Safety and Efficacy Report for the Use of Poly-4-Hydroxybutyrate as a Retropubic Mid-Urethral Sling (MUS) for Stress Urinary Incontinence: A Prospective 24 Months Follow-Up of New Poly-4-Hydroxybutyrate TephaFlex SUI Bioresorbable MUS.

STUDY OBJECTIVE: To investigate the feasibility and safety of the retropubic mid-urethral sling (MUS) procedure with a resorbable mesh implant made of poly-4-hydroxybutyrate (P4HB). DESIGN: A prospective clinical cohort study with 24 months follow-up. SETTING: A tertiary academic hospital. PATIENTS: Seventeen women with moderate to severe stress urinary incontinence (SUI). INTERVENTIONS: A retropubic MUS procedure with P4HB sling. MEASUREMENTS AND MAIN RESULTS: Seventeen women underwent an uncomplicated MUS procedure with a new sling made of resorbable P4HB. Following safety criteria, there has been no need to stop the study before 24 months' end point. Three serious adverse events were reported during follow-up: (1) inability to void urine after 1 week postsurgery, (2) a hysterectomy and bilateral oophorectomy performed due to a precancerous endometrial lesion at 16 months after initial MUS procedure and (3) exposed mesh with a part of device sheath left behind. These participants underwent an uncomplicated reintervention with no additional and/or permanent harm. Reinterventions because of failure of cure contained 3 second MUS procedures and one admission of urethral bulking agent. Seventy-six percent and 47 percent of patients were objectively cured of SUI at 12 and 24 months, respectively. CONCLUSIONS: Preliminary evidence suggests that a sling made of P4HB can be safely used for MUS procedures and could be an alternative for permanent polypropylene slings in patients that prefer the use of nonpermanent material.

Single-incision sling operations for urinary incontinence in women.

BACKGROUND: Stress urinary incontinence imposes a significant health and economic burden on individuals and society. Single-incision slings are a minimally-invasive treatment option for stress urinary incontinence. They involve passing a short synthetic device through the anterior vaginal wall to support the mid-urethra. The use of polypropylene mesh in urogynaecology, including mid-urethral slings, is restricted in many countries. This is a review update (previous search date 2012). OBJECTIVES: To assess the effects of single-incision sling operations for treating urinary incontinence in women, and to summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from: CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, and two trials registers. We handsearched journals, conference proceedings, and reference lists of relevant articles to 20 September 2022. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials in women with stress (or stress-predominant mixed) urinary incontinence in which at least one, but not all, trial arms included a single-incision sling. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. The primary outcome was subjective cure or improvement of urinary incontinence. MAIN RESULTS: We included 62 studies with a total of 8051 women in this review. We did not identify any studies comparing single-incision slings to no treatment, conservative treatment, colposuspension, or laparoscopic procedures. We assessed most studies as being at low or unclear risk of bias, with five studies at high risk of bias for outcome assessment. Sixteen trials used TVT-Secur, a single-incision sling withdrawn from the market in 2013. The primary analysis in this review excludes trials using TVT-Secur. We report separate analyses for these trials, which did not substantially alter the effect estimates. We identified two cost-effectiveness analyses and one cost-minimisation analysis. Single-incision sling versus autologous fascial sling One study (70 women) compared single-incision slings to autologous fascial slings. It is uncertain if single-incision slings have any effect on risk of dyspareunia (painful sex) or mesh exposure, extrusion or erosion compared with autologous fascial slings. Subjective cure or improvement of urinary incontinence at 12 months, patient-reported pain at 24 months or longer, number of women with urinary retention, quality of life at 12 months and the number of women requiring repeat continence surgery or sling revision were not reported for this comparison. Single-incision sling versus retropubic sling Ten studies compared single-incision slings to retropubic slings. There may be little to no difference between single-incision slings and retropubic slings in subjective cure or improvement of incontinence at 12 months (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.91 to 1.07; 2 trials, 297 women; low-certainty evidence). It is uncertain whether single-incision slings increase the risk of mesh exposure, extrusion or erosion compared with retropubic minimally-invasive slings; the wide confidence interval is consistent with both benefit and harm (RR 1.55, 95% CI 0.24 to 9.82; 3 trials, 267 women; low-certainty evidence). It is uncertain whether single-incision slings lead to fewer women having postoperative urinary retention compared with retropubic slings; the wide confidence interval is consistent with possible benefit and harm (RR 0.47, 95% CI 0.12 to 1.84; 2 trials, 209 women; low-certainty evidence). The effect of single-incision slings on the risk of repeat continence surgery or mesh revision compared with retropubic slings is uncertain (RR 4.19, 95% CI 0.31 to 57.28; 2 trials, 182 women; very low-certainty evidence). One study reported quality of life, but not in a suitable format for analysis. Patient-reported pain at more than 24 months and the number of women with dyspareunia were not reported for this comparison. We downgraded the evidence due to concerns about risks of bias, imprecision and inconsistency. Single-incision sling versus transobturator sling Fifty-one studies compared single-incision slings to transobturator slings. The evidence ranged from high to low certainty. There is no evidence of a difference in subjective cure or improvement of incontinence at 12 months when comparing single-incision slings with transobturator slings (RR 1.00, 95% CI 0.97 to 1.03; 17 trials, 2359 women; high-certainty evidence). Single-incision slings probably have a reduced risk of patient-reported pain at 24 months post-surgery compared with transobturator slings (RR 0.12, 95% CI 0.02 to 0.68; 2 trials, 250 women; moderate-certainty evidence). The effect of single-incision slings on the risk of dyspareunia is uncertain compared with transobturator slings, as the wide confidence interval is consistent with possible benefit and possible harm (RR 0.78, 95% CI 0.41 to 1.48; 8 trials, 810 women; moderate-certainty evidence). There are a similar number of mesh exposures, extrusions or erosions with single-incision slings compared with transobturator slings (RR 0.61, 95% CI 0.39 to 0.96; 16 trials, 2378 women; high-certainty evidence). Single-incision slings probably result in similar or reduced cases of postoperative urinary retention compared with transobturator slings (RR 0.68, 95% CI 0.47 to 0.97; 23 trials, 2891 women; moderate-certainty evidence). Women with single-incision slings may have lower quality of life at 12 months compared to transobturator slings (standardised mean difference (SMD) 0.24, 95% CI 0.09 to 0.39; 8 trials, 698 women; low-certainty evidence). It is unclear whether single-incision slings lead to slightly more women requiring repeat continence surgery or mesh revision compared with transobturator slings (95% CI consistent with possible benefit and harm; RR 1.42, 95% CI 0.94 to 2.16; 13 trials, 1460 women; low-certainty evidence). We downgraded the evidence due to indirectness, imprecision and risks of bias. AUTHORS' CONCLUSIONS: Single-incision sling operations have been extensively researched in randomised controlled trials. They may be as effective as retropubic slings and are as effective as transobturator slings for subjective cure or improvement of stress urinary incontinence at 12 months. It is uncertain if single-incision slings lead to better or worse rates of subjective cure or improvement compared with autologous fascial slings. There are still uncertainties regarding adverse events and longer-term outcomes. Therefore, longer-term data are needed to clarify the safety and long-term effectiveness of single-incision slings compared to other mid-urethral slings.

