Novel technique of laparoscopic mid-urethral autologous rectus fascial sling for stress urinary incontinence.

Serious concerns have been raised over the safety of vaginal mesh tapes for stress urinary incontinence (SUI). Autologous rectus fascial sling and the more recent 'sling on a string' through a laparotomy are gaining popularity as native tissue options for SUI. We describe a novel technique of laparoscopic mid-urethral autologous rectus fascial sling for SUI. Ten patients underwent this new technique safely. At 12 months, all patients reported cure of SUI with normal voiding. The advantages of this technique include the minimal access approach, introduction of the sutures under laparoscopic guidance, and avoidance of over-tightening of the sling.

Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes.

PURPOSE: To assess noninferiority of the safety and effectiveness of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic slings through 36 months in a prospective, longitudinal, nonrandomized US Food and Drug Administration (FDA) 522 cohort study. MATERIALS AND METHODS: Adult females with confirmed predominant stress urinary incontinence (UI) through cough stress test (CST) or urodynamics and failed two noninvasive incontinence therapies. Effectiveness endpoints included objective dryness, negative CST, adverse events, and revision/resurgery through 36 months. The primary effectiveness endpoint was reduction from baseline in 24-h pad weight of ≥50% at 6 months, as requested by the FDA, and is included as a study point in this paper. Primary safety endpoint was rate of related serious adverse events (SAE) through 36 months. Noninferiority margins of 15% and 10% were prespecified for the effectiveness and safety endpoints. Due to the observational nature of the cohort study, a propensity methodology was conducted to assess the effect of potential confounding variables on the primary endpoints between groups. RESULTS: Three hundred fifty-five women underwent the sling procedure (n = 184 Altis; n = 171 Comparator). One hundred fourty (76%) Altis subjects and 101 (59%) Comparator subjects completed follow-up through 36 months. At 36 months, for the effectiveness endpoint, the difference in proportions of -0.005 for Altis versus Comparator (95% confidence interval [CI]: -0.102 to 0.092) was statistically significant (p = 0.002), supporting the hypothesis that Altis is noninferior to Comparator. Furthermore, both groups demonstrated high objective efficacy; in the Altis arm n = 99 (81.8%) subjects were a success, and in the Comparator arm, n = 79 (82.3%) subjects were a success. Additionally, regarding the CST, Altis was found to be noninferior to the Comparator at every study visit, and the rate of negative CST remained above 80% for both groups (p < 0.001). At 36 months, Altis (n = 2; 1.1%) and Comparator (n = 4; 2.3%) subjects experienced a device and/or procedure-related SAE. The difference in proportions of 0.013 for Altis versus Comparator (95% CI: -0.023 to 0.048) was statistically significant (p < 0.001), demonstrating that Altis is noninferior to Comparator with respect to the primary safety endpoint throughout the study. There were 62 (36.3%) retropubic midurethral slings (RMUS), 96 (56.1%) transobturator midurethral slings (TMUS), and 13 (7.6%) SIS slings in the Comparator group. For the 36 month effectiveness endpoint, assessing the noninferiority of Altis versus RMUS and Altis versus TMUS, 99 (81.8%) Altis and 37 (90.2%) RMUS were a success, trending toward statistical significance, however, it cannot be determined to be noninferior (p = 0.092). Ninty-nine (81.8%) Altis and 33 (71.7%) TMUS were a success; this was statistically significant (p < 0.001), demonstrating Altis was noninferior to TMUS. Rates of negative CST were 122 (87.1%) Altis, 40 (93.0%) RMUS (p < 0.001), and 44 (91.7%) TMUS (p < 0.001). CST demonstrated that Altis was noninferior to RMUS and Altis was noninferior to TMUS at 36 months. CONCLUSION: Altis single-incision sling was noninferior to standard midurethral sling for treatment of stress UI, throughout the study and at 36 months. Furthermore, adverse event rates were low.

[Surgical treatment of urinary incontinence in geriatric patients].

