolapse. Am J Obstet Gynecol 1961;88:281–90.
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