The effect of CO2 laser therapy on vaginal microcirculatory parameters in an animal model for genitourinary syndrome of menopause.

BACKGROUND: Vaginal laser therapy for the treatment of genitourinary syndrome of menopause (GSM) has been introduced to the market with limited (pre)clinical and experimental evidence supporting its efficacy. It is suggested that vaginal laser therapy increases epithelial thickness and improves vascularization, but the underlying biological working mechanism has not been substantiated yet. OBJECTIVE: To evaluate the effects of CO2 laser therapy on vaginal atrophy using noninvasive incident dark field (IDF) imaging in a large animal model for GSM. DESIGN, SETTING, AND PARTICIPANTS: An animal study was conducted between 2018 and 2019 and included 25 Dohne Merino ewes, of which 20 underwent bilateral ovariectomy (OVX) to induce iatrogenic menopause, and 5 did not. The total study duration was 10 months. INTERVENTIONS: Five months after OVX, ovariectomized ewes received monthly applications of CO2 laser (n = 7), vaginal estrogen (n = 7), or no treatment (n = 6) for 3 months. IDF imaging was performed monthly in all animals. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the proportion of image sequences containing capillary loops (angioarchitecture). Secondary outcomes included focal depth (epithelial thickness), and quantitative measures of vessel density and perfusion. Treatment effects were evaluated using ANCOVA and binary logistic regression. RESULTS AND LIMITATIONS: Compared to OVX-only, ewes treated with estrogen demonstrated a higher capillary loops proportion (4% vs. 75%, p < 0.01), and higher focal depth (60 (IQR 60-80) vs. 80 (IQR 80-80) p < 0.05). CO2 laser therapy did not change microcirculatory parameters. As the ewes' vaginal epithelium is thinner than that of humans, it may demand different laser settings. CONCLUSIONS: In a large animal model for GSM, CO2 laser therapy does not affect microcirculatory outcomes related to GSM, whereas vaginal estrogen treatment does. Until more homogeneous and objective evidence about its efficacy is available, CO2 laser therapy should not be adopted into widespread practice for treating GSM.

Vaginal changes after ovariectomy in ewes: A large animal model for genitourinary syndrome of menopause.

