Stesura Seveso Archivio Italiano di Urologia e Andrologia 2023; 95, 2 78 ORIGINAL PAPER cure rate and lower incidence of complications, such as uri- nary tract infections, pelvic hematoma, and bladder/vaginal perforation (8, 9). The TOT sling method is regarded as the gold standard in the treatment of female SUI (10). Retropubic polypropylene mesh supports the urethra with- out tension, which was originally used in the initial approach, has now been modified to provide the same ther- apeutic benefits with fewer complications (11, 12). By avoiding the retropubic area, the TOT helps prevent hematoma and bladder perforation development in this area (13). These mid-urethral slings (MUS) procedures, how- ever, also have complications owing to the blind transit of the introducer needles via obturator foramen. Although groin pain has been reported to occur at a rate of 2-7.5% in certain studies, more significant complications such as vas- cular injury may also occur (11). A novel minimally inva- sive technique for treating SUI, known as single incision mini- slings (SIMS), was proposed as a way to reduce postopera- tive pain and eliminate blind passing trocars via the Retzius space and obturator canal with less mesh (14, 15). In this study, we aimed to evaluate the safety and efficacy of sur- geon-tailored polypropylene mesh (STM) through a needle- less SIMS vs. standard TOT in the treatment of female SUI. METHODS The local ethics committee approved the protocol of the current trial of Faculty of Medicine for girls, Al-Azhar University (FMG-IRB) met at Faculty of Medicine for Girls, Nasr City, Cairo, Egypt (Registration Number: 29042019). Only women who were able to read and sign the informed consent were included. All procedures run in compliance with the standards of the Declaration of Helsinki (16). The reporting of the present manuscript followed the CONSORT statement (17). Study design and patients We conducted an open-label randomised controlled trial that included women with SUI, who were scheduled to undergo surgical management at Al Zahraa University Hospital in Cairo, Egypt, from February 2019 to June 2022. Adult women with a confirmed diagnosis of SUI through a positive stress test were included if they exhib- ited no response to pelvic floor exercise. There were no restrictions regarding the severity of SUI or the presence of cystocele. We excluded women with tumours of the To evaluate the safety and efficacy of surgeon-tailored polypropylene mesh (STM) through a needle-less single incision mini-slings (SIMS) vs. standard trans-obturator tape (TOT) in the treatment of female stress urinary incontinence (SUI). Methods: We conducted an open-label randomized controlled trial that included women with SUI. Eligible women were ran- domized in a 1:1 ratio to receive either standard TOT or SIMS techniques. All procedures were performed using a surgeon-tai- lored polypropylene mesh and monofilament tape. Results: A total of 60 women were included. The mean operative time was significantly longer in the standard TOT group. The mean bleeding rate was significantly higher in the standard TOT group (87.6 ± 10.6 cc) compared to the SIMS group (60.0 ± 8.1 cc). There was no urethral injury in both groups. Transient thigh pain occurs in 12 cases (40 %) of the standard TOT and no cases in the SIMS group (p < 0.001). After three months, there was no significant statistical difference between the result of the two groups as regard to cure or improvement rate. No failed cases were reported in both groups (p = 0.64). Likewise, there was no significant difference between the two groups regarding patients' satisfaction rate. Conclusions: SIMS was not inferior to standard TOT. STM SIMS is a mini-invasive, relatively safe, reproducible, easy to perform in a short time, with excellent patient tolerability and minimal pain, allowing early return to work and economically effective surgical procedure for the treatment of female stress urinary incontinence. KEY WORDS: Contasure-needleless; Single-incision needleless mini- sling; Stress urinary incontinence; Transobturator inside-out. Submitted 28 March 2023; Accepted 30 April 2023 INTRODUCTION Stress urinary incontinence (SUI) is a complaint of involun- tary urine leakage triggered by coughing, sneezing, exer- tion, or effort. According to age, geographic location, and race, SUI prevalence varies from 5 to 61%, with yearly inci- dence rates of 4-11% and remission rates of only 4-5% (1- 3). Particularly in developing countries, SUI continues to be a substantial health burden (3). There have been sever- al surgical methods developed throughout time to treat female SUI, including tension-free vaginal tape (TVT) and trans-obturator tape (TOT) (4, 7). Both of these surgical approaches are widely accepted for the treatment of SUI. However, TOT became more popular owing to its same Single-incision needleless mini-sling technique for female