Management Of Stress Urinary Incontinence Research Articles

Ongoing Research for Managing Stress Urinary Incontinence in Women with a FDA Approved Device, The FemCap™

Background: The previous successful pilot study led the inventor to expand into Sweden and increase the number of participants. We also expanded the research comparing the FemCap to other Pessaries on the market. Pessary treatment is conservative with significant limitations. These limitations include displacement, erosion, ulceration, and urethral obstruction. Stress urinary incontinence (SUI) is prevalent particularly among menopausal women. The first line of SUI treatment is the ring pessary however, a variety of different pessaries have been introduced into the market with hope of achieving better results. Objectives: To provide women with a safer, more effective device to treat SUI. Materials and Methods: The FemCap combines the features of the ring and space- occupying pessaries into one device, which makes it more successful. The Bowl of the Dome of the FemCap covers the cervix and prevents it from prolapsing. The Rim fits snugly into the vaginal fornices that supports the bladder neck. The Brim flares outward pushing against the cystocele and urethrocele anteriorly to restore the anatomy of the urethra and the bladder. We recruited 118 women who had significant SUI and asked them to compare their experience for one week before using the FemCap and one week after. The FemCap was self-inserted and removed by the participants. Results: Only 100 women completed the study 94 were completely dry after one week, while 6 women were not satisfied with the results. No side effects were reported by the participants and pelvic examinations did not show any erosion or ulceration of the vagina. Conclusion: The FemCap is safe and effective in restoring the anatomy of the bladder, and urethra, which could make it ideal for the treatment and prevention of mild to moderate SUI. More studies are warranted to further prove the utility of the FemCap to manage SUI.

Short and Long Term Follow up and Efficacy of Trans Obturator Tape for Management of Stress Urinary Incontinence.

Stress urinary incontinence (SUI) is involuntary leakage of urine on raised intra- abdominal pressure which adversely affects quality of life usually requiring surgical treatment. This is a prospective study of efficacy, cure rates and complications of tension free transobturator tape (TOT) surgery on 85 women with SUI. Pre-operatively and 6months post-operatively International consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) scores were calculated for all patients to know the severity of incontinence and efficacy of tape. Mean age, parity, body mass index and mean duration of symptoms were 45.78years, 2.68, 26.38kg/m2 and 3.85years, respectively. SUI was demonstrated in all cases on cough stress test and Bonney's test. Mean operative time, blood loss, post-operative analgesic injections, post- operative stay and post- operative catheterisation were 23.28min, 45.50ml, 1.2 injections, 1.2days and 1.2days. Various complications noted were excessive bleeding (3.52%), urinary retention (7.05%), urinary urgency (8.23%), urinary tract infection (2.35%), surgical site infection (1.17%), groin pain (28.23%) and mesh exposure (3.52%). At 6 months follow-up, the complete cure rate was 83.52% , partial cure rate was 11.76% and failure rate was found to be 4.70% whereas it was 79.16%, 12.0% and 8.33% respectively at 3 years follow up. 2 patients (2.35%) required burch colposuspension and 12 patients (14.11%) required pelvic floor exercises and duloxetine therapy for their symptoms. Mean pre- operative ICIQ-SF score reduced post- operatively (17.8 ± 4.67 to 2.71 ± 1.42) (p value = 0.001). Study demonstrates short and long-term efficacy and safety of TOT for surgical management of SUI.

Autologous Fascial Slings for Surgical Management of Stress Urinary Incontinence: A Come Back.

Stress urinary incontinence (SUI) is a common type of urinary incontinence adversely affecting the quality of life of women. For mild SUI, life style changes, pelvic floor exercises and medical treatment with duloxetine may help. Most patients of moderate to severe SUI usually require surgical treatment. Various surgical treatment options include Kelly's plication, Burch colposuspension, bulking agents and sling surgeries. Although, suburethral fascial slings including the autologous rectus fascia slings were in vogue before 1990, they were overtaken by minimally invasive, faster and easier artificial midurethral slings (tension free vaginal tape and transobturator tape). However, observation of serious long-term and life changing complications of synthetic midurethral slings like mesh erosion, chronic pelvic pain and dyspareunia led to their adverse publicity and medico legal implications for the operating surgeons. This led US FDA (Food and Drug Administration) to issue a warning against their use. Currently, their use has significantly decreased in many countries, and they are no longer available in some countries. This has led to renaissance of use of natural autologous fascial sling, especially rectus fascia for surgical management of SUI. Although performing rectus fascia sling surgery is technically more challenging, takes longer, has more short-term morbidity like voiding dysfunction, their long-term success is high with very little risk of serious complications like mesh erosion, chronic pelvic pain and dyspareunia. However, multicentric trials and longer follow ups are needed before it's routine recommendation This review discusses the role of autologous fascial sling (especially rectus fascia) for the surgical management of SUI in the current time and the need of ongoing training of this procedure to gynecology residents and urogynecology fellows.