OBJECTIVE: To evaluate the effect of iatrogenic menopause on the physiology of the vagina of the ewe and to evaluate if vaginal changes in ewes can be translated to women with genitourinary syndrome of menopause (GSM). METHODS: Preclinical research with Dohne Merino ewes. Iatrogenic menopause was induced by bilateral ovariectomy (OVX). Animals were randomized for surgery, blinded for allocation and outcome assessment. Differences between groups were determined by linear regression analyses at 5 months after OVX. Outcome measures were vaginal epithelial thickness, pH, vaginal maturation value, vaginal maturation index, epithelial glycogen accumulation, content of elastin fibers, collagen, and vascularity. RESULTS: OVX ewes (n = 20) showed epithelial thinning of the vaginal wall from 146 µm to 47 µm (mean, P < 0.001). Furthermore, epithelial glycogen accumulation and vascularity of the vaginal wall significantly decreased (43% and 23%, respectively) as compared with the control group (no intervention; n = 5). No significant differences were found for other outcome measures. CONCLUSION: This study established the ewe as a suitable large animal model for GSM. Furthermore, the similar relevant outcomes in humans and ewes hold great value for future translational research for the evaluation and optimization of different treatment modalities for GSM.

Validation of an ovine vesicovaginal fistula model.

INTRODUCTION AND HYPOTHESIS: A representative, large animal model of vesicovaginal fistulas is needed for the training of surgeons and for the development of new surgical techniques and materials for obstetric fistula repair. METHODS: The safety, feasibility, and reproducibility of vesicovaginal fistula creation were studied in 4 adult female sheep. A 1-cm fistula was created between the vagina and the bladder through a transvaginal approach. The defect was allowed to heal for 8 weeks and the animals were then euthanized. The primary outcome was the fistula patency. Secondary outcomes were fistula size, urogenital dimensions, urodynamic evaluation, histology (inflammation, vascularization, collagen deposition) and biomechanical characteristics of the fistula edge (stress at break, maximum elongation, and stiffness). RESULTS: The transvaginal creation of a vesicovaginal fistula was safe. All animals survived the surgical procedure and follow-up period, without complications. Three of the four animals demonstrated a patent vesicovaginal fistula after 8 weeks. Baseline data are provided of the urogenital dimensions and the urodynamic, histological, and biomechanical characteristics of the model. CONCLUSIONS: The ewe is a safe, feasible, and reproducible model for vesicovaginal fistulas. The model can help to study new techniques and materials to boost surgical innovation for vesicovaginal fistula repair.

Risk Perceptions and Acceptance Towards the Uptake of Pertussis Vaccine Amongst the Healthcare Workers in Sabah and Sarawak

@#Introduction: The incidence of pertussis is increasing amongst adolescents and adults. Therefore, adults require booster vaccination for protection against pertussis infection. Vaccination among healthcare workers (HCW) should be prioritized when a country implements an adult vaccine. However, the coverage of pertussis vaccination is still deficient among HCW due to low-risk perception. Method: This was a cross-sectional study using Survey Monkey (online). A total of 920 HCWs comprising of doctors, assistant medical officers (AMO), nurses, and environmental health officers (EHO) working at the hospitals and district health offices in Sabah and Sarawak were selected to partake in the study using a multistage sampling method. The website containing the questionnaire was given to the participants using either email or WhatsApp. Results: A total of 853 responders of whom 22.2% were doctors, 58.1% were nurses, 10.1% were medical assistants, and 9.6% were environmental health officers responded to the questionnaire. Most of the respondents (81.5%) are willing to receive the pertussis vaccine. The Protection Motivation score was significantly different between those willing and those not willing to take the vaccine (p-value<0.001). Robust path analysis showed that sociodemographic factors (age, the institution of working and prior pertussis vaccination) (p=0.004), threat (p<0.001) and coping pathway (p<0.001) were linked with the willingness to uptake vaccine. Conclusion: The sociodemographic factors of the HCW can affect the willingness of the HCW to uptake the pertussis vaccine directly and indirectly through their risk perception towards pertussis.

Female Pelvic Medicine and Reconstructive Surgery challenges on behalf of the Collaborative Research in Pelvic Surgery Consortium: managing complicated cases : Series 5: management of recurrent stress urinary incontinence after midurethral sling exposure.

This case presents the work-up and management of a patient requesting surgical intervention for recurrent stress urinary incontinence after previous excision of a portion of her midurethral sling because of mesh exposure. Four international experts provide their approach to this complex case. There is little consensus regarding further surgery in a patient who has required mesh excision. Treatment by fascial sling was commonly considered and the literature review outlines the pros and cons of autologous fascia versus donor fascia for this specific case.

Management of recurrent pelvic organ prolapse after sacrocolpopexy. A video case series.

