FEMALE UROLOGY The Effect of Valsalva Leak Point Pressure on Outcomes of the Needleless ®System in Female Stress Urinary Incontinence Seung Bum Han, Joon Chul Kim, Dong Hwan Lee, Hyo Sin Kim, Jun Sung Koh, Won Sok Hur, Kang Jun Cho* Purpose: This study aimed to investigate the effects of preoperative Valsalva leak point pressure (VLPP) on the outcomes of the single-incision midurethral sling procedure (Needleless® System) in female stress urinary incon- tinence (SUI). Materials and Methods: We evaluated 112 patients who underwent midurethral sling placement for SUI using the Needleless® System. Patients were divided into two groups according to their preoperative VLPP values: VLPP > 90 cmH 2 O (group 1) and VLPP 60-90 cmH2O (group 2). After the postoperative period, SUI status and satisfaction were compared between the two groups. Subjective cure was defined as the absence of any episodes of urinary incontinence associated with conditions that increase intra-abdominal pressure in daily life. Treatment satisfaction was analyzed according to patient responses as ‘satisfied’, ‘neutral’, and ‘dissatisfied’. Postoperative other lower urinary tract symptoms except SUI were compared between the two groups too. Results: There were no significant differences in age, body weight, and urodynamic parameters (except VLPP) between the two groups. The mean VLPPs were 105.9 ± 12.3 cmH 2 O (range, 93.6–118.2 cmH2O) in group 1 and 75.4 ± 10.5 cmH2O (range, 65–85.9 cmH2O) in group 2. The overall subjective cure rates were 65.0% in group 1 and 62.5% in group 2 (P = .744). The overall satisfaction rates were 58.8% in group 1 and 68.8% in group 2 (P = .600). Complication rates did not differ between the two groups. Conclusion: When stratified as > 90 cmH2O or ≤ 90 cmH2O, preoperative VLPP did not affect Needleless ® Sys- tem outcomes in female SUI patients. Keywords: urinary incontinence; stress; surgery; treatment outcome; urodynamics; female; suburethral slings. INTRODUCTION Midurethral slings that utilize synthetic polypro-pylene monofilament mesh have been estab- lished to be safe and effective in the treatment of female stress urinary incontinence (SUI). This treatment strat- egy is based on Petros and Ulmsten’s(1) suggestion that the main pathophysiology of SUI involves weakening of the pubourethral ligaments and the impairment of midurethral function and anterior urethral wall support. Midurethral sling techniques have progressed rapidly, and they can be classified into three generations, with retropubic transvaginal tape (TVT) representing the first generation, and transobturator tape (TOT) rep- resenting the second generation. The third generation technique is the single-incision mini-sling (SIMS), which utilizes a shorter sling and a single vaginal inci- sion to minimize morbidity by avoiding blind passage in the retropubic space or obturator foramen. Although the SIMS offers a shorter operative time and a lower risk of postoperative pain, debate remains over its clin- ical efficacy compared to standard midurethral slings. A meta-analysis by Mostafa and colleagues(2) found no evidence of significant differences in cure rate between SIMS and standard midurethral slings at a mean fol- low-up of 18 months, excluding the TVT-Secure (Gy- necare, Sommerville, NJ, USA). The TVT-Secure was inferior to standard midurethral slings and has already been withdrawn from clinical use. While there has been insufficient evidence to reveal a difference in outcome between SIMS and standard midurethral slings, SIMS has been considered inferior to standard midurethral slings.(3,4) Various fixation mechanisms and preopera- tive risk factors may influence the outcomes of SIMS placement. Adequate patient selection would be benefi- cial in situations in which the efficacy of SIMS is uncer- tain. Valsalva leak point pressure (VLPP), an objective parameter of SUI severity, is a risk factor for the failure of surgical treatment. Patients with a low VLPP in the preoperative urodynamic study (UDS) are considered to have a greater risk of treatment failure. Some studies found that patients with a low VLPP had a lower sub- jective cure rate after TVT, but there was no significant difference in outcomes after TOT.