INTRODUCTION: Recently, there has been a steady upward trend in life expectancy, so it is extremely important to remember some of the features of the body associated specifically with aging. Thus, an important topic for discussion is the issue of ensuring the quality of life of an elderly woman. The prevalence of urinary incontinence in patients of the older age group leads to significant restrictions in their social life. Surgical treatment using general and regional anesthesia has significant contraindications due to age and comorbidities. In this regard, in some cases, local anesthesia is the method of choice of anesthesia in this category of patients. PURPOSE OF THE STUDY: Evaluation of the possibility of using local anesthesia in the surgical treatment of stress urinary incontinence in geriatric patients. MATERIALS AND METHODS: We analyzed the results of surgical treatment of stress urinary incontinence in 42 patients. The mean age of the patients was 78+/-4 years. All patients were treated for urinary incontinence using mini loops under local anesthesia. Pre- and postoperative examination included vaginal examination in mirrors, cough test, cystoscopy (if indicated), uroflowmetry, ultrasound examination of the pelvic organs and bladder, bacterial culture of urine with determination of sensitivity to antibiotics. Taking into account the advanced age of the patients, the protocol of the preoperative examination included the obligatory performance of ultrasound Doppler examination of the veins of the lower extremities and echocardiography. RESULTS: The duration of the operation averaged 22+/-5 minutes. Complications requiring a change in the course of the operation were not registered during the operation. 1 month after the operation, at the control examination, the cough test was negative in 40 (95,2%) patients. 2 (4,8%) had a positive cough test. After 6 months, out of 40 (100%) successfully operated patients, 4 (9,52%) had urine leakage during the cough test. The maximum follow-up period for patients was 12 months. Out of 40 (100%) patients with a negative cough test after surgery, it was possible to track the long-term results of treatment only in 33 (82,5%) patients. After evaluating the results of 33 (100%) operated patients after 12 months, it was found that in 30 (90,9%) patients the symptoms of urinary incontinence were completely absent, in 3 (9,09%) there was a recurrence of urinary incontinence. CONCLUSIONS: Surgical treatment of stress urinary incontinence using a synthetic loop under local anesthesia is effective and safe in geriatric patients.

A new promising approach to urodynamic stress urinary incontinence care can help menopausal women.

Introduction: The goal of this study is to evaluate the effectiveness of single-incision mini-sling in the surgical treatment of postmenopausal urodynamic stress urinary incontinence (SUI) compared to the standard trans-obturator mid-urethral sling. Material and methods: This prospective study was carried out in two tertiary centres; Al-Azhar University Maternity & Urology Hospitals. A total of 120 postmenopausal women with urodynamic SUI were randomized to undergo either single-incision mini-sling (n = 60) or standard trans-obturator mid-urethral sling procedure (n = 60) from May 2019 until Oct 2021. Main outcome measures: efficacy was evaluated utilizing objective cure rate (cough stress test) and subjective cure rate (Sandvik incontinence severity index and International Consultations on Incontinence Questionnaire - Short Form), intraoperative and postoperative complications, and postoperative pain (using a visual analogue scale). Results: The single-incision mini-sling (SIMS) and transobturator tape (TOT) groups had no statistically significant difference in subjective and objective cure rates (p > 0.05). Compared with the transvaginal tape O group, patients in the SIMS group had significantly less postoperative pain, shorter operative duration, and less intraoperative blood loss (all p-values < 0.05). No significant difference in perioperative complications was observed between both groups. Conclusions: Single-incision mini-sling was superior to TOT in postmenopausal as SIMS is of similar effectiveness, more safe and minimally invasive with earlier ambulance.

Comparison of Two Single-Incision Mini-Slings for the Treatment of Incontinence.

