Urethral Bulking Agents Research Articles

6 - Novel method to prevent post operative urinary retention after urethral bulking agent: Pre-procedure sensorimotor training using sniff-enhanced respiration.

6 - Novel method to prevent post operative urinary retention after urethral bulking agent: Pre-procedure sensorimotor training using sniff-enhanced respiration.

Urethral Bulking Agents for the Treatment of Urinary Incontinence: Efficacy, Safety, and Impact on the Overactive Bladder Symptoms with an Underlying Detrusor Overactivity.

Background: Mixed urinary incontinence (MUI) has always represented a major therapeutic challenge and the management of this type of incontinence is often complicated by uncertain outcomes. Surgical options include interventions targeting both stress urinary incontinence (SUI) and urge urinary incontinence (UUI), although there are no international published guidelines that dictate whether it is better to start with surgical management to address the SUI or UUI component after the failure of conservative treatment. The aim of the present study is to evaluate the effectiveness of the Macroplastique (MPQ) procedure on overactive bladder (OAB) symptoms in women with MUI with a minimum follow-up of 1 year. Methods: A retrospective analysis of prospectively collected data was performed in two tertiary reference centers. We enrolled all women complaining of symptoms of SUI and OAB, dry or wet, with a urodynamically confirmed diagnosis of MUI [urodynamic stress incontinence (USI) with detrusor overactivity (DO)], who took a previous ineffective antimuscarinic treatment and underwent the MPQ procedure. We considered as objectively cured women who did not leak urine during the stress test and with a 1 h pad-test negative, while International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ICIQ-OAB, Patient Global Impression of Improvement (PGI-I) scale, and a Visual Analogue Scale (VAS) were used to assess subjective outcomes. Results: A total of forty-six patients who met the inclusion criteria and who underwent the MPQ procedure were considered for the analysis. At the 1-year mark of follow-up, 72% of patients were objectively cured at stress test and 65% were objectively cured at pad-test, while 72% of women declared themselves subjectively cured. OAB symptoms significantly improved after MPQ and a complete resolution of OAB was recorded in 35% of patients. Conclusions: This study demonstrated that MPQ is a safe and effective option for the treatment of female MUI. Furthermore, MPQ significantly improves the symptoms of OAB and is able to completely cure this condition in a relevant percentage of women with MUI when pharmacological treatment fails.

Long-Term Outcomes of Tension-Free Vaginal Tape Obturator: Efficacy and Safety at Long-Term Follow-Up

Background/Objectives: The use of tension-free vaginal tape obturator (TVT-O) for the treatment of stress urinary incontinence (SUI) has been widely debated over the last decade due to the lack of evidence on its long-term outcomes. The aim of this prospective study is to assess, for the first time in the available literature, the efficacy and safety of TVT-O implantation in women with pure SUI over a 17-year follow-up period. Methods: We included all women who complained of pure SUI symptoms (confirmed urodynamically) and underwent the TVT-O procedure. An objective cure was defined as the absence of urine leakage during the stress test, while subjective outcomes were assessed by means of the International Consultation on Incontinence Questionnaire—Short Form (ICIQ-SF), the Patient Global Impression of Improvement (PGI-I) scale, and a Visual Analogue Scale (VAS). Results: A total of 70 patients who met the inclusion criteria underwent the TVT-O procedure. During the study period, no patients were lost to follow-up, and all women completed the last evaluation at the 17-year mark. At the 17-year mark of follow-up, 62 out of 70 patients (81.4%) were subjectively cured, and 56 out of 70 (80%) patients were objectively cured. These data do not reveal any significant variation in the surgical outcomes over the follow-up period. We recorded seven (10%) tape exposure (three occurred after 10 years and four after 17 years). Among these, one woman was symptomatic for dyspareunia and “hispareunia”. All patients with mesh exposure were treated with partial removal and re-suture of the vagina, but only one developed the recurrence of SUI that required a second treatment with a urethral bulking agent (UBA). In all other cases, women reported a complete resolution of symptoms without any worsening of the urinary continence. No significant bladder or urethral erosion was recorded. Conclusions: The 17-year evaluation of the TVT-O procedure has shown that it is a highly effective and safe option for the treatment of female SUI. Although there was an increased risk of tape exposure 17 years after implantation, no serious complications were reported, and no patient required the total removal of the sling.

Urethral Bulking.

