Urethral bulking agents for the treatment of stress urinary incontinence in women: A systematic review.

AIMS: To perform a systematic review to assess and compare the efficacy and safety of all urethral bulking agents (UBAs) available for the treatment of stress urinary incontinence (SUI) in women. METHODS: This systematic review was conducted in accordance with the PRISMA guideline. A systematic search was conducted using the Ovid Medline, Embase and PubMed databases. Studies were included if they involved women who underwent either Bulkamid®, Macroplastique®, Durasphere®, Coaptite®, or Urolastic® injections for the treatment of SUI. A total of 583 articles were screened with 56 articles included. A qualitative analysis was performed. RESULTS: The newer synthetic UBAs are not inferior to Contigen®, with variable mean success rates of 30%-80% in the short-term. Better long-term success rates were found with Bulkamid® (42%-70%), Coaptite® (60%-75%), and Macroplastique® (21%-80%) on qualitative review. Urinary tract infection rates were similar between bulking agents (4%-10.6%) although temporary acute urinary retention was more commonly associated with Coaptite® (mean: 34.2%), and de novo urgency in Durasphere® (mean: 24.7%). Significant complications such as migration into lymph nodes was reported with Durasphere®. Erosion was reported with Macroplastique®, Coaptite®, and Urolastic®, with a rate as high as 24.6% in one study of Urolastic®. CONCLUSION: Available data support the use of Bulkamid® and Macroplastique®, which has shown a short-term efficacy of 30%-90% and 40%-85% respectively, and long-term efficacy of 42%-70%, and 21%-80%, respectively. Bulkamid® appears to have a more favorable safety profile, with no cases of erosion or migration of product associated with its use. Direct comparisons of UBAs have not been performed.

Safety and efficacy of polydimethylsiloxane (Macroplastique®) in women with stress urinary incontinence: analysis of data from patients who completed three years follow-up.

INTRODUCTION AND HYPOTHESIS: This study aimed to report 3-year completed follow-up of the safety and efficacy of Macroplastique® (MPQ) in women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). METHODS: This is a retrospective analysis of all women who completed 3-year follow-up post-MPQ injection(s) at ten medical centers. We used the ROSE registry data report of Macroplastique® [Macroplastique® Real-time Observation of Safety and Effectiveness (ROSE) registry P040050/PAS001 on 2017]. Subjective incontinence outcome and adverse effects were assessed. RESULTS: The study included all patients (n = 70) who completed 3-year follow-up after the last MPQ injection. Twenty-four of 70 (34%) patients had two injections; 21/70 (30%) patients reported Stamey grade 0 and 28/70 (40%) reported Stamey grade 1. The overall patient satisfaction was 68% who completed 3-year follow-up. The composite success rate (I-QoL, PGI-S, and Stamey grade improvement) was 51.4%. No serious adverse events (AE) were reported within the completed 3-year follow-up. CONCLUSIONS: MPQ was found to be safe and efficacious for the treatment of SUI secondary to ISD in women. The overall high satisfaction rate was sustained from baseline to 3 years post-injection. Most complications were minor and transient without sequelae.

Intraurethral bulking agents for the management of female stress urinary incontinence: a systematic review.