INTRODUCTION: This study aimed to compare the safety and efficacy of 2 single-incision mini-sling (SIMS) systems with different designs of anchoring mechanism. METHODS: The records of patients who have been operated for the treatment of female stress urinary incontinence (SUI) with 2 different SIMS systems were retrospectively evaluated. Patient characteristics, physical examination results, and quality of life (QoL) questionnaires were used to evaluate the patients. Primary efficacy endpoints were the cure and failure rates. Secondary efficacy endpoints were complications and differences in QoL questionnaires. RESULTS: Eighty-three patients from group 1 (Ophira SIMS system) and 77 patients from group 2 (Gallini SIMS system) were evaluated. There was no significant difference between the 2 groups regarding patient characteristics. The objective cure rates were found to be 83.1 and 79.2% in group 1 and group 2, respectively (p = 0.09). Mesh-related complications, such as anchor displacement, bladder erosion, vaginal erosion, and groin pain, were more common in group 1. No severe complications were observed. For both groups, a significant improvement in all scores of QoL questionnaires was observed after surgery; however, the differences between 2 groups were not significant. CONCLUSIONS: The present study showed that the treatment of female SUI with 2 different SIMS systems had similar efficacy, complication rates, and scores in QoL questionnaires.

Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) is the involuntary loss of urine on effort and is a condition that negatively interferes with various aspects of a woman's life. This study aimed to demonstrate the non-inferiority of the less invasive single-incision mini-sling (SIMS) method in objective and subjective cures in relation to tension-free transobturator tape (TOT) in two analyses, per protocol and intention to treat, and secondarily to evaluate complications and quality of life. METHODS: This study was a randomized controlled trial (RCT). Participants in this study included 105 women with a clinical diagnosis of stress predominant urinary incontinence and urodynamic results demonstrating SUI and absence of detrusor overactivity. Patients were evaluated pre- and postoperatively through anamnesis, physical examination, urinalysis, urine culture and susceptibility testing, simplified pad test, the Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) and Urogenital Distress Inventory Short Form (UDI-6). RESULTS: Regarding the objective cure, SIMS was non-inferior to TOT (p < 0.05). However, the same was not found for the subjective cure (p > 0.05). There were no differences in the complication rates (p > 0.05). However, in the TOT group, bladder perforation (2.4%), tape exposure (2.4%) and urinary retention occurred, lasting > 7 days (2.4%). In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05). CONCLUSIONS: The non-inferiority of SIMS in relation to TOT was only demonstrated in the objective cure. There were no significant differences between groups regarding complications and quality of life.

Impact of per-operative antibiotics on the urinary tract infection rate following mid-urethral sling surgery for urinary incontinence: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The objective was to compare the effect of antibiotics versus no antibiotics prophylaxis per-operatively on the frequency of urinary tract infection (UTI) following mid-urethral sling application to treat stress or mixed urinary incontinence. METHODS: This study was designed as a multicenter prospective randomized trial. Women were included from eight centers in three countries. Women were aged under 60 years and had objectively verified stress urinary incontinence. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either antibiotics or no antibiotics. UTI was defined in accordance with the Centers for Disease Control (CDC) criteria for symptomatic UTI. Women were followed up at 3, 12, and 36 months. This was part of a trial comparing subjective cure rate in relation to application of Ajust® (single-incision mid-urethral slings) versus standard mid-urethral slings. RESULTS: The main outcome was to evaluate if per-operative antibiotics had any impact on UTI following sling surgery. In total, 305 women were randomized (158 [52%] to antibiotics and 147 [48%] to no antibiotics). Demographic data disclosed no differences between the two groups. The trial did not show any difference between the two groups regarding the frequency of postoperative UTI. Logistic regression analysis disclosed only residual urine volume at 3 months' follow-up as a significant risk factor for UTIs. Per-operative antibiotics had no influence on the frequency of mesh erosions or any other complication. CONCLUSIONS: Our trial does not suggest any beneficial effect of per-operative antibiotics on the risk of post-operative UTIs.

TVT-O vs. TVT-Abbrevo for stress urinary incontinence treatment in women: a randomized trial.