(5,6) However, there is a lack of data regarding the relationship between VLPP and SIMS outcomes. We therefore investigated the effects of preoperative VLPP on SIMS outcomes using the Needleless® System (Neomedic International, Spain) in female SUI. MATERIALS AND METHODS Study Subjects After Institutional Review Board approval, we retro- Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea *Department of Urology, The Catholic University of Korea, Bucheon St. Mary`s Hospital, 327 Sosa-Ro, Wonmi-gu, Bucheon-city, Gyeonggi-do, 420-717, Korea. Tel: +82 32 3407730. Fax: +82 32 3402124. E-mail: gift99@catholic.ac.kr. Received April 2015 & Accepted July 2015 Female Urology 2251 spectively reviewed the clinical data of women who un- derwent SIMS using the Needleless® System for SUI in two centers from March 2010 to August 2012 and could be followed up by telephone interview. Those who pre- viously underwent other surgeries for SUI, had neuro- logically caused incontinence, or had stage 3 or greater pelvic organ prolapse were excluded. Techniques of anti-incontinence surgery in patients without exclusion criteria were chosen by surgeon’s preference in our in- stitute. Patients were divided into two groups according to their preoperative VLPP values: VLPP > 90 cmH2O (group 1), VLPP 60-90 cmH 2 O (group 2). Evaluations All the women underwent clinical evaluations, includ- ing complete history taking, physical examination, and UDS. UDS was performed with a 6-French (F) dual-lu- men vesical catheter and a 12-F rectal balloon catheter. The bladder was filled with 30–50 mL/min saline with the patient in the sitting position. Patients were asked to void prior to the examination, at which point the maxi- mum flow rate in the sitting position, voiding volume, and postvoid residual urine volume were recorded. Dur- ing bladder filling, the patients were simply instructed to report their sensations to the examiner. Total bladder capacity was recorded during filling cystometry. A ure- thral pressure profile was performed, and the detrusor pressure at the maximum flow rate in the voiding phase and the maximum urethral closure pressure were re- corded. With the subject seated after 150 mL of filling, VLPP was determined by asking the subject to perform a Valsalva maneuver until urine loss was directly ob- served. If there was no leakage at this volume, the test was repeated after each additional 50 mL of filling. The lowest measured VLPP was recorded. Surgical Technique Placement of the midurethral sling (Needleless® Sys- tem) was performed by one of two experienced urol- ogists (JCK, DHL) under spinal or general anesthesia. The intervention consisted of placing a polypropylene monofilament mesh measuring 114 mm in length and 12 mm in width under the midurethra; a pocket posi- tioning system was located in the lateral sides of the mesh, anchoring the sling. The patient was positioned in the lithotomy position, and a 16 F Foley catheter was inserted into the bladder for drainage and identifica- tion of the bladder neck. A longitudinal 2 cm incision was made in the anterior vaginal wall at the level of the midurethra. Lateral to this incision, the para-ure- thral spaces were dissected bluntly at 2 and 10 o’clock positions to easily accept the fully extended mesh, but only up to the descending ramus of the pubic bone. A pair of surgical forceps was then introduced inside the pocket positioning system at the edge of the mesh. We hyperextended the jaws of the forceps and closed them to create an arrow with the mesh. The mesh was then introduced through the dissected para-urethral space. We continued pushing the forceps in the 10 o’clock di- rection, perforating the urogenital diaphragm and into the internal obturator muscle. The forceps were opened widely to extend the pocket inside the muscle. We then withdrew the forceps, semi-closing them. To control the penetration of the tip of the forceps and the mesh, the surgeon could hold the central portion of the mesh by means of a blue centering suture affixed to the middle of the mesh for this purpose. The process was repeated on the contralateral side towards the 2 o’clock direc- tion. Once the sling was placed, it could be adjusted to further support the urethra by introducing the tip of the forceps into the pocket positioning system and push- ing the tip of the mesh up to the desired support level. To reduce the mesh urethral support level, the surgeon could pull the blue centering suture on the mesh. After achieving proper positioning, the blue centering suture was removed from the mesh with a single cut on one side of the suture while maintaining traction on the su- ture. Finally, the vaginal incision was closed using 2-0 rapidly absorbable sutures in a running fashion. All pa- tients were discharged on the same day after voiding. Outcome Measures After the postoperative period, SUI status and treatment satisfaction were compared between the two groups. Subjective patient outcomes were defined as follows: “cure” was defined as the absence of any episodes of urinary incontinence associated with conditions that in- crease intra-abdominal pressure in daily life, “improve- ment” was defined as reduced frequency and amount of urine leakage, and all other outcomes were regarded as “failure”. Treatment satisfaction