INTRODUCTION AND HYPOTHESIS: The object of this review was to assess the efficacy and safety of urethral bulking agents (UBA), principally Macroplastique and Bulkamid, in the treatment of female stress urinary incontinence (SUI). METHODS: MEDLINE® and EMBASE® databases were systematically searched up to June 2016. Year of publication, study type, outcome measures, urodynamics before and after the procedure, number of participants, procedure complications, proportion requiring repeat injections or surgical procedures, frequency of follow-up, and results were analysed. RESULTS: The use of Bulkamid and Macroplastique for the treatment of female SUI was described in 26 studies. Studies used modalities including the visual analogue scale, Likert scale, International Consultation on Incontinence Modular Questionnaire (ICIQ), Patient Global Improvement Questionnaire (PGIQ) and Incontinence Impact Questionnaire (IIQ) and showed success rates ranging from 66% to 89.7% at 12 months follow-up. Objective improvements in patient symptoms were measured using urodynamics, 24-h pad tests, cough tests and voiding diaries. Studies showed variable objective success rates ranging from 25.4% to 73.3%. Objective findings for UBAs remain less well documented than those for the midurethral sling procedure. CONCLUSIONS: There are a range of complications associated with UBAs, the most common being urinary tract infection. However, it remains a very well tolerated procedure in the majority of patients. UBAs should be considered as an alternative in patients unsuitable for more invasive procedures and those willing to accept the need for repeat injections. The majority of the literature focuses on subjective improvement measures rather than objective improvement measures. Further randomized controlled trials directly comparing UBAs are required to indicate the most effective agent.

Para-Urethral Injections with Urolastic® for Treatment of Female Stress Urinary Incontinence: Subjective Improvement and Safety.

INTRODUCTION: Female stress urinary incontinence (SUI) is often treated surgically. Urethral bulking agents are a minimally invasive alternative, especially in patients suffering from intrinsic sphincter deficiency, but often with limited long-term efficacy. Urolastic® is a non-deformable, non-resorbable silicone elastomer that is used as an injectable. Its properties might result in a more durable response after injection. If this durability factor can be combined with a low complication rate, this can become a useful treatment option. We therefore assessed the subjective improvement and safety after treatment with Urolastic®. MATERIALS AND METHODS: In 2 Dutch hospitals, 65 patients were treated with Urolastic®. The subjective improvement was assessed and the medical charts were reviewed for complications that appeared during the follow-up period. The complications were classified using the Clavien-Dindo classification. RESULTS: We found that 76-88% of the patients showed subjective improvement at 12-25 months follow-up. The rate of improvement experienced was 50-70%. The rate of complications classified as Clavien-Dindo >II was 24-33%. The 12 patients with 75-100% subjective improvement after 2 months, showed 85% improvement after a median of 25 months. CONCLUSIONS: With careful patient selection, Urolastic® seems to be a safe, durable and effective treatment option for female SUI.

Urethral bulking agents for the treatment of recurrent stress urinary incontinence: A systematic review and meta-analysis.

Recurrent stress urinary incontinence (rSUI) represents a major challenge for most clinicians as there is little evidence in the literature on the best option after sling failure. The objective of this study is to summarise the findings on the use of urethral bulking agents (UBAs) in the management of rSUI after the failure of a mid-urethral sling (MUSs). We performed a systematic review and meta-analysis, according to PRISMA 2020 guidelines, and selected eleven publications for inclusion in the analysis. We found that the overall cure and improvement rate ranged from 64% to 85% in the included studies, with a pooled value of 75%, compared with pooled failure and re-operation rates of 32% (95% CI: 22%-43%) and 25% (95% CI: 17%-34%), respectively. The I2 test indicated significant statistical heterogeneity among the studies in relation to all the outcome measures; however, no risk of publication bias was found. To explore this heterogeneity in more depth, we performed a sub-group analysis of the two most commonly used bulking agents (Bulkamid and Macroplastique). The pooled values of the cure and improvement rate were 84% (95% CI: 77.0%-90.0%) and 80% (95% CI: 74.0%-85.0%) for Macroplastique and Bulkamid, respectively. We did not find significant heterogeneity or significant differences in the outcome measures in either group. For the first time in literature, our study provides an insight into the use of UBAs after failed MUSs. Although the results seem very promising, future studies with shared protocols are needed in order to recommend the use of UBAs in the treatment of recurrent cases.

Imaging findings of vinyl dimethyl polydimethylsiloxane used as a paraurethral injectable for female stress urinary incontinence.