INTRODUCTION: To compare the efficacy, safety and complications of the trans-obturator midurethral sling from inside to outside (TVT-O) and of the shorter trans-obturator midurethral sling (TVT-Abbrevo) for treatment of female SUI. MATERIALS AND METHODS: One hundred fifty-eight recruited patients were randomized into either the TVT-O or TVT-Abbrevo group. Preoperative assessment included history and general assessment, urinalysis and urine culture, urogynaecological clinical examination, urodynamic evaluation and urogynaecologic interview by ICIQ-SF-UI, PGI-I and PISQ12. Operative time, perioperative complications, spontaneous voiding, postoperative complications and hospital stay were prospectively recorded in all patients. At 3, 6, 12, 24 and 36 months after surgery, patients were asked to answer urogynaecological interviews by ICIQ-SF-UI, PGI-I and PISQ12. The urodynamic assessment was performed at 12, 24 and 36 months. Success rate was assessed at 12, 24 and 36 months postoperatively. RESULTS: Overall, 138 of 158 patients (87%) were cured of SUI 36 months after the operation with no significant differences between groups [69 (87%) and 69 (87%) patients in the TVT-O and TVT Abbrevo groups, respectively]. The two groups did not significantly differ in operative time, intraoperative blood loss and length of hospital stay. Nine patients (11%) had postoperative groin pain in the TVT-O group and one patient in the TVT Abbrevo group (p = 0.02). Three-year control demonstrated an equal objective cure rate in both groups. There was a significant improvement in total PISQ-12 and ICIQ-SF-UI scores in both groups at 36 months FU. CONCLUSION: TVT-Abbrevo has similar efficacy and safety compared with TVT-O in women with SUI; the use of a shorter sling reduces postoperative pain.

[Short-term evaluation of Altis® single-incision sling in women stress urinary incontinence]. / Évaluation à court terme de la mini-bandelette Altis® dans l'incontinence urinaire d'effort chez la femme.

INTRODUCTION: Midurethral slings are the main surgical treatment of stress urinary incontinence. Altis is a minimally invasive single-incision sling system. The aim of this study is to report the safety and efficacity results during a year of follow up. MATERIALS AND METHODS: This single-centre and retrospective study has been performed in a university hospital, between February 2015 and May 2018. We included women aged more than 18, complaining a stress urinary incontinence with a urethral hypermobility and positive support maneuvers, who had failed from non surgical treatment. A prospective data collection has been done at the moment of inclusion, peroperative time, at 6 weeks, 6 months and a year after the procedure. The main evaluation criteria was the cure rate at twelve months. RESULTS: Thirty patients were included in our study. The mean age was 45,4±12,9 years old, the mean ICIQ-UI score was 13,5±4,06 and the median pad test was at 12g. Ninety three percent of the procedures were done as ambulatory surgery. The average operating time was at 22,2minutes. Overall, 75% of our patients were objectively cured and 14,2% were in fail of this treatment. CONCLUSION: The short term results show a good efficacity and safety of this procedure. But its place remains to be defined in relation to other techniques, TVT, TOT and non-prosthetic techniques. LEVEL OF EVIDENCE: 3.

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. METHODS: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. RESULTS: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. CONCLUSIONS: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.

Mini-Sling Ophira at 8 Years Follow-Up: Does It Sustain Results?

PURPOSE: To evaluate mini-sling long-term results and correlate them to failure predictors. Many studies show comparable results among different single-incision slings developed as an attempt to reduce complications while keeping good results, but there is a lack of evidence about mini-slings outcomes in the long term. METHODS: This prospective, single-center study evaluated 40 patients for long-term outcomes after mini-sling placement. Objective cure was defined as leakage of less than 1 g in 1-hour pad-test and no leakage at Valsalva maneuver. An objective improvement was defined as leakage of a maximum 50% of the preoperative test. Subjective continence was considered as a zero score at International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). Patients were also evaluated for comorbidities and previous surgeries. RESULTS: The mean age was 56 (±9.3) years, the mean ICIQ-SF score was 16 (±2.98) before surgery and 3.5 (± 5) at last follow-up, showing sustained improvement in the long term, mean 100 (84-109) months follow-up. The objective results show 67.5% of success, 17.5% of improvement, and 15% of failure. Age and parity were not related to outcomes (p = 0.33), but previous surgeries increase failure rate with 5.66 OR (p = 0.04). Success, improvement, and failure rates were 85, 10, and 5% for treatment-naive patients versus 50, 25, and 25% for patients with previous surgeries, respectively. CONCLUSION: Mini-sling Ophira shows good long-term results with low complications rates in patients without previous anti-incontinence surgery. Randomized trials are necessary to compare mini-slings results to other mid-urethral slings in recurred stress urinary incontinence.

