Stress urinary incontinence (SUI) represents the most common type of incontinence in women [1]. It affects about 10% to 30% of females aged 15 to 64 years [2]. Its prevalence is usually underestimated as many women with SUI suffer in silence [3,4]. It is defined as the involuntary leakage of urine on effort, exertion, sneezing or coughing, in absence of detrusor over activity [5].

SUI in women is a condition that presents significant medical, social and psychological consequences. Surgery represents the most effective treatment modality and is commonly used for treatment [6]. Nearly, 300 procedures have been proposed for treatment of SUI, but only few have survived with enough supportive evidence to be recommended [7].

Retro pubic colposuspension by Burch is one of the most commonly used techniques. Current trends towards performing less invasive surgeries with shorter hospital stay period, lower complications and faster recovery of patients led to the development of laparoscopic surgery. In 1991, Vancaille & Schussler described the Burch colposuspension by laparoscopic approach [6].

The aim of this study is to compare efficacy and complications of open surgical versus laparoscopic Burch colposuspension for treatment of urodynamic stress urinary incontinence and to demonstrate the presumed advantages of laparoscopic approach.

Women presenting with significant symptoms of stress urinary incontinence (significant medical, social and psychological consequences.), were candidates for the study during the period between October 2014 and October 2017.

Women who predominantly had urge incontinence, had been previously operated on for stress urinary incontinence, not completed their family (planning to have children in the future) were excluded from the study. Women regarded to be at increased risk of complications during general anesthesia (patients with cardiovascular diseases), or during laparoscopic surgery (suspected intraintraperitoneal adhesions and/or abdominal obesity were also excluded from the study. Written informed consent was obtained from all patients after detailed explanation of surgical procedures and its risks before enrollment in the study. Eligible patients were They were randomized in a proportion of 1:1 to either open surgical colposuspension (group A) or laparoscopic colposuspension (group B) randomization done using a computer-generated random sequence and the randomization list was held in a secure box and the participants were assigned to their groups using sequentiallynumbered opaque sealed envelopes that were opened at the start of study.

All patients were preoperatively assessed by standard history, physical examination, urodynamic investigation (to exclude detrusor over activity) and performed one hour pad-test for objective assessment of urinary incontinence.

One hour pad-test was performed in the following way: The patient was asked to empty her bladder. Any remaining urine was evacuated using a sterile urinary catheter. Then, the bladder was filled with 300 ml sterile saline at room temperature. The woman was given a preweighed sanitary pad to put on her underwear and instructed to perform a standardized physical activity during 1 hour. The sanitary pad was weighed after 1hour to estimate the volume of urinary leakage.

In group A, Burch colposuspension by open approach, fixation of foley's catheter was done, then a low Pfannenstiel incision was performed. Retzius space was dissected extraperitoneally, allowing approach to the urethra, bladder neck and Cooper's ligament, aided by the identification of the vaginal dome through presentation with vaginal mounted gauze or 2 fingers in the vagina and palpation of the Foleys' catheter balloon. Then 2 stitches were applied on each side with polypropylene 0 suture between the vaginal dome, just at the level of bladder neck, and Cooper's ligament with minimal tension.

In group B, the laparoscopic colposuspension was performed by trans peritoneal approach through 4 punctures: 10-mm puncture in the umbilicus for telescope with video camera, another two 5 mm ports in the left and right lower quadrants lateral to the inferior epigastric arteries approximately two fingerbreadths medial to and above the anterior superior iliac spine and one 10 mm puncture with reducers in the suprapubic areas. All other steps were similar to open surgery. Two stitches were applied on each side of the bladder neck in all patients. All sutures were tied by intra-corporeal knotting technique. When tying the sutures, too much tension was avoided and a suture bridge of 1.5 to 2.0 cm was left.

General anesthesia was used in both groups and prophylactic antibiotics were given in the form of ceftriaxone 1 gram which is repeated 12 hours postoperatively.

Postoperatively, patients received analgesics in the form of diclofenac sodium 75 mg intramuscular injection and Paracetamol 1000 mg intravenous infusion with recovery from anesthesia. Another dose of diclofenac sodium 75 mg was given 12 hours later.

Urinary catheter was removed 24 hours postoperatively. Any patient with urinary difficulty or retention, catheter re-insertion was done, and reevaluated 1 week later with voiding trial at outpatient clinic.

All patients were discharged from hospital once they can tolerate regular meals and after adequate pain control.