was analyzed accord- ing to patient responses as ‘satisfied’, ‘neutral’, and ‘dissatisfied’. Other lower urinary tract symptoms new- Table 1. Comparison of preoperative clinical characteristics and urodynamic parameters between group 1 and group 2. Variables Group 1 (n = 80) Group 2 (n = 32) P Value Age (years) 54.4 ± 6.9 54.5 ± 8.9 .748 Body weight (kg) 61.9 ± 9.8 58.4 ± 2.8 .274 Mixed UI 33 (41.2) 12 (37.5) .715 Qmax (mL/s) 20.9 ± 7.5 22.5 ± 7.2 .550 PVR (mL) 28.2 ± 35.1 30.0 ± 27.0 .510 VLPP (cmH 2 O) 105.9 ± 12.3 75.4 ± 10.5 <.001 PdetQmax (cmH 2 O) 31.7 ± 15.9 21.3 ± 8.3 .095 MUCP (cmH 2 O) 60.0 ± 25.9 49.1 ± 11.4 .364 CMG bladder capacity (mL) 329.8 ± 64.1 311.6 ± 60.2 .530 Abbreviations: UI, urinary incontinence; Qmax, maximum urinary flow rate; PVR, postvoid residual volume; Pdet Qmax, detrusor pressure on maxi- mumflow; MUCP, maximum urethral closure pressure; VLPP, Valsalva leak point pressure; CMG, cystometrography. Data are presented as mean ± standard deviation or as no. (%). Vol 12 No 04 July-August 2015 2252 Effect of VLPP on Outcome of Needleless in SUI-Han et al. ly detected during follow-up were recorded and com- pared between the two groups. Urgency incontinence was evaluated with urinary sensation scale. Statistical Analysis All statistical analyses were carried out using IBM Sta- tistical Package for the Social Science (SPSS) version 20.0 (IBM Corp., Armonk, NY, USA). Continuous var- iables were reported as the mean ± standard deviation and categorical variables were expressed as frequencies with percentages. Continuous variables were evaluated using Student t-test. Categorical variables were evalu- ated with the Chi-Square test. A P value < .05 was con- sidered statistically significant. RESULTS A total of 112 patients were enrolled in the study. Ta- ble 1 presents the preoperative clinical and urodynamic characteristics of group1 (n = 80) and group 2 (n = 32). The mean follow-up was 28.1 ± 4.9 months (range 25– 40) for group 1 and 27.8 ± 3.5 months (range 24–36) for group 2. No significant differences were found between the two groups in terms of age, body weight, mixed uri- nary incontinence rates and urodynamic parameters (ex- cept VLPP). The mean VLPP values were 105.9 ± 12.3 cmH2O (range, 93.6-118.2 cm H2O) in group 1 and 75.4 ± 10.5 cm H2O (range, 65-85.9 cm H2O) in group 2. The overall subjective cure rates were 65.0% in group 1 and 62.5% in group 2 (P = .744). The overall satisfaction rates were 58.8% in group 1 and 68.8% in group 2 (P = .600) (Table 2). Twenty-five patients (31.3%) in group 1 and nine patients (28.1%) in group 2 complained of voiding symptoms, such as a weak stream, straining to void, and intermittency, but there were no severe void- ing difficulties requiring urethral catheterization (P = .745). Overall 45 (40.1%) patients had mixed urinary incontinence preoperatively, whereas, 29 (25.9%) pa- tients had urge incontinence at follow up for more than 24 months. Five patients (6.2%) in group 1 and six pa- tients (18.8%) in group 2 complained of postoperative de novo urgency incontinence (P = .073). There was not any other early or late postoperative complication such as vaginal tape erosions and urinary tract infection related with anti-incontinence surgery. DISCUSSION We found that preoperative VLPP did not affect cure rate, satisfaction, or postoperative de novo urinary symptoms after SIMS using the Needleless® System in female SUI patients with a preoperative VLPP > 60 cmH 2 O. A VLPP ≤ 60 cmH2O in SUI is suggestive of an intrinsic sphincter deficiency etiology.(7) Some au- thors demonstrated a correlation between VLPP and risk factors for standard midurethral sling success(5,8) while others have not.(6,9) The VLPP threshold reported in the literature is generally 60 cmH 2 O. Some studies with varying VLPP thresholds used VLPP values of 60 and 90cmH2O. (6,10) In a study seeking to identify pre- operative factors affecting the SIMS cure rate, a VLPP < 60 cmH2O was associated with a lower cure rate for the TVT-Secure (11) and severe incontinence was a risk factor for failure of the Mini-Arc (American Medical Systems, Minnetonka, MN, USA).(12) A previous study of Needleless® System outcomes by Amatand col- leagues(13) did not include patients with intrinsic sphinc- ter deficiency, defined as a VLPP < 60 cmH2O and the absence of urethral hypermobility. Although we did not propose the exclusion of patients with a VLPP < 60 cm- H2O initially, all patients enrolled in our study had VLPP values ≥ 60 cmH2O. This indicates that surgeons tend to avoid using SIMS in patients with intrinsic sphincter deficiency. Thus, we used a VLPP of 90 cmH 2 O as the threshold for investigating the effect of preoperative VLPP on Needleless® System outcomes. A VLPP ≥ 90 cmH2O is usually not associated with intrinsic sphinc- ter damage and is related to urethral hypermobility, while a VLPP of 60-90 cmH2O indicates the possible coexistence of intrinsic sphincter damage and urethral hypermobility.