OBJECTIVES: Vinyl dimethyl polydimethylsiloxane (VDPDMS) is a urethral bulking agent used for female stress urinary incontinence (SUI), that is clearly visible on computed tomography (CT). Clinical effects are promising, but it remains difficult to identify factors predicting clinical success. Clinical outcome might depend on the shape and position of the implants after injection. Objective of this study is to analyze the appearance and position of bulk material on CT scans and to see whether it is delivered the intended circumferential and mid-urethral position. METHODS: A single-center retrospective study was performed in 20 women, treated with VDPDMS for SUI. A senior radiologist analyzed all CTs, using an assessment scheme. This scheme describes whether the bulk is scattered, mid-urethral, and/or circumferentially distributed. The imaging findings were subsequently correlated to the patient global impression of improvement (PGI-I) and the percentage of subjective improvement experienced 6 weeks post-operatively. RESULTS: The patient's mean age was 61 years, and they underwent median 2.0 previous surgical treatments for SUI. Three patients reported no improvement, 9 patients had 20-90% improvement and 8 reported >90% improvement of their SUI. In 17/74 (24%) positions, the implant was scattered rather than spherical. In 9/20 (45%), the implants were not located in the intended mid-urethral position. In 8/20 patients (40%), the material was distributed circumferentially. CONCLUSION: This is the first study describing the position and shape of VDPDMS in patients after treatment. The appearance and position of the implants appears to be variable, but optimal positioning or shape seems to be no absolute requisite for success.

Bladder neck and urethral erosions after Macroplastique injections.

AIMS: To evaluate the presentation, risk factors, diagnostic workup, management, and outcomes of Macroplastique (MPQ) erosions. METHODS: We performed a retrospective chart review of women experiencing MPQ erosion at two tertiary care centers (United States and United Kingdom). Data collected included age, presenting symptoms, parity, comorbidities, hormone replacement therapy, sexual activity, and smoking status. Previous surgical history, time from MPQ injection, urine culture results, and cystoscopic and imaging findings were also reviewed. Development of stress urinary incontinence (SUI) after MPQ removal and subsequent SUI treatments were recorded. RESULTS: From 2012 to 2018, 18 patients were identified with a median follow-up time of 24 months (interquartile range [IQR] 8-33). All patients presented with recurrent urinary tract infections (rUTI) and had cystoscopic evidence of MPQ erosion. The most common location of erosion was the bladder neck area (72%). Median time to presentation since MPQ injection was 14 months (IQR 11-35). The majority of patients (72%) had a previous history of anti-incontinence surgery. The overall success rate of endoscopic management defined as resolution of presenting symptoms including rUTI was 80%. The majority of patients (80%) developed recurrent SUI following MPQ resection with 33% requiring a subsequent autologous fascial sling placement. CONCLUSION: MPQ erosions present predominantly with UTI, sometimes years after the original injection, and may necessitate endoscopic management with satisfactory results in most patients. Following excision of MPQ, these patients are highly likely to experience SUI recurrence and need to be appropriately counseled. Some may require additional subsequent autologous fascial sling placement for treatment of their SUI symptoms.

Urethral bulking agent found in a urethral caruncle which did not respond to topical oestrogens: A case report.

BACKGROUND: Urethral caruncles are lesions occurring at the urethral orifice, around the posterior lip of the urethra. They are the most common benign growth of the female urethra. They are often asymptomatic and found incidentally on clinical examination. When symptomatic they commonly present with bleeding. Treatment includes vaginal oestrogens or, failing that, surgical excision. We present an unusual finding after excision of a urethral caruncle. CASE: A patient with a background of stress urinary incontinence had numerous pelvic surgeries, including colposuspension, tension-free vaginal tape (TVT) and Macroplastique (a urethral bulking agent). She developed bleeding from a 3 cm urethral caruncle, which did not improve with vaginal oestrogens. She proceeded to have a surgical excision of the caruncle. Histology revealed a foreign material with surrounding foreign-body-type multinucleate giant cell reaction. The material was compatible with Macroplastique. CONCLUSION: This case report describes an unusual and unexpected histological finding. Macroplastique is injected in the urethra, 10-15 mm from the bladder neck. We suspect the caruncle dragged the Macroplastique material out through the urethral meatus. If urethral caruncles are not adequately treated with vaginal oestrogens, surgery should be considered.