INTRODUCTION: The aim of this video case series is to demonstrate our experience with the surgical management of recurrent pelvic organ prolapse after sacrocolpopexy. METHODS: This is a series of seven patients who developed recurrent pelvic organ prolapse stage 2 or greater after sacrocolpopexy. The video shows short clips on the individualized surgical management using a laparoscopic approach. CONCLUSION: The surgical management of patients with recurrent pelvic organ prolapse poses a great challenge. In our cases the laparoscopic approach gave us the opportunity to diagnose the reason for surgical failure, to optimally restore the anatomy and function of the pelvic floor, and to limit the morbidity that is often seen in repeat surgery. Laparoscopic revision of sacrocolpopexy for recurrent pelvic organ prolapse is feasible but needs to be individualized. As the number of cases is limited, and available evidence is scarce, we recommend the use of a registry to prospectively follow up these patients and identify best practices.

Laparoscopic sacrocolpopexy: A comprehensive literature review on current practice.

Sacrocolpopexy is considered the preferred treatment for vaginal vault. However, numerous technical variants are being practiced. We aimed to summarize the recent literature in relation to technical aspects of laparoscopic sacrocolpopexy (LSC). We focused on surgical technique, mesh type, concomitant surgeries, and training aspects. We performed 2 independent literature searches in Medline, Scopus, the Cochrane library, and Embase electronic databases including the keywords: 'sacrocolpopexy', 'sacral colpopexy' and 'promontofixation'. Full text English-language studies of human patients, who underwent LSC, published from January 1, 2008 to February 26, 2019, were included. Levels of evidence using the modified Oxford grading system were assessed in order to establish a report of the available literature of highest level of evidence. Initially, 953 articles were identified. After excluding duplicates and abstracts screening, 35 articles were included. Vaginal fixation of the mesh can be performed with barbed or non-barbed (level 1), absorbable or non-absorbable sutures (level 2). Fixation of the mesh to the promontory can be performed with non-absorbable sutures or non-absorbable tackers (level 2). The current literature supports using type 1 mesh (level 2). Ventral mesh rectopexy can safely be performed with LSC while concurrent posterior repair has no additional benefit (level 2). There is no consensus regarding the preferred type of hysterectomy or the benefit of an additional anti urinary incontinence procedure. A structured learning program, as well as the number of procedures needed in order to be qualified for performing LSC is yet to be established. There are numerous variants for performing LSC. For many of its technical aspects there is little consensus.

Protection Motivation Theory-Based Questionnaire Validation to Predict Acceptance of Healthcare Workers towards Uptake of Pertussis Vaccine

@#Introduction: Pertussis is known to cause infection and reinfection to everyone irrespective of ages and countries. Therefore, adults do require vaccination for protection against pertussis infection especially the HCW. However, the pertussis vaccine coverage is low among HCW due to low-risk perception. Protection Motivation Theory (PMT) is one of the most cited theories to explain risk perception and intention to change. Therefore, we developed a questionnaire based on the subconstructs of the PMT to assess the acceptance of the pertussis vaccine amongst the HCWs in Sabah and Sarawak. The motive of this study is to validate this questionnaire to see its validity and reliability. Method: Data was collected using a self-administered questionnaire via an online survey (Monkey Survey). The questionnaire was given to 250 HCW. Items that were identified as a problem were modified to increase reliability. Further validation was done among 853 HCWs working in various parts of Sabah and Sarawak. Results: The Cronbach alpha of the overall construct of PMT during the first pilot study was 0.66 and improved to 0.82. Principal components factor analysis using varimax rotations showed that the first four factors explained 28%, 2%, 9% and 5% of the variance respectively. Both the one level and two-level modelling indicated that it’s a good fit model. Conclusion: The study instrument that was developed for the study has been tested and proven to be relevant to assess the risk perception of an HCW towards pertussis.

How cure rates drive patients' preference for urethral bulking agent or mid-urethral sling surgery as therapy for stress urinary incontinence.

AIMS: To assess the patients' median-accepted threshold of cure rate for urethral bulking agent (UBA) treatment compared to mid-urethral sling (MUS) surgery for treatment of female stress urinary incontinence (SUI). Secondly, to determine the correlation between treatment trade-off point and patient characteristics. METHODS: Women older than 18 years, with predominant SUI, seeking treatment, underwent a structured interview. The treatment trade-off point was determined in scenario one: UBA vs transobturator standard MUS surgery (SMUS) performed under general/spinal anesthesia with one-night hospital stay, and scenario 2: UBA compared to single-incision MUS surgery (SIMS) performed under local analgesia (with sedation) in a daycare setting. The treatment trade-off point was assessed by decreasing the cure rate of UBA from 85% to 10% with steps of 2% until the patient's treatment preference switched to SMUS/SIMS. RESULTS: One hundred and five patients were interviewed. Mean age was 52 years (SD, ±13.4). The median trade-off point for scenarios 1 and 2 was 79% (interquartile range [IQR]: 69, 85) and 85% (IQR: 71, 85), respectively. Patients with longer duration of SUI symptoms were willing to trade more efficacy to prefer UBA treatment. CONCLUSIONS: Patients with SUI are willing to trade a lower cure rate to prefer UBA over SMUS to avoid hospitalization and general anesthesia. When SIMS is performed in a daycare setting under local analgesia, the majority of patients with SUI are of the opinion that cure rates of UBA should be at least as high as SIMS to be worth considering. The treatment preference is not strongly correlated with the patients' characteristics.