stress urinary incontinence: A comparative study with standard transobturator inside-out technique Eman Ali, Salah E. Shebl, Sayeda Ibrahim Urology Department, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt. DOI: 10.4081/aiua.2023.11342 Summary Archivio Italiano di Urologia e Andrologia 2023; 95, 2 Eman Ali, Salah E. Shebl, Sayeda Ibrahim 79 genitourinary organs, infection, neurogenic bladder, and pregnant women. Eligible women were randomised in a 1:1 ratio to receive either standard TOT or SIMS tech- niques. All procedures were performed using a surgeon- tailored polypropylene mesh and monofilament tape. Preoperative assessment Preoperatively, all women were assessed for the presenta- tion, duration, and severity of SUI through the question- naire described by Sand et al. (18). Besides, patients were evaluated for associated genitourinary or neurological conditions and bowel habits. General medical, obstetric, and gynaecological histories were evaluated as well. All women underwent routine physical examination and pre- operative laboratory assessment, including complete blood count (CBC), liver and renal functions, bleeding profile, and urine culture. Abdominopelvic ultrasonography was performed for all women to assess post-void residual urine. All patients underwent cytometry preoperatively via Andromeda Urodynamic apparatus. Surgical procedures In both groups: – patients received prophylactic antibiotics one hour before the procedure (1gm 3rd generation cephalosporin intravenously); Figure 1 (A-H). Standard transobturator tape (TOT) procedure. A. Paraurethral space was bluntly dissected (at 2 o’clock position) until the descending ischiopubic ramus was reached. B. Tape applicator (needle) passing through tract created using out-in technique by supination movement. C. Needle through tract with its tip out of vaginal incision. G. Removal of excess tape outside the skin and closure of incision by vicryl 3/0. H. Closure of vaginal incision by vicryl 3/0 in interrupted manner. D. Mesh was fixed to the needle and drawn out through the thigh by pronation movement. E. Receiving the needle on index finger through tract. F. Suburethral straightening of the tape by using the back of a toothed forceps that was placed between the tape and the urethra. – procedures were performed under spinal anesthesia and in lithotomy position, with a 16 F bladder catheter inser- tion; – labia were retraced using a 3.0 silk stay suture; – a vaginal incision was done; – Allis clamps were applied at each side of the midline to suspend the anterior vaginal wall; – hydrodissection of the vaginal mucosa was performed; – vaginal wall was incised 1 cm on the sagittal line start- ing 1 cm below the urethral meatus. In the standard TOT group: – the mesh was prepared using a 30 x 30cm monofila- ment mesh; – periurethral fascia was dissected laterally using Metzenbaum scissors toward the inferior pubic ramus at each side; – a skin incision was made at the adductor longus tendon base parallel to the clitoris; – a needle was passed from this incision to the vaginal incision; – surgeon-tailored mesh was fixed to the needle and guid- ed throughout the thigh; – to obtain a tension-free procedure a non-toothed for- ceps was placed between the sling and the urethra to avoid twisting of the tape; Archivio Italiano di Urologia e Andrologia 2023; 95, 2 80 Single-incision needleless mini-sling technique for female stress urinary incontinence – the patient was asked to cough to assess the correction of stress incontinence; – a 3-0 vicryl suture was used to close the skin and vagi- nal incisions in sub-cuticular and interrupted fashions, respectively; – the vagina was packed with a povidone-iodine-soaked pack, and the urethral catheter was connected to closed-bag drainage (Figure 1). In the SIMS: – the mesh was prepared using 15 x 15 cm monofilament mesh (polypropylene mesh; Prolene, Ethicon Ltd., UK) to prepare T-pocket shaped strips of a total length of 12.5 cm; Figure 2 (A-L). Needle-less single incision mini-sling (SIMS). C. Suburethral longitudinal midline incision of anterior vaginal wall in presence of urethral catheter. E. Paraurethral spaces blunt dissection (at 10 o’clock position) until the descending ischiopubic ramus was reached. F. Hyperextention of the STM T pocket by the forceps. G. Hyperextention of the T pocket of STM by the forceps at other end of the STM tape. J. The T-pocket was then extended inside the internal obturator muscles by opening the forceps. The forceps were then closed and pulled off the vagina. K. Visualization of suburethral tape untwisted before closure of the wound. L. Closure of vaginal incision by vicryl 3/0 interrupted suture. H. By hyperextension and closure of the forceps the STM was folded into surgical forceps by placing the forceps inside the T- Pocket followed by opening and closing the forceps. I. Forceps with the folded mesh was introduced by a