The primary outcome measures were assessment of objective and subjective cure rate at 1, 6 and 12 months after the procedure. Subjective outcome was ‘satisfied or unsatisfied’ to the question (are you satisfied with the outcome of the procedure or not?) while the objective cure was measured by 1-hour pad test.

The secondary outcome measures included: Operative time, intra operative blood loss, operative morbidity (return to operating theatre or bladder injury), hospital stay in hours, voiding difficulty, wound infection, urinary tract infection and postoperative pain. Postoperative pain was measured by revised face pain scale 12 hours postoperatively.

Intraoperative blood loss during open technique was measured as follows: the soaked towel means about 150 cc and the soaked sponge means 5cc blood loss. During laparoscopy the amount of blood loss was estimated by the amount in the suction container after subtracting the amount of fluid used for washing. Postoperative pain was assessed by visual analogue scale (VAS; 0 mm = absence of pain, 100 mm = unbearable pain).

Sample size

By estimated blood loss in a study done by Carey et al. in 2006, which was 126 ml in laparoscopic group and 170 ml in open surgical group, so with power 80% and confidence 95%, sample size was 41 in each group, with 20% non-responder rate, so it was 50 in each group.

Statistical analysis

Data collected throughout history, basic clinical examination and outcome measures coded, entered and analyzed using Microsoft Excel software. Data were then imported into Statistical Package for the Social Sciences (SPSS version 20.0) (Statistical Package for the Social Sciences) software for analysis. According to the type of data qualitative represent as number and percentage, quantitative continues group represent by mean ± SD, the following tests were used to test differences for significance; Differences between frequencies (qualitative variables) and percentages in groups were compared by Chi-square test. Differences between parametric quantitative independent groups by t test, paired data by paired t test. P value was set at <0.05 for significant results & <0.001 for high significant result.

Total of 137 cases attended the outpatient clinic during the study period and were assessed for the eligibility and 118 Patients were fitting to the inclusion criteria. The study protocol, the intervention involved, possible early and long term side effects of interventions were explained to the patients.

Out of which, 104 patients were willing to participate in the study and consented for participation. Simple randomization of those 104 patients was done; 52 patients in each group. 9 patients were dropped from follow up (4 and 5 from group A and B respectively). So, finally 95 patients were analyzed (48 and 47 patients from group A and B respectively).

Preoperative patients' characteristics were comparable in both groups Table 1. Operative time was significantly longer in laparoscopic group than open group. However, pain score and hospital stay were significantly shorter in laparoscopic group. While, intraoperative blood loss was slightly lower in laparoscopic group Table 2.

Table 1: Preoperative patients characteristics.

Table 2: Operative time, estimated blood loss, pain score and hospital stay.

There was no statistically significant difference in the incidence of intraoperative or postoperative complications as shown in table 3. There were no major intraoperative or postoperative complications.

Table 3: Complications.

Two cases of bladder injury were recorded in laparoscopic group while approaching retro pubic space and repaired laparoscopically with two interrupted sutures. Three cases of superficial wound infection were detected, two cases in open group and one case in laparoscopic group.

All were managed with suture removal and regular dressing Table 3.

Regarding post-operative urinary problems there was no significant difference between both groups as shown in. Ten cases suffered postoperative urgency at one month follow up; four cases were noticed in open group (8.3%) and six cases in laparoscopy group (12.7%). Filling cystometry was done to confirm presence of detrusor over activity. Antimuscarinic drug was given (solifenacin) 5mg one tablet daily.

Three months later the condition improved in all cases. Regarding postoperative urine retention it was detected in four cases two in each group (4%) and was managed by weekly appointment in outpatient clinic for catheter removal and a repeat trial of voiding. Spontaneous gradual improvement was noted and no additional procedures were needed.

Regarding success rate assessed objectively by one hour pad test there was no significant difference between both groups during 1, 6 and 12 months follow up Table 4.

Table 4: Objective assessment for clinical improvement by one hour pad test.

There was no significant difference between both groups regarding patient satisfaction during follow up at 1, 6 and 12 months follow up as shown in Table 5.

Table 5: Patient satisfaction.

This study aimed to investigate the benefits and feasibility of using laparoscopic colposuspension in management of urodynamic stress incontinence in comparison to open approach.