Retrospective review of intra- and post-operative complications with minimal versus large space of Retzius infiltration at the time of retropubic TVT placement.

INTRODUCTION AND HYPOTHESIS: A concern when using the retropubic tension-free vaginal tape (TVT) for stress urinary incontinence (SUI) is bladder perforation. This article describes a technique hypothesised to reduce the risk of intra-operative bladder perforation, termed the large space of Retzius infiltration (LSORI) technique. A large volume of infiltration of 360 ml saline-vasoconstrictor solution (180 ml × 2) into the space of Retzius (LSORI) at the time of retropubic TVT insertion will reduce the incidence of intra-operative bladder perforations. METHODS: This was a retrospective study reviewing the medical records of 89 women who underwent the retropubic TVT procedure at two urogynaecology Units. The intra- and post-operative characteristics associated with minimal (MSORI) versus large retropubic space of Retzius infiltrations (LSORI) were examined. RESULTS: Eighty-nine patients undergoing SUI surgery met the inclusion criteria. Forty-one patients had MSORI (volume range 20-60 ml bilaterally) versus 48 who had the 180-ml bilateral LSORI. No bladder perforations (0%) occurred in the LSORI group versus four in the MSORI group (9.8%), found to be statistically significant (p = 0.013). All other outcomes examined had no statistical difference. The TVT-related pain incidence: 8.3% (LSORI) versus 9.8% (MSORI). Post-operative urinary retention incidence was 6.3% (LSORI) and 14.6% (MSORI). Retropubic haematoma incidence was 0% (LSORI) and 2.4% (MSORI). Post-operative UTI rate was 12.5% (LSORI) and 17.1% (MSORI). CONCLUSIONS: This retrospective review revealed the potentially beneficial effect of the large (180 ml × 2) bilateral SORI with retropubic TVT placement in terms of the reduction in risk of bladder perforation. It also showed no potential added risk of post-operative complications.

Morbidity of a Single Incision Transvaginal Mesh to Correct Apical Prolapse.

STUDY OBJECTIVE: To determine complications and related reintervention rates associated with use of the Uphold Vaginal Support System (Boston Scientific, Boston, MA) for symptomatic vaginal apical prolapse. DESIGN: A multicenter retrospective study. SETTING: Two teaching hospitals. PATIENTS: Fifty-nine women with symptomatic vaginal apical prolapse. INTERVENTION: Vaginal apical prolapse surgery using the Uphold Mesh Kit system with or without other concomitant procedures. MEASUREMENTS AND MAIN RESULTS: A chart review was performed, including the following parameters: perioperative and postoperative complications, repeat surgery, and recurrence rate. A total of 59 patients met the criteria for inclusion in the study. Bladder perforation occurred perioperatively in 1 patient. Postoperative voiding difficulties were observed in 16 patients (27.1%), including 9 women (15.2%) who left the hospital with an indwelling catheter in place. There were 5 cases (8.5%) of transient groin pain, all of which resolved spontaneously. One patient developed a vaginal hematoma. Nine women (15%) required reoperation, including 4 (6.7%) because of recurrent prolapse and 1 (2%) for pelvic pain considered related to the mesh. Three patients (5%) required release of a midurethral sling (MUS) that had been placed concomitantly with the Uphold system. Two patients (3%) required a MUS for de novo stress incontinence. CONCLUSION: Use of the Uphold Vaginal Support System for symptomatic vaginal apical prolapse was associated with a significant risk of obstructed micturition. In our study population, 15% required repeat surgery, mainly for recurrent pelvic organ prolapse and de novo stress urinary incontinence. No surgical-related complication resulted in long-term morbidity.

Laparoscopic surgical anatomy for pelvic floor surgery.

Understanding anatomy is one of the pillars for performing a safe, effective, and efficient surgery, but recently, it is reported that there has been a decline in teaching anatomy during the preclinical years of medical school. There is also evidence that by the time a medical student becomes a clinician, a considerable proportion of the basic anatomy knowledge is lost. Hence, it is crucial for surgeons performing or assisting in pelvic floor surgery to revisit this integral clinical aspect of pelvic anatomy for performing a safe surgery. Pelvic organ prolapse repair, especially abdominal laparoscopic sacrocolpopexy, which is the gold standard of pelvic organ prolapse repair, presents a significant challenge to surgeons because the technique requires thorough and meticulous negotiation through abdomino-pelvic vascular structures and nerves supplying the pelvis, rectum, and ureters. The abdominal laparoscopic sacrocolpopexy surgery requires surgeons to have a deep understanding of anatomy to prevent potential life-threatening complications, which is as critical as it is for a pilot to understand the navigation route for a safe landing. This review is an extensive look and a great reminder to laparoscopic surgeons working in the pelvic cavity, especially those performing a pelvic floor surgery, about the anatomical safe routes for performing laparoscopic pelvic floor repairs. For easy reading and clear understanding, we have described step by step the safe anatomical journey a surgeon needs to take during laparoscopic sacrocolpopexy. We divided the technique into five critical anatomic locations (landmarks), which serves as our "flight map" for performing safe and efficient laparoscopic sacrocolpopexy.