This Clinical Practice Statement aims to provide clinicians with evidence-based guidance for the use of urethral bulking agents (UBAs) in the treatment of stress urinary incontinence (SUI). We conducted a structured search of the English literature published from January 1960 to November 2022. Search terms identified studies of both current and historic UBAs. Data extracted at the time of full-text review included type of study, research setting, number of participants, age group, bulking agent, primary outcome, secondary outcome, efficacy, and complications. One thousand five hundred ninety-four nonduplicate articles were identified using the search criteria. After limiting the article types to randomized control led trials, prospective studies, guideline documents, reviews, meta-analyses, and case reports of complications, 395 studies were screened. Based on our findings, we propose the following recommendations for clinicians when considering UBA: First, UBA is indicated in cases of demonstrable SUI. Intrinsic sphincter deficiency is not predictive of patient outcomes. Second, patients should be counseled on the risks, lack of long-term efficacy data, potential need for repeat injections, possible need for surgery for recurrent SUI, implications for future procedures, and pelvic imaging findings that may be observed after UBA. Third, UBA may be considered for initial management of SUI. Fourth, UBA is an option for patients with persistent or recurrent SUI after a sling procedure. Fifth, clinicians may prioritize UBA over surgery in specific patient populations. Sixth, polyacrylamide hydrogel demonstrates marginally improved safety and durability data over other available agents.

Reconstruction of Urethral Sphincter With Polyacrylamide Hydrogel.

Urethral bulking is an alternative to synthetic midurethral sling for the treatment of stress urinary incontinence (SUI) in women. Urethral bulking agents, which are injected in the submucosal tissues of the proximal urethra/bladder neck, have demonstrated less adverse effects with similar satisfaction rates but lower subjective and objective cure rates when compared with midurethral sling. Cystoscopic Reconstruction of External Sphincter Technique (CREST) is a novel technique, which reinforces the natural closure mechanism of the external urinary sphincter (EUS). The aim of the study was to provide safety and efficacy data for injecting polyacrylamide hydrogel (PAHG) in the components of the female EUS. This was a retrospective chart review of patients using CREST with PAHG as initial treatment for SUI by a single surgeon from January 2022 to October 2022. Exclusion criteria are as follows: younger than 18 years, prior SUI surgery, concomitant pelvic organ prolapse or reconstructive procedure, neurological conditions, or history of radiation. Subjective and objective cure rates were measured by patient-reported symptoms and cough stress test. Urinary retention, postoperative urinary infection, and de novo urinary urgency were assessed. One hundred and thirteen consecutive patients met inclusion criteria with median follow-up of 3 months. Eighty-five percent of participants reported subjective improvement, 69% reported subjective cure, and 69% demonstrated objective cure. Nine patients reported transient postoperative retention, 8 reported postoperative urinary tract infections, and 5 reported de novo urgency. There were no serious adverse events. CREST is a novel technique for injection of PAHG, into the EUS to treat SUI. Our data suggest that this technique could improve urethral injection outcomes with minimal complications.

Current Treatment of Stress Urinary Incontinence by Bulking Agents and Laser Therapy-An Update.

Stress urinary incontinence (SUI) affects around 20% of women. In addition to the established suburethral sling insertion, two less invasive approaches are of interest today: urethral bulking agents and vaginal laser therapy. This review discusses articles through December 2023 identified by a PubMed literature search using the keywords "incontinence" and "bulking" or "laser". Although the two approaches are less effective than sling insertions, there are specific conditions in which one or the other technique is more advantageous. Injecting bulking agents into the urethra only takes some minutes and works without general anesthesia. The method is particularly suited for elderly, frail, or obese patients with multiple comorbidities, but is also applicable for all patients and in combination with other therapies. Generally, the safety profile is good but differs between bulking materials. Two laser types-the Erbium:YAG laser with SMOOTH-mode and the fractional ablative CO2 laser-deliver heat into the tissue to induce tissue tightening and regeneration. Intravaginal laser therapy improves mild to moderate SUI, while studies describe how intraurethral laser therapy is also beneficial for severe SUI. Young women between childbirths, as well as postmenopausal women, may benefit from laser therapy. The method is safe, can be performed on an outpatient basis, and does not require any artificial material.

Animal models, treatment options, and biomaterials for female stress urinary incontinence.