Randomized controlled trial comparing single-incision mini-sling and transobturator midurethral sling for the treatment of stress urinary incontinence: 3-year follow-up results.

BACKGROUND: The role of single-incision mini-slings (SIMS) in stress urinary incontinence (SUI) management is still not elucidated. OBJECTIVE: To compare efficacy and safety of SIMS and transobturator sling (TOT) for SUI after 36-month follow-up. METHODS: A randomized controlled clinical trial involving 130 women with SUI that had either SIMS or TOT. Primary outcomes: objective cure defined as negative cough stress and pad tests, and subjective cure reported as satisfaction and no desire for additional treatment. SECONDARY OUTCOMES: quality-of-life by IQOL and UDI-6 questionnaires, complications and reoperation rates. Student's t, χ2 , Fisher's exact, and Mann-Whitney tests, ANOVA and P < 0.05 as cut-off point were used for statistics. RESULTS: A total of 82 patients (n:41 each arm) completed 36-month follow-up. Objective cure was lower in the SIMS compared to TOT groups by both per protocol (68.3% and 90.2%, respectively, P = 0.027) and intention-to-treat analysis considering missing data as failures (40.6% and 60.7%, respectively, P = 0.035), while similar in both groups (81.2% and 93.4%, respectively) considering missing data as successes. Subjective cure rates were similar for both groups. TOT group presented better outcome regarding the avoidance and limiting behavior domain of IQOL (P = 0.021), and UDI-6 scores (P = 0.026). Seven out of 69 (10.1%) women in the SIMS group compared with two out of 61 (3.3%) in the TOT group (P = 0.172) had repeat surgery due to recurrent SUI at year follow up. CONCLUSION: TOT was associated to higher objective cure rate than SIMS for SUI treatment although satisfaction rate was similar for both groups 3 years postoperative.

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial.

INTRODUCTION: The primary aim of this study was to compare the objective and subjective outcomes and short-term complication rates of an adjustable single-incision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS). The secondary aim was to report pain perception and complications at the one-year follow up. MATERIAL AND METHODS: The study was designed as a multicenter prospective randomized trial where women were included from eight centers in Denmark, Norway and Sweden. The trial was registered at ClinicalTrials.gov: NCT01754558. A total of 305 women less than 60 years old with verified stress urinary incontinence were included. All women were randomized to SIMS (Ajust® ; n = 155) or SMUS (TVT, TVT-O or TOT; n = 150) and were evaluated by stress test and bladder diary before and after surgery and symptoms related to incontinence using ICIQ-SF, PISQ-12 and PGI-S and PGI-I. Objective cure was defined as no leakage during a stress test and subjective cure defined as no leakage stated in the bladder diary or no indication of urinary leakage in the ICIQ-SF. Furthermore, mesh exposure and dyspareunia were recorded. RESULTS: In total, 280 women [141 (91%) in the SIMS and 139 (94%) in the SMUS groups] participated in the one-year follow up. No difference between the groups was observed regarding objective and subjective outcomes. VAS score disclosed a lower postoperative pain perception in the SIMS group than in the SMUS group. CONCLUSIONS: Ajust® appears to be as efficient as SMUS regarding objective and subjective outcomes and was associated with less pain perception during the postoperative period.

Retropubic tissue fixation system tensioned mini-sling carried out under local anesthesia cures stress urinary incontinence and intrinsic sphincter deficiency: 1-year data.