Single-incision sling operations for urinary incontinence in women.

BACKGROUND: Urinary incontinence has been shown to affect up to 50% of women. Studies in the USA have shown that up to 80% of these women have an element of stress urinary incontinence. This imposes significant health and economic burden on society and the women affected. Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formation. This has led to the development of third-generation single-incision slings, also referred to as mini-slings.It should be noted that TVT-Secur (Gynecare, Bridgewater, NJ, USA) is one type of single-incision sling; it has been withdrawn from the market because of poor results. However, it is one of the most widely studied single-incision slings and was used in several of the trials included in this review. Despite its withdrawal from clinical use, it was decided that data pertaining to this sling should be included in the first iteration of this review, so that level 1a data are available in the literature to confirm its lack of efficacy. OBJECTIVES: To assess the effectiveness of mini-sling procedures in women with urodynamic clinical stress or mixed urinary incontinence in terms of improved continence status, quality of life or adverse events. SEARCH METHODS: We searched: Cochrane Incontinence Specialised Register (includes: CENTRAL, MEDLINE, MEDLINE In-Process) (searched 6 February 2013); ClinicalTrials.gov, WHO ICTRP (searched 20 September 2012); reference lists. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in women with urodynamic stress incontinence, symptoms of stress incontinence or stress-predominant mixed urinary incontinence, in which at least one trial arm involves one of the new single-incision slings. The definition of a single-incision sling is "a sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only a single vaginal incision (i.e. no exit wounds in the groin or lower abdomen)." DATA COLLECTION AND ANALYSIS: Three review authors assessed the methodological quality of potentially eligible trials and independently extracted data from individual trials. MAIN RESULTS: We identified 31 trials involving 3290 women. Some methodological flaws were observed in some trials; a summary of these is given in the 'Risk of bias in included studies' section.No studies compared single-incision slings versus no treatment, conservative treatment, colposuspension, laparoscopic procedures or traditional sub-urethral slings. No data on the comparison of single-incision slings versus retropubic mid-urethral slings (top-down approach) were available, but the review authors believe this did not affect the overall comparison versus retropubic mid-urethral slings.Types of single-incision slings included in this review: TVT-Secur (Gynecare); MiniArc (American Medical Systems, Minnetonka, USA); Ajust (CR Bard Inc., Covington, USA); Needleless (Mayumana Healthcare, Lisse, The Netherlands); Ophira (Promedon, Cordoba, Argentina); Tissue Fixation System (TFS PTY Ltd, Sydney, Australia) and CureMesh (DMed Co. Inc., Seoul, Korea).Women were more likely to remain incontinent after surgery with single-incision slings than with retropubic slings such as tension-free vaginal tape (TVTTM) (121/292, 41% vs 72/281, 26%; risk ratio (RR) 2.08, 95% confidence interval (CI) 1.04 to 4.14). Duration of the operation was slightly shorter for single-incision slings but with higher risk of de novo urgency (RR 2.39, 95% CI 1.25 to 4.56). Four of five studies in the comparison included TVT-Secur as the single-incision sling.Single-incision slings resulted in higher incontinence rates compared with inside-out transobturator slings (30% vs 11%; RR 2.55, 95% CI 1.93 to 3.36). The adverse event profile was significantly worse, specifically consisting of higher risks of vaginal mesh exposure (RR 3.75, 95% CI 1.42 to 9.86), bladder/urethral erosion (RR 17.79, 95% CI 1.06 to 298.88) and operative blood loss (mean difference 18.79, 95% CI 3.70 to 33.88). Postoperative pain was less common with single-incision slings (RR 0.29, 95% CI 0.20 to 0.43), and rates of long-term pain or discomfort were marginally lower, but the clinical significance of these differences is questionable. Most of these findings were derived from the trials involving TVT-Secur: Excluding the other trials showed that high risk of incontinence was principally associated with use of this device (RR 2.65, 95% CI 1.98 to 3.54). It has been withdrawn from clinical use.Evidence was insufficient to reveal a difference in incontinence rates with other single-incision slings compared with inside-out or outside-in transobturator slings. Duration of the operation was marginally shorter for single-incision slings compared with transobturator slings, but only by approximately two minutes and with significant heterogeneity in the comparison. Risks of postoperative and long-term groin/thigh pain were slightly lower with single-incision slings, but overall evidence was insufficient to suggest a significant difference in the adverse event profile for single-incision slings compared with transobturator slings. Evidence was also insufficient to permit a meaningful sensitivity analysis of the other single-incision slings compared with transobturator slings, as all confidence intervals were wide. The only significant differences were observed in rates of postoperative and long-term pain, and in duration of the operation, which marginally favoured single-incision slings.Overall results show that TVT-Secur is considerably inferior to retropubic and inside-out transobturator slings, but additional evidence is required to allow any reasonable comparison of other single-incision slings versus transobturator slings.When one single-incision sling was compared with another, evidence was insufficient to suggest a significant difference between any of the slings in any of the comparisons made. AUTHORS' CONCLUSIONS: TVT-Secur is inferior to standard mid-urethral slings for the treatment of women with stress incontinence and has already been withdrawn from clinical use. Not enough evidence has been found on other single-incision slings compared with retropubic or transobturator slings to allow reliable comparisons. A brief economic commentary (BEC) identified two studies which reported no difference in clinical outcomes between single-incision slings and transobturator mid-urethral slings, but single-incision slings may be more cost-effective than transobturator mid-urethral slings based on one-year follow-up. Additional adequately powered and high-quality trials with longer-term follow-up are required. Trials should clearly describe the fixation mechanism of these single-incisions slings: It is apparent that, although clubbed together as a single group, a significant difference in fixation mechanisms may influence outcomes.