In the quest to tackle stress urinary incontinence (SUI), the synthesis of cutting-edge biomaterials and regenerative materials has emerged as a promising frontier. Briefly, animal models like vaginal distension and bilateral ovariectomy serve as crucial platforms for unraveling the intricacies of SUI, facilitating the evaluation of innovative treatments. The spotlight, however, shines on the development and application of novel biomaterials-ranging from urethral bulking agents to nano-gel composites-which aim to bolster urethral support and foster tissue regeneration. Furthermore, the exploration of stem cell therapies, particularly those derived from adipose tissues and urine, heralds a new era of regenerative medicine, offering potential for significant improvements in urinary function. This review encapsulates the progress in biomaterials and regenerative strategies, highlighting their pivotal role in advancing the treatment of SUI, thereby opening new avenues for effective and minimally invasive solutions.

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

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). A prospective clinical cohort study with 24 months follow-up. A tertiary academic hospital. Seventeen women with moderate to severe stress urinary incontinence (SUI). A retropubic MUS procedure with P4HB sling. 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. 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.

PD14-11 PERCUTANEOUS URETHRAL SPHINCTER STIMULATION: SWINE MODEL FOR FEASIBILITY OF USE IN STRESS URINARY INCONTINENCE

You have accessJournal of UrologyCME1 Apr 2023PD14-11 PERCUTANEOUS URETHRAL SPHINCTER STIMULATION: SWINE MODEL FOR FEASIBILITY OF USE IN STRESS URINARY INCONTINENCE Kyle Waisanen, Tyler Maiers, Peter Natalzia, and Teresa Danforth Kyle WaisanenKyle Waisanen More articles by this author , Tyler MaiersTyler Maiers More articles by this author , Peter NatalziaPeter Natalzia More articles by this author , and Teresa DanforthTeresa Danforth More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003261.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Current treatment modalities for stress urinary incontinence (SUI) include pelvic floor physical therapy, urethral bulking agents, and urethral sling support. We aim to assess direct electrical external urethral sphincter stimulation as a means for treating SUI patients with intrinsic sphincter deficiency. The objective of this study was to assess the feasibility of percutaneous external urethral sphincter access and urethral pressure profiles associated with direct electric sphincteric stimulation. METHODS: An IACUC-approved swine model study was performed under general anesthesia. The urinary bladder was accessed by open cystotomy for placement of antegrade 7F urethral pressure catheter. Stimulation leads were deployed into the external urethral sphincter under transvaginal ultrasound guidance and antegrade urethroscopy was performed to confirm urethral integrity. Leads were then stimulated with serial increases in amplitude from an external pulse generator from 0.1 mA to 3.6 mA with pressure monitoring of the external urethral sphincter. RESULTS: Three swine subjects were utilized in the study. All subjects underwent successful percutaneous insertion of stimulation leads into the EUS without urethral violation. External urethral sphincter pressures recorded with electric stimulation amplitudes of 0 mA, 1.8 mA, and 3.6 mA were found to exhibit increased urethral pressures of 6-10 cm H2O, 16-20 cm H2O, and 31-36 cm H2O, respectfully. EMG capture was achieved in each subject with a corresponding increase in EMG activity with pulse generator amplitude increase represented in the urodynamic strip from subject #2 (Figure 1). CONCLUSIONS: Direct external urethral sphincter stimulation with increased urethral closure pressures is achievable by an ultrasound-guided percutaneous approach. Further studies are required to assess long-term effects and success of the stimulation in SUI modeled subjects with promising results seen in this preliminary proof-of-concept study. Source of Funding: Lent Foundation, University at Buffalo © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e416 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kyle Waisanen More articles by this author Tyler Maiers More articles by this author Peter Natalzia More articles by this author Teresa Danforth More articles by this author Expand All Advertisement PDF downloadLoading ...

Factors associated with polyacrylamide hydrogel outcomes in women with stress urinary incontinence.