controlled push at 45° from the horizontal plane in the previous dissected paraurethral space until a “crack” was felt that signified the penetration of the internal obturator fascia. D. Paraurethral space blunt dissection at 2 o’clock position until the descending ischiopubic ramus was reached. A. Polypropylene mesh 30 x 30 cm that will be tailored as tapes. B. Polypropylene strips or tapes (surgical tailored mesh) each one 1 cm x 30 cm prepared for package and sterilization by plasma machine. – dissection was made bilaterally to reach the ischiopubic ramus; – the T-pocket shaped mesh was then folded into surgi- cal forceps, which were introduced at 45 degrees to the dissected paraurethral space until the internal obtura- tor fascia was penetrated; – the surgeon opened the forceps to extend the T-pocket shaped mesh and removed the pulling sutures after full positioning; – a 3-0 vicryl suture was used to close the vaginal incisions in an interrupted fashion. The vagina was packed with a povidone-iodine-soaked pack, and the urethral catheter was connected to closed-bag drainage (Figure 2). Archivio Italiano di Urologia e Andrologia 2023; 95, 2 Eman Ali, Salah E. Shebl, Sayeda Ibrahim 81 Women in both groups received routine postoperative care, and the vaginal pack and catheter were removed 12 hours after the operation in uneventful cases. Follow-up and study's outcomes All women were followed biweekly in the first postoper- ative month, then every month for three months. The fol- low-up visits consist of subjective assessment of SUI symptoms through the SUI questionnaire and urodynam- ic studies. The surgical outcome was categorized accord- ing to the questionnaire and abdominal leak point pressures (ALLP) into: success, in which there is no urinary leakage with stress and patient's satisfaction; improve; in which there was leakage with severe exertion only; and failed, in which there is a persistent leakage and patient's dissatis- faction. Statistical analysis Retrieved data were summarized and processed with IBM SPSS statistical software (version 25). Descriptive statis- tics were used to describe continuous and categorical data, respectively. The hypothesis of significant difference between the techniques regarding postoperative out- comes and complications was tested using the Chi-square test, with Fisher exact whenever needed. The association between technique and continuous data was tested using the Mann-Whitney test. P-value < 0.05 was regarded as statistically significant. RESULTS A total of 60 women were included in the present study. The mean age of the standard and SIMS groups was 45.6 ± 7.9 and 42.3 ± 6.6 years old, respectively. None of the patients was nulliparous. The mean number of deliveries in the standard group was 3.6±1.7, compared to 3.9 ± 1.1 deliveries in the SIMS group. Two patients had cesarean section (CS) in addition to their vaginal deliveries. Seven cases had associated preopera- tive urinary tract infection. Almost 90% of the patients had no previous surgery, three patients (5%) underwent an abdominal hysterectomy, and three patients (5%) underwent previous vaginal prolapse repair surgery. Nine (30%) patients had grade I cystocele in the standard group, and six (20%) patients had grade II cystocele. Five (16.6%) patients had grade I cys- tocele on examination in the SIMS group. The mean duration of symptoms was 2.73 ± 1.36 years (range 1-5 years). Four cases only (6.67%) in both groups had an ALPP less than 50 ml, which indicate intrinsic sphincteric deficiency. The pre- operative urodynamic studies showed a mean bladder capacity of 382.76 ± 34.26 ml. No patient had detrusor overactivity or significant residual urine pre- operatively (Table 1). The mean operative time was significantly longer in the standard TOT group (17.0 ± 2.9 min) compared to the SIMS group (10.7 ± 1.8 min). The mean bleeding rate was significantly higher in the standard TOT group (87.6 ± 10.6 cc) compared to the SIMS group (60.0 ± 8.1 cc). One case (3.33%) had bladder injury in the SIMS group, which needed cystoscopy revealing a small bladder injury that was repaired immediately by vicryl 4/0 in two layers. There was no urethral injury in both groups. None of the studied patients developed intraoperative vaginal wall laceration (Table 2). Concerning early complications, re-catheterisation was not needed in any patient as there was no retention of urine or significant residual urine postoperatively. The incidence of postoperative urinary tract infection (UTI) was 10% and was treated medically according to culture and sensitivity. Three patients (two in the standard TOT and one in the SIMS group) developed a vaginal dis- charge. Postoperative wound infection was not found in any cases. None of the studied patients developed urine retention. In terms of late complications, transient thigh pain occurs in 12 cases (40%) of the standard TOT and no cases in the SIMS