The Effect of Vaginal Oestriol Cream on Subjective and Objective Symptoms of Stress Urinary Incontinence and Vaginal Atrophy: An International Multi-Centre Pilot Study.

AIM: Subjectively and objectively assess stress urinary incontinence (SUI) symptoms before and after topical oestrogen therapy. METHODS: A prospective study was performed in 3 centres in South-Africa, Australia and the Netherlands. Postmenopausal women with SUI were treated with topical oestriol cream for 6 weeks. The primary subjective outcome was the Patient's Global Impression of Improvement (PGI-I) scale. The primary objective outcome was vaginal pH. Secondary subjective outcomes were: the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form, the Incontinence Impact Questionnaire, the Urogenital Distress Inventory (UDI-6) and the most bothersome symptom approach. Secondary objective outcome was the erect cough pad test. Compliance was scored. RESULTS: A total of 68 women were enrolled. Half of the participants reported improvement on the PGI-I scale after treatment. Vaginal pH was significantly lower after treatment (median 5.3 (interquartile range (IQR) 4.5-6.0) vs. 5.0 (4.4-5.4), p = 0.002). Improvement on the UDI stress domain was observed (p = 0.01). No statistically significant differences were found in the other subjective outcomes. Baseline and repeat cough pad tests demonstrated a wide variation with no significant difference. Compliance was high (median 100 (IQR 83-100%)). CONCLUSION: Topical oestriol cream during 6 weeks improved quality of life and vaginal pH but no other objective measures of incontinence.

Single-incision sling operations for urinary incontinence in women.