Knowledge of factors associated with superior outcomes in women treated with urethral bulking agents for stress urinary incontinence (SUI) remains limited. The aim of this study was to examine associations between post-treatment outcomes in women who had undergone polyacrylamide hydrogel injections for SUI, and physiological and self-reported variables captured during pre-treatment clinical evaluation. A cross-sectional study was undertaken in female patients treated for SUI with polyacrylamide hydrogel injections by a single urologist between January 2012 and December 2019. Post-treatment outcome data were gathered in July 2020 using the Patient Global Impression of Improvement (PGI-I), Urinary Distress Inventory-short form (UDI-6), Incontinence Impact Questionnaire (IIQ7), and International Consultation on Incontinence Questionnaire Short Form (ICIQ SF). All other data were gathered from women's medical records including pre-treatment patient-reported outcomes. Associations between post-treatment outcomes and pre-treatment physiological and self-reported variables were investigated using regression models. One hundred seven of the 123 eligible patients completed post-treatment patient-reported outcome measures. Mean age was 63.1 years (range 25-93 years), and median time between first injection and follow-up was 51 months (inter-quartile range 23.5-70 months). Fifty-five (51%) women had a successful outcome based on PGI-I scores. Women with type 3 urethral hypermobility pre-treatment were more likely to report treatment success (PGI-I). Poor bladder compliance pre-treatment was associated with greater urinary distress, frequency and severity (UDI-6 and ICIQ) post-treatment. Older age was associated with worse urinary frequency and severity (ICIQ) post-treatment. Associations between patient-reported outcomes and time between first injection and follow-up were trivial and not statistically significant. Severity of pre-treatment incontinence impact (IIQ-7) was associated with worse incontinence impact post-treatment. Type 3 urethral hypermobility was associated with a successful outcome, whereas pre-treatment incontinence impact, poor bladder compliance and older age were associated with poorer self-reported outcomes. Long-term efficacy appears to hold in those who responded to initial treatment.

A diagnostic conundrum: Is it a periurethral diverticulum/cyst or a bulking agent (Bulkamid)?

Urethral bulking agents are commonly used to manage female stress urinary incontinence (SUI) as they have been suggested to be safe, efficacious, and a minimally invasive surgical option. Bulkamid is a newer bulking agent that has been introduced and promoted in the market for use. It is non-particulate in nature with high tissue biocompatibility, and consequently, it is difficult to differentiate between Bulkamid and a periurethral cyst on magnetic resonance imaging (MRI). This, therefore, presents a diagnostic dilemma. Here we describe two cases with previous injections of Bulkamid referred to our Centre for management of a presumed periurethral diverticulum based on MRI findings. Both patients were reviewed and examined in outpatient clinics with MRI findings discussed at MDT, further imaging was required. We found that a limited noncontrast computed tomography (CT) pelvis, followed by a voiding cystometrogram (VCMG), and then a repeat limited noncontrast CT pelvis effectively differentiated between Bulkamid and these presumed periurethral diverticulae. The theory behind this was that during micturition, the contrast would pass through to the urethral diverticulum and appear as high-density (bright) material within the periurethral region (the pre-VCMG was required to prove that any high-density material was due to the contrast and not pre-existing high-contrast material). A CT scan done in conjunction with a VCMG is likely to be more effective in differentiating between Bulkamid and a true periurethral diverticulum than an MRI scan. Appropriate diagnostic evaluation of periurethral lesions can lead to time-saving and cost-effective patient management as this will bypass the need for unnecessary investigations and possible unwarranted surgical intervention.

Update on Urethral Bulking for Stress Urinary Incontinence in Women.

Urethral bulking agents are an effective treatment for stress urinary incontinence in select females. The material and techniques used for urethral bulking are constantly evolving. With the introduction of several new agents, there is an ongoing debate over which agent is the most effective, durable, and safe. Current available bulking agents include Bulkamid®, Macroplastiue®, Durasphere®, Coaptite®, or Urolastic®. Each of these agents has its own biophysical properties that affect its efficacy and safety. Evidence evaluating bulking agents has increased over time but there is no definitive data that suggest superiority of one agent over another. The ideal urethral bulking agent for female stress incontinence has yet been identified. Currently available agents have acceptable short-term and medium-term efficacy with few adverse events.

Contemporary trends in the surgical management of urinary incontinence after radical prostatectomy in the United States.