Polydimethylsiloxane Erosion as a Cause for Recurrent Urinary Tract Infections.

Background: Urethral bulking agents are commonly used for the management of stress urinary incontinence (SUI). Little long-term data exist for these agents, with few reports of migration or urethral erosion. Case Presentation: We describe a unique case of a woman who received a midurethral sling 3 years after receiving an injection of the urethral bulking agent, polydimethylsiloxane, because of persistent SUI. Her subsequent recurrent urinary tract infections led to the identification of a bladder neck erosion of the urethral bulking agent with a concomitant calcification. Conclusion: When irritative voiding symptoms are experienced in patients who have received urethral bulking agents, erosion must be considered. Furthermore, little is known regarding the definitive management of SUI in patients that have previously received an injection of a urethral bulking agent.

Face, Content, and Construct Validations of Endoscopic Needle Injection Simulator for Transurethral Bulking Agent in Treatment of Stress Urinary Incontinence.

INTRODUCTION AND OBJECTIVES: Endoscopic injection of urethral bulking agents is an office procedure that is used to treat stress urinary incontinence secondary to internal sphincteric deficiency. Validation studies important part of simulator evaluation and is considered important step to establish the effectiveness of simulation-based training. The endoscopic needle injection (ENI) simulator has not been formally validated, although it has been used widely at University of California, Irvine. We aimed to assess the face, content, and construct validity of the UC, Irvine ENI simulator. METHODS: Dissected female porcine bladders were mounted in a modified Hysteroscopy Diagnostic Trainer. Using routine endoscopic equipment for this procedure with video monitoring, 6 urologists (experts group) and 6 urology trainee (novice group) completed urethral bulking agents injections on a total of 12 bladders using ENI simulator. Face and content validities were assessed by using structured quantitative survey which rating the realism. Construct validity was assessed by comparing the performance, time of the procedure, and the occlusive (anatomical and functional) evaluations between the experts and novices. Trainees also completed a postprocedure feedback survey. Effective injections were evaluated by measuring the retrograde urethral opening pressure, visual cystoscopic coaptation, and postprocedure gross anatomic examination. RESULTS: All 12 participants felt the simulator was a good training tool and should be used as essential part of urology training (face validity). ENI simulator showed good face and content validity with average score varies between the experts and the novices was 3.9/5 and 3.8/5, respectively. Content validity evaluation showed that most aspects of the simulator were adequately realistic (mean Likert scores 3.9-3.8/5). However, the bladder does not bleed, and sometimes thin. Experts significantly outperformed novices (p < 001) across all measure of performance therefore establishing construct validity. CONCLUSION: The ENI simulator shows face, content and construct validities, although few aspects of simulator were not very realistic (e.g., bleeding).This study provides a base for the future formal validation for this simulator and for continuing use of this simulator in endourology training.

Implantable Systems for Stress Urinary Incontinence.

Stress urinary incontinence (SUI), the involuntary urine leakage due to failure of the urethral closure mechanism, is a global health challenge with substantial human suffering and socioeconomic costs. Approximately 167 million male and female patients are predicted to suffer from SUI in 2018, worldwide. A wide range of surgical interventions are available for the treatment of SUI. Severe cases, however, usually require the implantation of artificial urinary sphincter devices. This review comparatively presents and analyzes the working principles, as well as the challenges, associated with the current implantable SUI systems in clinical use. These include slings, urethral bulking agents, artificial urinary sphincters, and adjustable continence devices. It further reports on recent research progress and state-of-the-art in the field of SUI implants, including an original approach proposed by the authors with a pressure feedback sensory mechanism. The new emerging field of artificial muscle devices, including electroactive polymers, provides a promising innovative solution for replacing the weakened urethral sphincter in SUI patients.