group (p < 0.001). After three months from operation, vaginal discharge was reported in two cases (6.7%) treated with the appropriate antibiotics, antifungals, and frequent vaginal douches. Five cases (20%) had urinary tract infection which was treated med- ically according to culture and sensitivity. Dyspareunia, vaginal erosions and de novo urgency were not reported during postoperative follow up (Table 2). After three months, there was no significant statistical dif- ference between the result of the two groups as regard to cure or improvement rate, wherein the standard TOT group, 27 cases (90%) and three cases (10%) were suc- ceeded and improved, respectively, compared to 28 cases (93.33%) and two cases (6.66%) in the SIMS group. No Table 1. Preoperative data of both groups. Variables STM standard TOT STM SIMS P-value N = 30 % N = 30 % Age (years) Mean ± SD 45.6 ± 7.9 42.3 ± 6.6 P = 0.086 Delivery Normal vaginal delivery 3.6 ± 1.7 3.9 ± 1.1 P = 0.561 Cesarean section 0.07 ± 0.25 0.03 ± 0.18 Menopausal status Pre menopause 20 (66.7%) 24 (80%) P = 0.243 Post menopause 10 (33.3%) 6 (20%) Surgical history Patients with no previous surgery 25 (83.3%) 29 (96.7%) P = 0.163 Previous vaginal prolapse repair surgery 3 (10%) 0 (0%) Previous abdominal hysterectomy 2 (6.7%) 1 (3.3%) Per vaginal examination Normal 15 (50%) 25 (83.3%) P = 0.008* Mild cystocele 9 (30%) 5 (16.7%) Moderate cystocele 6 (20%) 0 (0%) Severity of preoperative incontinence rate Mild (0-1 pad/day) 2 (6.7%) 3 (10%) P = 0.707 Moderate (2-3 pad/day) 14 (46.7%) 16 (53.3%) Severe (4-5 or more pad/day) 14 (46.7%) 11 (36.7%) ALLP < 50 ml 2 (6.66%) 2 (6.66%) 51-100 ml 12 (40%) 16 (53.33%) 101-150 ml 14 (46.66%) 12 (40%) 151-200 ml 2 (6.66%) 0 (0%) Archivio Italiano di Urologia e Andrologia 2023; 95, 2 82 Single-incision needleless mini-sling technique for female stress urinary incontinence failed cases were reported in both groups (p = 0.64) (Figure 3). Likewise, there was no significant difference between the two groups regarding patients' satisfaction rate. In the standard TOT group, 23 cases (76.7%) were very satisfied, compared to 22 cases (73.3%) in the SIMS group (p = 1.00). DISCUSSION In this study, we included two comparable groups of women with no significant differences in terms of age, BMI, parity, or menopausal status. In addition, there were no significant differences in results of pelvic examination or cough stress test between women of both groups before surgery. However, in terms of operative time, STM SIMS needed a mean operative time of 10.7 minutes, which was significantly less than the mean operative time (17 minutes) needed by the STM standard TOT proce- dure. Similarly, Hasan et al., demonstrated that the mean operative time of the mini-sling procedure was 8.3 min- utes compared to 16.5 minutes in the standard TOT pro- cedure (5). The mean operative time of the single incision TOT procedure was nine minutes and seven minutes in the studies conducted by Cabrera et al. (19) and Navazo et al. (20), respectively. Regarding intraoperative blood loss, our findings showed that the standard TOT was associated with significantly higher procedure-related blood loss compared to STM SIMS. In the Hasan et al. study, single incision TOT patients had a lower average than regular TOT patients (51.5 vs. 123.1 ml), respectively (5). According to a study done by Magon and Chopra on 51 individuals, the average volume of blood loss in the conventional TOT was 78.76 ml (21). Dobson et al. showed that the blood loss was more than 100 ml in 71% of cases (22). Moore et al. reported an average intraoperative blood loss of 57 ± 22 ml in the stan- dard TOT and 36 ml in the single incision TOT (23). In our study, the early postoperative complications were more common in the standard TOT, including groin pain, UTI, and vaginal infection. However, intraoperative com- plications and late postoperative complications were sim- ilar in both groups. Likewise, in the Hasan et al. trial, there was no significant difference in iatrogenic organ injury and postoperative complications between the two groups (5). When Amati et al. completed their investigation, they found that just one patient in each group had a bladder injury that could be attributed to the simultaneous sur- gery. In the group of standard TOT, there was one case (3.3%) catheterized for two weeks due to intraoperative bladder injury (24). Navazo et al. reported a mean catheterization time of 2.02 days (20). Cabrera et al. men- tioned that after the standard TOT, the mean catheteriza- tion time was 1.52 days in 5 patients with acute retention (19). Retention that needed catheterization for more than 24 hours following routine TOT resolved spontaneously in less than two days in one case described by Magon and Chopra (21). It has been found that the prevalence of dys- pareunia after SIMS ranges from 3 to 8% (Richter et al.) (25). In our study, it was observed