OBJECTIVES: To assess the outcomes of the tissue fixation system midurethral sling for the treatment of intrinsic sphincter deficiency. METHODS: We retrospectively studied a total of 96 intrinsic sphincter deficiency patients treated with the tissue fixation system midurethral sling at Yokohama Motomachi Women's Clinic from 2006 to 2015. We evaluated intraoperative and 1-year postoperative results. Regarding the cure rate, we divided patients into three groups: (i) patients with maximum urethral closure pressure <20 and Valsalva leak point pressure <65 combined (n = 17); (ii) patients with maximum urethral closure pressure <20 (n = 55); and (iii) patients with Valsalva leak point pressure <65 (n = 47). RESULTS: The median age was 63 years (range 38-89 years). The median operating time including local anesthesia was 24 min (range 12-55 min) and median blood loss was 5.0 mL (range 3-69 mL). All operations were day surgery under local anesthesia. Postoperative pain was minimal. All patients were discharged the same day. There were no intraoperative complications except one bladder perforation. There were no tape rejections. The 1-year postoperative cure rates were: 88.2% among patients with maximum urethral closure pressure <20 and Valsalva leak point pressure <65, 90.9% for patients with maximum urethral closure pressure <20, and 85.1% among patients with Valsalva leak point pressure <65. CONCLUSIONS: The tissue fixation system midurethral sling operation is a simple, safe and effective operation for older women with intrinsic sphincter deficiency, and it can be carried out under local anesthesia.

Adjustable single incision sling Ajust - the effects of first operations controlled by pelvic floor sonography.

OBJECTIVE: The aim of this study is to evaluate using PFS-TV the mid-term results of our first operative experience with implanting a single incision sling - Ajust™. MATERIAL AND METHODS: One and the same surgeon has operated all the patients with symptoms of stress urinary incontinence. Ajust was the only performed procedure. Postoperative evaluation consisted of: a standardized interview and examination, a cough test and a PFS-TV for evaluation of urinary continence and tape location. PFS-TV was performed under standardized conditions at rest and during maximum Valsalva maneuver. RESULTS: This is a retrospective analysis of data from a total of 31 patients who attended a control visit between the 36th and the 50th month following the operation. Sixteen patients (51.6%) were cured. There were statistically significant differences in urethral mobility (p < 0.0007) and tape-urethra distance (p < 0.002) between cured and not-cured group. The difference in urethral length was not statistically significant. 77.8% of women with a hypermobile urethra was cured in contrast to 15.4% with a normobile urethra. Neither of the groups had a hypomobile urethra patient. There were no significant complications intra- or post-operatively. De novo urgency was observed in 1 patient only. CONCLUSIONS: Implantation of Ajust tape seems to be a safe mode of operative treatment for SUI in women. Our mid-term results suggest that long term effects might be worse compared to retropubic or transobturator tapes, especially at first operative experience with Ajust. Urethral mobility seems to be an important risk factor for treatment failure after Ajust implantation. It seems that patients that may benefit from Ajust most are women with urethral hypomobility but this needs to be verified with a prospective study.

[Surgical treatment of stress urinary incontinence].

OBJECTIVE: Urinary stress incontinence considerably decreases the life quality of women, which makes search for effective methods of treatment essential. The research presents results of surgical treatment of 230 patients with stress urinary incontinence between 2011 and 2014. MATERIALS AND METHODS: Efficiency of treatment of urinary incontinence in women, using Tension-free Vaginal Tape (TVT-O) and mini-sling Ophira was presented. The evaluation was made out of complaints and physical examination in target groups, including patients with concurrent genital prolapse and mixed urinary incontinence. For correct diagnosis all patients were submitted to urodynamic and ultrasound tests. In case of need M-cholinomimetic drugs were applied. To evaluate different complaints 5-graded visual analogue scale was worked out. Results of cough stress test were taken as main objective way to estimate effectiveness of the treatment. RESULTS: The research showed that application of TVT-O mesh and mini-sling Ophira turned out to be highly effective in treatment of urine stress incontinence in women. Among short-term complications urinary retention was most common (3,5 percent). To correct those complications alfa-adrenergic agonists, physiotherapy, and acupuncture were applied. Erosions of vaginal mucous had developed at the place where meshes were planted in 1,3 percent of cases. Only once it required mesh excision.

Mini Sling (Ophira) versus Pubovaginal Sling for Treatment of Stress Urinary Incontinence: A Medium-term Follow-up.