Cross-sectional imaging following surgical interventions for stress urinary incontinence in females.

Stress urinary incontinence (SUI) is a condition in which the weakness of the pelvic floor muscles causes unintentional loss of urine. For patients who are unable to achieve symptomatic improvement from lifestyle modification and pharmacotherapy, surgical placement of the pelvic slings or the use of urethral bulking agents has been shown to provide tremendous symptomatic improvement. Learning to recognize the pelvic slings and to identify their complications on imaging is invaluable; however, this is challenging because of the change in the local anatomy after surgical placement of the sling. In this paper, we present CT and MR imaging to demonstrate the surgical and non-surgical treatments of female SUI and their complications. Through this pictorial essay, our goal is to familiarize radiologists with recognizing the various forms of treatment for SUIs, the relevant pelvic anatomy, and complications that may occur secondary to the surgical placement of the pelvic slings.

Urolastic for the treatment of women with stress urinary incontinence: 24-month follow-up.

INTRODUCTION: To evaluate the efficacy and durability of Urolastic, a new urethral bulking agent in women with stress urinary incontinence (SUI), after a follow-up of 24-months. MATERIAL AND METHODS: A follow-up study of women with SUI who received a Urolastic injection and successfully passed the 12-month follow-up. Assessment included the Stamey Grade, 1-h Pad weight test, and the International quality of life (I-QoL) score. RESULTS: Nineteen women who completed the 12-month follow-up were invited for the 24-month follow-up study. One patient did not respond to the correspondence. Four of the 18 patients who responded to the correspondence reported removal of the Urolastic implant at another facility, based on their desire. The explanation for this removal was painful intercourse (n = 1) or less than optimal dryness (n = 3). The overall objective improvement in continence status at 24-months was 66% compared to the 89% at the 12-month follow-up, while in addition the 1-h pad weight test showed >50% reduction in pad weight in 66% of patients compared to 84% at the 12-month follow-up. Adverse events reported were urinary tract infection (n = 1), local genital infection with erosion into the vagina (n = 1), painful intercourse (n = 2), and urgency (n = 4). CONCLUSIONS: Urolastic is comparable to other bulking agents in terms of durability, efficacy, and complications.

The role of synthetic slings in male stress incontinence.

OBJECTIVE: Our primary aim was to compare the outcomes of synthetic bone-anchored male slings (BAMS) and transobturator male slings (TOMS), to identify preoperative risk factors for failure, and to evaluate patient satisfaction with each procedure. PATIENTS AND METHODS: Charts were reviewed retrospectively of patients who underwent synthetic BAMS or TOMS from 2000 to 2011. Data were categorised into groups based on outcomes of 'dry', 'improved' and 'failure'. Success was defined as completely dry or an improvement by >50% in daily pad use. The data analysed included demographics, daily pad use before and after surgery, previous urethral insult, type of prostatectomy, and urodynamic study variables. Data were analysed using logistical regression, the t-test and chi-square analysis, where appropriate. RESULTS: Sixty-eight men were analysed (30 in each group; eight patients were excluded). Daily pad use for the TOMS group changed from 3.5 before to 1.5 after surgery (P = 0.001), whilst the BAMS group was unchanged from 3.9 to 3.5 (P = 0.747). The TOMS group had a success rate of 23/30 (77%) and a mean (SD) patient global impression of improvement score of 1.67 (0.90), whilst the BAMS group had a success rate of 11/30 (37%) and mean (SD) score of 2.64 (1.12). Urethral insult (P = 0.001) and preoperative pad use (P = 0.047) were significant predictors of failure. CONCLUSION: TOMS gave better outcomes than BAMS in both performance and patient satisfaction. Patients with a greater severity of incontinence and evidence of urethral insult before surgery should be counselled about the likelihood of suboptimal outcomes with any type of sling placement.