To identify trends, costs, and predictors in the use of different surgical procedures for post-radical prostatectomy incontinence (PPI). We identified 21,589 men who were diagnosed with localized prostate cancer (PCa) and treated with radical prostatectomy (RP) from 2003 to 2017. The primary outcome was the incontinence procedure performances. Optum's de-identified Clinformatics® Data Mart Database was queried to define the cohort of interest. The average costs of the different incontinence procedures were obtained and compared. Also, demographic, and clinical predictors of incontinence surgery were evaluated by multivariable regression analysis. Of the 21,589 men with localized PCa treated with RP, 740 (3.43%) underwent at least one incontinence procedure during a median of 5 years of follow-up. In total, there were 844 unique incontinence procedures. Male slings were the most common procedure (47.5%), had an intermediate cost compared to the other treatment options, and was the first-choice treatment for the majority of patients (50%). The use of an artificial urinary sphincter (AUS) was the second most common (35.3%), but also was the most expensive treatment and was first-choice-treatment for 32.3% of patients. On multivariable analysis, metabolic syndrome related disorders, adjuvant/salvage radiation therapy as well as a history of neurological comorbidities were independently associated with an increased likelihood of incontinence surgery. The receipt of male slings increased and then subsequently decreased, while AUS utilization was stable, and the use of urethral bulking agents was uncommon. From a cost standpoint, AUS was the most expensive option. Finally, patient's comorbidity history and RP related factors were found to influence the choice for primary or subsequent PPI interventions.

This Month in Adult Urology

This Month in Adult Urology

Up-to-Date Procedures in Female Stress Urinary Incontinence Surgery: A Concise Review on Bulking Agents Procedures.

To avoid complications related to mid-urethral slings (MUS), alternative procedures to treat stress urinary incontinence (SUI), such as urethral bulking agents (UBAs) have been adopted. The aim of this review is to narratively report the efficacy and safety of UBAs for SUI treatment. For this review, research from PubMed and EMBASE was performed to evaluate relevant studies that were undertaken from January 2012 to January 2022. Nineteen prospective studies were included. Several definitions of subjective and objective success were adopted. At a follow-up of <24 months, significant improvement was widely observed, even if with a heterogeneous rate of success between 32.7–90%, and a reinjection rate of 8.3–77.3%. Compared with other procedures, MUS resulted as significantly superior to UBAs but was balanced by a higher complication rate. Acute urinary retention, urinary tract infection and de novo urgency, and other complications, such as injection site rupture, urethral erosion and particle migration have been described after UBAs. SUI after UBAs treatment resulted in improvements in all studies and can be considered a safe and effective option to treat SUI. However, homogenous and longer-term data lack, limiting general recommendations. Thus, larger RCTs evaluating long-term effects are required.

Treatment of mild to moderate stress urinary incontinence with a novel polycaprolactonebased bioresorbable urethral bulking agent

A fully bioresorbable polycaprolactonebased bioresorbable bulking agent was evaluated for safety and efficacy in female patients with mild to moderate stress urinary incontinence who attempted and failed prior pelvic floor muscle training. Fifty female subjects were treated by transurethral sub-mucosal injection. Safety was evaluated over a 24-monts follow-up period. At the 12-months visit, a cystoscopy was performed for visual inspection of the injected area. Efficacy was assessed with the same intervals with the Stamey Grading System (SGS) among others. Only 6/50 subjects reported transient mild adverse events. The results show for the SGS grade more than 55% of the participants had an improvement in SGS grade, 40% of whom were cured within the first 12 months after treatment. During the second year of follow- up the effect seems to falter with an improvement of 50% of the subjects of whom 25% were cured. The results of the study suggest that treatment of mild-tomoderate stress urinary incontinence with a bioresorbable PCL-based bulking agent is a safe and effective alternative to permanent bulking agents and intermediate treatment option before the use of the permanent midurethral sling.

PD24-07 FAILURE RATES OF BLADDER OUTLET SURGERIES FOR STRESS URINARY INCONTINENCE IN WOMEN WITH NEUROGENIC LOWER URINARY TRACT DYSFUNCTION: A MULTICENTER NEUROGENIC BLADDER RESEARCH GROUP STUDY DYSFUNCTION (NLUTD)