that neither group suf- fered from urge incontinence, voiding difficulties, urine retention, urethral or bladder erosions, or dyspareunia. According to Karakeçi et al., postoperative dyspareunia occurred in 21% of patients in the midurethral sling (MUS) group and 20% of patients in the SIMS group (26). According to several clinical trials, the percentage of void- ing problems after SIMS ranged from zero to eight percent (27, 29). The proportion of patients experiencing pain after the procedure was reported to reach up to 15.5% (25). Although the groin and leg pain spontaneously resolved within a few weeks in many cases, it may be pro- longed in some patients. During the short mid-term fol- low-up, Karakeçi et al. preferred the SIMS technique since it caused less groin pain (26). Also, SIMS was preferred and recommended by more incontinence-suffering women (30, 31). SIMS has reduced complication rates due to little retropubic dissection and the absence of blind needle and mesh path in the groin region (26). Patients were released from the hospital within 24 hours following surgery in our study with no significant differ- ences in postoperative hospital stays between the two techniques. In the study of Magon and Chopra, the aver- age hospitalization time was 1.6 days; 45.8% of patients were released within 24 hours after surgery, 50.88% were discharged between 24 and 72 hours after surgery, and only 3.4% of patients had to remain in the hospital for more than three days because of intraoperative complica- tions (21). Postoperative hospital stay was not signifi- cantly different between the two procedure (standard TOT: 2.95 days and single-incision TOT: 2.65 days), with a mean of 1.04 days including both procedures when there were no concomitant operations and of 2.65 days when there were concomitant operations (24). STM standard TOT patients had an objective cure rate of 90% after three months, with a 10% improvement and no failed cases reported, while STM SIMS patients had an objective cure rate of 93.33% after three months, with a 6.66% improvement and no failed cases reported. Cabrera et al. studied 230 women who had undergone single incision TOT and found that 86% of them were Table 2. Operative time and complication of both groups. Variables STM standard TOT STM SIMS P-value N = 30 % N = 30 % Operative time (minutes) P = 0.000* • 8-11 0 0.0 20 66.7 • 12-18 22 73.3 10 33.3 • 19-25 8 26.7 0 0.0 Operative time (minutes), Mean ± Sd 17.0 ± 2.9 10.7 ± 1.8 P = 0.000* Intra-operative complications P = 0.313 Bladder injury 1 (3.3%) 0 Bleeding rate (CC), Mean ± SD 87.6 ± 10.6 60.0 ± 8.1 P = 0.000* Vaginal wall laceration 0 0 Early postoperative complications P = 0.000* • Groin pain 12 (40%) 0 (0%) • Urinary tract infection 2 (6.7%) 1 (3.3%) • Vaginal infection 2 (6.7%) 1 (3.3%) • Urine retention 0 (0%) 0 (0%) Late postoperative complications P = 0.554 • Mesh erosions 0 0 • De novo urgency 0 0 • Dyspareunia 0 0 • Vaginal discharge 1 (3.34%) 1 (3.34%) • Urinary tract infection 3 (10%) 2 (6.7%) Archivio Italiano di Urologia e Andrologia 2023; 95, 2 Eman Ali, Salah E. Shebl, Sayeda Ibrahim 83 objectively cured after a year, with 6% showing improve- ment and 8% being classified as failures (19), while Navazo et al. studied 120 women who had undergone single incision TOT and found that 84% were objectively cured after a year, with 8% showing improvement (20). There were no failed cases in the initial case series per- formed by Delorme et al. on 32 women who had under- gone the conventional TOT and had a cure rate of 90.6% at one year (32). At one year following the standard TOT operation, the objective cure rate was 88-92% and the subjective cure rate was 68-90%, according to published studies (33). In conclusion, our study showed that SIMS was not infe- rior to standard TOT. STM SIMS is a mini-invasive, rela- tively safe, reproducible, and economically effective sur- gical procedure for the treatment of female stress urinary incontinence. The STM for SIMS was easy to insert in a short time operation. 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Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape). A new minimally invasive method in the treatment of urinary incontinence in women. Progr Urol. 2003; 13:656-659. 33. Deval B, Ferchaux J, Berry R, et al. Objective and subjective cure rates after trans-obturator tape (OBTAPE) treatment of female uri- nary incontinence. Eur Urol. 2006 49:373-377. Correspondence Salah E. Shebl, MD (Corresponding Author) salahshebl@yahoo.com salahshebl@azhar.edu.eg Urology Department, Faculty of Medicine for Girls Al-Azhar University, Al Zahraa University Hospital, Al-Azhar University, Abbasia, Cairo, Egypt Sayeda Ibrahim, MD Soso_uro@yahoo.com Eman Aly, MD dr.emanaly200@gmil.com Urology Department, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt Conflict of interest: The authors declare no potential conflict of interest.