To compare two different procedures, mid-urethral mini sling (Ophira) and autologous rectus fascia sling, according to their medium-term subjective and objective outcome and satisfaction rates in the treatment of stress urinary incontinence in women. One hundred women with the main complaint of stress urinary incontinence were randomized to be treated with either mini sling (Ophira) or autologous rectus facia pubovaginal sling. Preoperative evaluation consisted of: physical examination, blood biochemistry urine analysis and culture, urinary tract ultrasound scan, conventional multi-channel urodynamic study, cystourethroscopy, cough induced stress test and Incontinence Impact Questionnaire (IIQ). The patients were objectively and subjectively re-evaluated at 1, 3, 6 and 12 postoperative months and the last visit and the collected data of more than one year follow-up were compared with preoperative assessments. Seventy two out of one hundred patients were followed for a mean time of 13.8±4.4 months (12-20 months range). Objective cure rate, according to cough-induced stress test was recorded in 88.6% and 89.2% of the mini sling (Ophira) and the rectus facia sling group respectively (P=1.0). Postoperative mean IIQ score decreased to 42.7±11.4 and 50.2±11.1 in the mini sling (Ophira) group versus rectus facia pubovaginal sling (P=0.007). Twenty eight (80%) and 23 (67%) patients in the mini sling (Ophira) and rectus facia pubovaginal sling were satisfied with the operation (P=0.23). There is no significant difference between the mini sling (Ophira) and autologous rectus fascia sling procedure in the treatment of stress urinary incontinence at medium-term follow-up.

[Ajust(®): prospective study and 1-year follow-up - a series of 60 female patients]. / Ajust(®) : étude prospective et suivi à un an d'une série de 60 patientes.

OBJECTIVES: Evaluate functional and anatomical outcomes as well as complications, 1year after the implantation of the Ajust(®) sub-urethral adjustable single-incision sling. STUDY DESIGN: Prospective study on 60 female patients suffering from stress urinary or mixed urinary incontinence with quality of life assessment. Ambulatory surgeries were performed under local anesthesia with or without sedation. Pain was evaluated using the VAS scale. Postoperative follow-up was performed at 2 and 12months. RESULTS: Forty-eight patients suffered from stress incontinence only, with one of them suffering from sphincter deficiency, and the remaining 12 suffered from mixed urinary incontinence. Mean surgery time was 7.15minutes. All patients received a local anesthesia, and 33 were sedated. Per-operative pain level was equal to 31.8/100, and 17/100 upon discharge. A 100mL per-operative hemorrhage was described. At 2-month follow-up, four de novo urgency, four de novo dysuria, one urinary infection, 11 palpable lateral cords, 12 moderate postoperative pain were described. At 1-year follow-up, two mesh exposures formed, including one expelled anchor for one of them. At 1year, cure rate, improvement and failure rate were respectively 89.6%, 6.9% and 3.4%. Quality of life indexes were significantly improved. One patient required a new surgery at 2months, due to initial failure. CONCLUSIONS: The efficacy of this mini-invasive sling, without specific complication, must be compared with the other classic sub-uretral slings.

Long-term efficacy of the single-incision mini-sling procedure using surgeon-tailored mesh.

OBJECTIVES: To evaluate the long-term efficacy of a surgeon-tailored single-incision mini-sling procedure (SIMS) for the surgical treatment of stress urinary incontinence (SUI) in terms of objective cure rates, quality of life, and cost-effectiveness. STUDY DESIGN: This retrospective study included 93 women with pure SUI who underwent surgeon-tailored SIMS. All patients were evaluated with a stress cough test and quality of life questionnaire (Incontinence Impact Questionnaire [IIQ-7]) at 1 month, 6 months, 1 year, and last follow-up visit (4-7 years). Early and late (after 1 month) complication rates and the reoperation rate were also evaluated. RESULTS: Mean operative time and follow-up duration were 12 ± 2.5 min and 5.7 years (4-7 years), respectively. Objective cure rates determined by the stress cough test were 83.8%, 94.6%, 93.5%, and 91.3% at 1 month, 6 months, 1 year, and last follow-up, respectively. IIQ-7 scores improved at every visit compared to the preoperative value. There were no cases of hematuria, bladder perforation, or major bleeding requires a blood transfusion. CONCLUSION: Our results suggest that the surgeon-tailored SIMS procedure has high efficacy and low complication rates and offers a practical and inexpensive alternative to commercial high-cost SIMS systems.