You have accessJournal of UrologyCME1 May 2022PD24-07 FAILURE RATES OF BLADDER OUTLET SURGERIES FOR STRESS URINARY INCONTINENCE IN WOMEN WITH NEUROGENIC LOWER URINARY TRACT DYSFUNCTION: A MULTICENTER NEUROGENIC BLADDER RESEARCH GROUP STUDY DYSFUNCTION (NLUTD) Javier Santiago, Min Soo Choo, Anne Cameron, Richard Mora, Evgeniy Kreydin, David A Ginsberg, Natalia Hernandez, Paola Bustillos, Rose Khavari, Stephanie Daignault-Newton, and John Stoffel Javier SantiagoJavier Santiago More articles by this author , Min Soo ChooMin Soo Choo More articles by this author , Anne CameronAnne Cameron More articles by this author , Richard MoraRichard Mora More articles by this author , Evgeniy KreydinEvgeniy Kreydin More articles by this author , David A GinsbergDavid A Ginsberg More articles by this author , Natalia HernandezNatalia Hernandez More articles by this author , Paola BustillosPaola Bustillos More articles by this author , Rose KhavariRose Khavari More articles by this author , Stephanie Daignault-NewtonStephanie Daignault-Newton More articles by this author , and John StoffelJohn Stoffel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002566.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We evaluated the outcomes of bladder outlet procedures for treating stress urinary incontinence (SUI) in female patients with neurogenic lower urinary tract dysfunction (NLUTD). METHODS: A retrospective multi-institutional study by the Neurogenic Bladder Research Group of female patients with NLUTD and SUI who underwent urethral bulking injection (UBI), pubovaginal sling (PVS), or artificial urinary sphincter (AUS) for (SUI) from 2012-2020 was performed via CPT and ICD-9 codes. Women undergoing concomitant bladder reconstruction or botulinum toxin (BTX) were included. The primary outcome was failure of bladder outlet procedure defined as return to pre-operative baseline SUI symptoms and/or needing additional surgical intervention for SUI. Time to failure were evaluated and multi-variable analysis for variables associated with failure were assessed. RESULTS: Thirty-five female patients were included with diagnosis of spinal cord injury (35%), spina bifida (28%), and bladder exstrophy, multiple sclerosis or auto-immune neuropathy, pelvic surgery, or a supra-pontine disorder. There were 20, 14, and 1 cases of UBI, PVS, and AUS, respectively with a median follow up of 363 days. The median age was 46 years. BTX was performed exclusively with UBI (50%) and bladder reconstruction was performed more with sling vs UBI (29% vs 0%, p=0.02). Focusing on UBI and PVS, failure rates and time to failure between procedures were not significantly different on Kaplan Meier curves at median follow up of 5 and 14 months, respectively (75% failure at median 4.8 months for UBI vs 71% at 7.3 months for PVS, p=1). 6-month failure rates were 59% and 50% for UBI and PVS. Failure was only associated with increasing age on multivariable analysis. Additional surgeries for continence were performed in 60% and 57% patients after UBI and sling, respectively. CONCLUSIONS: Urethral bulking agents and sling placement both demonstrated similarly low durability in managing SUI in NLUTD in this cohort, with the majority of patients requiring secondary surgeries for continence. This warrants further study to better understand factors impacting failure. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e417 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Javier Santiago More articles by this author Min Soo Choo More articles by this author Anne Cameron More articles by this author Richard Mora More articles by this author Evgeniy Kreydin More articles by this author David A Ginsberg More articles by this author Natalia Hernandez More articles by this author Paola Bustillos More articles by this author Rose Khavari More articles by this author Stephanie Daignault-Newton More articles by this author John Stoffel More articles by this author Expand All Advertisement PDF DownloadLoading ...

Long-term complications of bulking agents in the treatment of stress urinary incontinence: Results of a national survey

Introduction and Objectives: Bulking agents have been used for decades as an alternative treatment for patients with stress urinary incontinence who are not appropriate for surgery. Despite this their long-term complications are poorly documented and can be misdiagnosed. This paper presents a literature review and the results of a national survey of members of the Section of Female, Neurological and Urodynamic Urology (FNUU) of the British Association of Urological Surgeons (BAUS) identifying the common long-term complications of widely used bulking agents in clinical practice. Methods: Following a comprehensive literature review an electronic survey was sent to members of the BAUS Section of FNUU. Data included hospital trust, use of urethral bulking agents (including type), the approximate number of procedures performed and whether any long-term complications had been observed and managed in their practice. Long-term complications were defined as those arising more than 12 months after treatment. Results: The literature review revealed multiple case reports of complications secondary to bulking agent injection but no high-level evidence regarding frequency or severity. The survey revealed complications including granulomas, erosions, abscesses and misdiagnoses of urethral diverticula and calculi formation. 88% of urologists who responded to the survey had performed a urethral bulking agent injection and 51% of urologists had observed or treated a long-term complication, some many decades after injection. Conclusion: Patients should be made aware of possible long-term complications of what appears to be a minimally invasive procedure in order for them to make an informed choice about treatment options. Level of evidence: Not applicable