(14) Agarwal and colleagues(15) reported no significant differences in quality of life and inconti- nence assessment tools at both 6 and 12 months postop- eratively when comparing TOT outcomes by stratifying preoperative VLPP as 60-90 or > 90 cmH2O. Howev- er, SIMS procedures such as the Needleless® System have basic anchoring mechanisms different from those of standard midurethral sling procedures such as TOT. SIMSs have a shorter trajectory of mesh insertion and need to be soundly anchored to the obturator internus muscle with a strong post-insertion pullout force.(2) We hypothesized that these different anchoring mecha- nisms could influence SIMS outcomes when compar- ing patients with a preoperative VLPP of 60-90 versus > 90 cmH2O. However, we did not find any significant differences in Needleless® System cure rate between the two groups. Rather, the treatment satisfaction rate seemed to be higher when the VLPP was lower (68.8% vs. 58.8%), although the difference of satisfaction rate was not significant. Patients with a lower VLPP, which is associated with more severe SUI, were more satisfied by a relatively minor improvement of their symptoms through surgical treatment. In this study, the total cure rate and total satisfaction rate for the overall study cohort more than 24 months after the Needleless® System procedure were 64.3% (72/112) and 61.6% (69/112), respectively. Amat and Table 2. Comparison of subjective outcomes between group 1 and group 2. Variables Group 1 (n = 80) Group 2 (n = 32) P Value Cured 52 (65.0) 20 (62.5) .744 Improved 22 (27.5) 9 (28.1) Failed 6 (7.5) 3 (9.4) Satisfied 47 (58.8) 22(68.8) .600 Neutral 25 (31.2)) 6 (18.8) Dissatisfied 8 (10.0) 4 (12.4) All data are presented as no. (%). Female Urology 2253 Effect of VLPP on Outcome of Needleless in SUI-Han et al. Martinez Franco (13,16) reported outcomes for SUI wom- en who underwent the Needleless® System procedure. In their study, 87.5% of patients were cured, 39.7% were very satisfied, and 53.4% of patients were satis- fied at 12 months after treatment. In addition, 84.7% of patients were cured, 40.5% were very satisfied, and 52.7% were satisfied at 36 months after treatment. The outcomes for the Needleless® System were not differ- ent to those of the TVT-O. The differences in cure and satisfaction rates between our study and previously re- ported studies may be due to these studies’ exclusion patients who had symptoms of urgency before surgery that persisted after surgery. Among the most troublesome outcomes following an- ti-incontinence surgery is the development of voiding dysfunction. A long-term study of the Needleless® Sys- tem showed that 8.4% of patients experienced de novo urgency and 0.8% experienced voiding difficulty.(16) A study of SIMS utilizing the Ophira Mini Sling (Prome- don, Cordoba, Argentina) found that 7.3% of patients experienced de novo urgency and 3.2% experienced voiding difficulty.(17) In our study, 9.8% (11/112) of pa- tients experienced de novo urgency and 30.3% (34/112) experienced voiding symptoms, and there were no sig- nificant differences in de novo voiding dysfunction be- tween groups 1 and 2. Although urgency incontinence prior surgery would influence the outcomes of anti-in- continence surgery, overactive bladder symptoms could decrease significantly by surgical treatment for SUI.(18) Our study showed the similar results. Our study has some limitations. First, this study was a retrospective study and the outcomes were entirely based on patient self-reports of incontinence rather than objective outcomes. This had a relatively small sam- ple size that did not have statistical power sufficient to show the relationship of VLPP with outcome of SIMS. Further prospective research with adequate power and improved design are needed to provide more informa- tion. In addition, there is a lack of consensus regarding the specific threshold of VLPP that correlates with the surgical outcomes of SIMS. We acknowledge that se- lecting slightly different VLPP thresholds could result in slightly different outcomes. CONCLUSIONS Although we could not identify preoperative factors for adequate SIMS patient selection, preoperative VLPP stratified as 60-90 cmH 2 O or > 90 cmH 2 O did not affect outcomes after SIMS performed using the Needleless® System. Further studies are necessary to confirm these data and to identify preoperative factors predicting the outcome of SIMS. CONFLICT OF INTEREST None declared. REFERENCES 1. Petros PE, Ulmsten UI. 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