BACKGROUND: Urinary incontinence has been shown to affect up to 50% of women. Studies in the United States have shown that up to 80% of these women have an element of stress urinary incontinence. Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formation. This has led to the development of third-generation single-incision slings, also referred to as mini-slings.It should be noted that TVT-Secur (Gynecare, Bridgewater, NJ, USA) is one type of single-incision sling; it has been withdrawn from the market because of poor results. However, it is one of the most widely studied single-incision slings and was used in several of the trials included in this review. Despite its withdrawal from clinical use, it was decided that data pertaining to this sling should be included in the first iteration of this review, so that level 1a data are available in the literature to confirm its lack of efficacy. OBJECTIVES: To assess the effectiveness of mini-sling procedures in women with urodynamic clinical stress or mixed urinary incontinence in terms of improved continence status, quality of life or adverse events. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE in process; we handsearched journals and conference proceedings (searched 6 February 2013) and searched ClinicalTrials.gov (searched 20 September 2012), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (searched 20 September 2012) and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in women with urodynamic stress incontinence, symptoms of stress incontinence or stress-predominant mixed urinary incontinence, in which at least one trial arm involves one of the new single-incision slings. The definition of a single-incision sling is "a sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only a single vaginal incision (i.e. no exit wounds in the groin or lower abdomen)." DATA COLLECTION AND ANALYSIS: Three review authors assessed the methodological quality of potentially eligible trials and independently extracted data from the individual trials. MAIN RESULTS: We identified 31 trials involving 3290 women. Some methodological flaws were observed in some trials; a summary of these is given in the 'Risk of bias in included studies' section.No studies compared single-incision slings versus no treatment, conservative treatment, colposuspension, laparoscopic procedures or traditional sub-urethral slings. Also no data on the comparison of single-incision slings versus retropubic mid-urethral slings (top-down approach) were available, but the review authors believe this did not affect the overall comparison versus retropubic mid-urethral slings.The types of single-incision slings included in this review were TVT-Secur (Gynecare), MiniArc (American Medical Systems, Minnetonka, MN, USA), Ajust (C.R. Bard, Inc.,Covington, GA, USA), Needleless (Mayumana Healthcare, Lisse, The Netherlands), Ophira (Promedon, Cordoba, Argentina), Tissue Fixation System (TFS PTY Ltd, Sydney, Australia) and CureMesh (D.Med. Co., Inc., Seoul, Korea).Women were more likely to remain incontinent after surgery with single-incision slings than with retropubic slings such as tension-free vaginal tape (TVT(TM)) (121/292, 41% vs 72/281, 26%; risk ratio (RR) 2.08, 95% confidence interval (CI) 1.04 to 4.14). Duration of the operation was slightly shorter for single-incision slings but with higher risk of de novo urgency (RR 2.39, 95% CI 1.25 to 4.56). Four of five studies in the comparison included TVT-Secur as the single-incision sling.Single-incision slings resulted in higher incontinence rates compared with inside-out transobturator slings (30% vs 11%; RR 2.55, 95% CI 1.93 to 3.36). The adverse event profile was significantly worse, specifically consisting of higher risks of vaginal mesh exposure (RR 3.75, 95% CI 1.42 to 9.86), bladder/urethral erosion (RR 17.79, 95% CI 1.06 to 298.88) and operative blood loss (mean difference 18.79, 95% CI 3.70 to 33.88). Postoperative pain was less common with single-incision slings (RR 0.29, 95% CI 0.20 to 0.43), and rates of long-term pain or discomfort were marginally lower, but the clinical significance of these differences is questionable. Most of these findings were derived from the trials involving TVT-Secur: Excluding the other trials showed that high risk of incontinence was principally associated with use of this device (RR 2.65, 95% CI 1.98 to 3.54). It has been withdrawn from clinical use.Evidence was insufficient to reveal a difference in incontinence rates with other single-incision slings compared with inside-out or outside-in transobturator slings. Duration of the operation was marginally shorter for single-incision slings compared with transobturator slings, but only by approximately two minutes and with significant heterogeneity in the comparison. Risks of postoperative and long-term groin/thigh pain were slightly lower with single-incision slings, but overall evidence was insufficient to suggest a significant difference in the adverse event profile for single-incision slings compared with transobturator slings. Evidence was also insufficient to permit a meaningful sensitivity analysis of the other single-incision slings compared with transobturator slings, as all confidence intervals were wide. The only significant differences were observed in rates of postoperative and long-term pain, and in duration of the operation, which marginally favoured single-incision slings.Overall results show that TVT-Secur is considerably inferior to retropubic and inside-out transobturator slings, but additional evidence is required to allow any reasonable comparison of other single-incision slings versus transobturator slings.When one single-incision sling was compared with another, evidence was insufficient to suggest a significant difference between any of the slings in any of the comparisons made. AUTHORS' CONCLUSIONS: TVT-Secur is inferior to standard mid-urethral slings for the treatment of women with stress incontinence and has already been withdrawn from clinical use. Not enough evidence has been found on other single-incision slings compared with retropubic or transobturator slings to allow reliable comparisons. Additional adequately powered and high-quality trials with longer-term follow-up are required. Trials should clearly describe the fixation mechanism of these single-incisions slings: It is apparent that, although clubbed together as a single group, a significant difference in fixation mechanisms may influence outcomes.

High risk of complications with a single incision pelvic floor repair kit: results of a retrospective case series.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to retrospectively assess the extent and severity of the post-operative complications associated with the Pinnacle Pelvic Floor Repair Kit. METHODS: This is a descriptive analysis of 23 consecutive women who had a prolapse repair with either an anterior (n = 19) or posterior (n = 4) Pinnacle kit. The clinical records of all these patients were available for analysis. Pre-operative data and intra-operative complications were noted. All post-operative complications and repeat surgical interventions were recorded. In addition to pelvic floor symptoms, we looked specifically for pelvic pain and mesh contraction, exposure, extrusion or erosion. Complications were classified according to the joint IUGA/ICS system. RESULTS: Seventy percent (n = 16) of our cohort experienced at least one complication. All, except one, were following an anterior Pinnacle. 10 patients (43 %) had a tender vaginal mesh prominence, including a contraction band anteriorly or at the vaginal apex. Six (26 %) complained of associated buttock, groin or vaginal pain, while the tenderness was only detected during vaginal examination in 4 (16 %) patients. Three (13 %) patients required vaginal mesh excision for severe pain and one required a second procedure. Three patients (13 %) had vaginal mesh exposure and 8 (35 %) developed de novo stress incontinence. Two patients (8 %) developed symptomatic recurrent prolapse, one following mesh excision owing to large mesh exposure. Another patient had an anterior compartment prolapse above and below a tender contracted anterior vaginal mesh. CONCLUSIONS: The Pinnacle kit was associated with a high incidence of post-operative complications in this small series.