Deflux® (NASHATM/Dx) urethral bulking injections: Outcomes over a decade in women with stress urinary incontinence

Objectives: Urethral bulking injections are thought to be a low risk minimally invasive but temporary treatment option for women with stress urinary incontinence (SUI) with increasing prominence especially in the current era of the mesh controversy. However, little is known about their long-term effects. This study aims to evaluate the efficacy and long-term outcomes of Deflux®, a non-animal stabilised hyaluronic acid/dextranomer (NASHATM/Dx) gel, when used as a urethral bulking agent in the treatment of SUI in women. Methods: All women with SUI treated with Deflux® from 2001 to 2007 were analysed. The success rates, duration of efficacy and short- and long-term complications of the treatment were recorded. Results: A total of 142 women with a follow-up of up to 13 years (mean 8.8 years) were included. Subjective treatment success was achieved in 92/142 (65%) patients. In those who achieved continence, the mean efficacy was 4.7 years. Side effects were uncommon with 12 (6%) of 209 experiencing transient urinary retention and 11 (5%) of 209 experiencing pseudocyst formation. All pseudocysts were treated successfully with an incision and drainage under either general or local anaesthetic. Sixty (42%) of 142 patients went on to have subsequent definitive incontinence surgery, and Deflux® treatment was found not to have negatively impacted the operation. Conclusion: Deflux® urethral bulking injections appear to be efficacious and safe when used as a treatment for SUI in women with a longer duration of efficacy than previously thought and a low side effect profile. This study provides a valuable timeline to help manage the expectations of patients considering urethral bulking treatment. Level of evidence: 4

Prophylactic antibiotics for preventing infection after continence surgery in women with stress urinary incontinence.

Surgical options for treating stress urinary incontinence (SUI) are usually explored after conservative interventions have failed. Surgeries fall into two categories: traditional techniques (open surgery) and minimally invasive procedures, such as laparoscopic procedures, midurethral sling and injections with urethral bulking agents. Postsurgery infections, such as infections of the surgical site or urinary tract, are common complications. To minimise the risk of postoperative bacterial infections, prophylactic antibiotics may be given before or during surgery. OBJECTIVES: To assess the effects of prophylactic antibiotics for preventing infection following continence surgery in women with stress urinary incontinence. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov and WHO ICTRP; and handsearched journals and conference proceedings to 18 March 2021. We also searched the reference lists of relevant articles. We included randomised controlled trials (RCTs) and quasi-RCTs assessing prophylactic antibiotics in women undergoing continence surgery to treat SUI. Two review authors selected potentially eligible trials, extracted data and assessed risk of bias. We expressed results as risk ratios (RR) for dichotomous outcomes and as mean differences (MD) for continuous outcomes, both with 95% confidence intervals (CIs). We assessed the certainty of evidence using the GRADE approach. We identified one quasi-RCT and two RCTs, involving a total of 390 women. One study performed retropubic urethropexy surgery requiring a transverse suprapubic incision, while the other two studies performed midurethral sling surgery. It should be noted that none of the included studies clearly specified the timing of outcome assessment. We are very uncertain whether prophylactic antibiotics (cefazolin) have an effect on surgical site infections (RR 0.56, 95% CI 0.03 to 12.35; 2 studies, 85 women; very low-certainty evidence) or urinary tract infections or bacteriuria (RR 0.84, 95% CI 0.05 to 13.24; 2 studies, 85 women; very low-certainty evidence). The effect of prophylactic antibiotics (cefazolin) on febrile morbidity is also uncertain (RR 0.08, 95% CI 0.00 to 1.29; 2 studies, 85 women; very low-certainty evidence). We are very uncertain whether prophylactic antibiotics (cefazolin) have any effect on mesh exposure (RR 0.32, 95% CI 0.01 to 7.61; 1 study, 59 women; very low-certainty evidence). None of the three included studies described the assessment of adverse events from antibiotic use, sepsis or bacteraemiain their reports. Only limited data are available from the three included studies and, overall, the certainty of evidence was very low. Moreover, the three included studies evaluated different surgical procedures and dosages of antibiotic administration. Thus, there is insufficient evidence to support or refute the use of prophylactic antibiotics to prevent infection following anti-incontinence surgery. In addition, there were no data regarding adverse effects of prophylactic antibiotics. More RCTs are required.