There was a highly significant difference in the operative time between both groups with the shorter time being observed in group A. Open technique took 52.2 ± 4.3 minutes, while laparoscopic approach took 94 ± 6.4 minutes. This can be explained by technical difficulty of approaching retro pubic space and laparoscopic suturing. Mean operative time for laparoscopic colposuspension in our study was similar to that reported by Carey et al. 87 minutes [8] and Miannay et al. 89 minutes [9]. On the other hand, it was longer than that reported by Persson & Hanssen 60 minutes [10], this may be due to placing only one suture on each side in their study and also longer than Bulent et al. 46 minutes [11] and this may be due to their extra peritoneal approach. While it was shorter than Walter et al. 189 minutes [12] who added concurrent vaginal prolapse repair.

The mean amount of estimated blood loss in the group A was insignificantly higher (148.2 ± 31.3 ml) than group B (139.3 ± 28.7 ml). There is a wide variation between the literatures. Our results coincide with the results of Polascik et al. who found that mean amount of blood loss about 108 mL (20-300) in laparoscopy group and 153 mL (50-400) in the open group which is also statistically insignificant [13]. While the results of Ankardal et al. show that open group 105mL had significantly more blood loss than laparoscopic one 35 mL [14]. Carey et al. also found significant difference between both groups with more mean blood loss in open group 170 mL than laparoscopic group 126 mL [8]. On the other hand the mean amount of blood loss was insignificantly more in the laparoscopy group 270mL than the open group 240mL according to Walter et al. [12].

In our study, visual analogue scale showed a significantly higher score in group A (7.4 ± 1.2) than group B (3.0 ± 1.9). That coincides with Carey et al. [8] and Polascik et al. [13]. Miannay et al. also found laparoscopic technique significantly less painful than open one but with different method for pain assessment according to type of and doses of analgesic given [9]. Mais et al. stated that post-operative pain is mainly dependent on length of skin incision rather than operative procedures done, that explains why laparoscopic approach is significantly less painful in most studies [15].

Mean duration of hospital stay in group A was significantly longer (99.4 ± 12.3 hours) than that in group B (75.3 ± 9.5 hours). That is expected as laparoscopic approach had less post-operative pain and rapid recovery. Our results coincide with the results of Miannay et al. [9] who found the mean duration of hospital stay 160.8 hours in open group and 72 hours in laparoscopy group which is also statistically significant. While Carey et al. found insignificant difference between both groups with more mean duration of hospital stay in open group 93.6 hours than laparoscopic group 88.8 hours [8]. Our results in laparoscopic group regarding hospital stay was more than Bulent et al. who compared between trans peritoneal and extra peritoneal laparoscopic approach with mean duration of hospital stay of 43.2 and 37.6 hours respectively [11].

Regarding the incidence of intraoperative and postoperative complications, no statistically significant difference was detected in both groups. That coincides with most of literatures as Miannay et al., Bulent et al., Walter et al. and Ankardal et al. [9,11,12,14]. Kitchener et al. found that bladder injury is insignificantly higher in laparoscopy group (2.8%) than open group (0.7%) and that wound infection is significantly higher in open one [16].

Post-operative urinary problems were more in group B, but still with no significant difference between both groups. There was no significant difference in the incidence of urgency in the laparoscopic approach (12.7%) compared to the open approach (8.3%). This coincides with the study by Lavin et al. in which the incidence was 6% following laparoscopic colposuspension compared to 7.6% for open surgery at 6-month follow-up [17]. Also Carey et al. recorded no significant difference between both groups [8].

No significant difference between both groups as regards objective assessment during follow up at 1, 6 and 12 months. Kitchener et al. found negative one hour pad test at 6 months follow up in 84.5% of patients of open group and in 85.4% of laparoscopic group; And at 12 months results was 77.6% and 80.4 respectively. This is also insignificant between both groups [16].

Regarding patient satisfaction there was no significant difference between both groups during follow up at 1, 6 and 12 months and also no significant change noticed over time in both groups. There were some differences noticed between objective cure rate and patient satisfaction, as the latter is affected by other factors as hospital service, post-operative urinary problems as urgency and difficult voiding. Carey et al. found no significant differences regarding patient satisfaction At 24 months follow up with 70% for open group and 58% for laparoscopic group [8]. Kitchener et al. noted 58.1% for open and 66.2% for laparoscopy at 12 months; this was also insignificant [16].

Laparoscopic Burch colposuspension is a better approach than open surgical Burch in terms of hospital stay, postoperative pain and recovery, but it needs long learning curve and has longer operative time.