Коррекция недержания мочи после радикальной простатэктомии. Хирургическая техника шаг за шагом

Introduction. The main cause of stress urinary incontinence in men is prostate surgery - radical prostatectomy, transurethral resection of the prostate (TURP), enucleation, etc. The gold standard for the surgical treatment of urinary incontinence after prostate surgery is the implantation of an artificial urinary sphincter. For the treatment of mild/moderate urinary incontinence, implantation of synthetic urethral male slings is recommended. For the treatment of severe urinary incontinence, implantation of artificial urinary sphincter recommended. According to the Decree of the Moscow Government dated 12.24.2019 N 1822-PP, surgical interventions on the organs of the genitourinary system with the implantation of synthetic complex and mesh prostheses are included in the standards for the provision of high-tech medical care. Materials and methods. The paper presents a surgical technique for implantation of an artificial urinary sphincter model AMS 800 (Boston Scientific, Boston, MA, USA) and a male urethral sling AdVance XP (Boston Scientific, Boston, MA, USA). The indications for surgical treatment of stress urinary incontinence in men are listed, the criteria for selecting patients for the implantation of an artificial bladder sphincter and the installation of a urethral sling are described, and described in detail. Conclusion. The materials presented in the lecture will help urologists in mastering the technique of implantation of an artificial bladder sphincter and urethral sling in men.

Auto-rééducation pour le traitement de l’incontinence urinaire féminine : revue de la littérature

Literature review on the home-based options for the conservative management of stress urinary incontinence including biofeedback and weighted vaginal cones.. Research was conducted in the Cochrane Library and Pubmed to find articles, published until March 2020, dealing with the conservative management of incontinence. A total of 9 randomized controlled trials were included, 4 concerning biofeedback and 5 concerning vaginal cones. Most of them highlighted the superiority of these three methods compared to the absence of treatment but were not superior compared to the pelvic floor muscles training in the clinic setting. Home-based devices for female stress urinary incontinence is a safe and effective treatment for female urinary incontinence. It has not shown superiority to physiotherapist-guided pelvic floor muscle reinforcement and needs more evidence to gain its place as a first line therapeutic option.

A feasibility study with a novel, dynamic, and disposable over-the-counter device for the management of stress urinary incontinence.

This study aimed to evaluate the initial efficacy, safety, and usability of a novel, dynamic, and disposable intravaginal device in women suffering from stress urinary incontinence (SUI). Twenty-six women with SUI were recruited to perform a modified 1-h Pad Weight Gain (PWG) test. In this test, women drank 250-500 ml of water, were given a pre-weighed pad, and asked to perform a set of incontinence-inducing activities. At the end of the activities session, the pad was removed and weighed. This test was performed both with and without the Nolix device. Three efficacy endpoints measured were continuous percent reduction in urine leakage, dryness (defined as pad weight increase by no more than 1 g), and improvement in pad weight (measured as continuous percent reduction in PWG ≥ 50%). Any adverse events, reported by subjects during the device use were recorded. The usability and user's satisfaction were assessed using the Benefit, Satisfaction, and Willingness to Continue and Nolix Satisfaction questionnaires. The average reduction in PWG was 79.4%. The average reduction in urine leakage while using the device was at least 70%. In addition, in 79.5% of tests, the clinically meaningful level of improvement in PWG was achieved. Use of the device produced substantial improvement in the patient's perceived quality of life. No adverse events were reported during the study. The Nolix device served as a noninvasive, effective, and well-tolerated treatment option for reducing SUI in a modified 1-h PWG test with a set of incontinence-inducing activities.

“Mesh free” autologous transobturator mid urethral sling placement for predominant stress urinary incontinence: A pilot study

To assess the efficacy and safety of autologous mid-urethral sling (MUS) in women with predominant stress urinary incontinence (SUI). This prospective cohort study included adult women with predominant SUI seen in our urology clinic between January 2018 and March 2019. Patients with: negative cough stress test, history of prior incontinence surgery, urogenital malignancy, pelvic radiation, neurological disease, body mass index more than 40 kg/m2 , the presence of more than Stage I pelvic organ prolapse, active urinary tract infection, maximum flow rate less than 15 ml/sec, postvoid residual urine more than 100 ml, abdominal leak point pressure less than 60 cm of H2 O, and pregnant women were excluded. Eligible patients underwent a transobturator MUS procedure using rectus fascia as a sling. Before the procedure, patients filled the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptom (ICIQ-FLUTS) and the Female Sexual Function Index (FSFI) questionnaire. Urinary outcomes were assessed at 3- and 12-months while sexual outcomes were assessed at 12-months. Thirty patients with median age of 44.5 years were included. All patients had a negative cough stress test during follow up. A significant improvement was noted in the ICIQ-FLUTS scale, bother scale, filling and incontinence subscales at 3 and 12 month follow-up. A significant improvement was also noted in the FSFI full scale score and FSFI domains of mean sexual desire, arousal and lubrication at 12 months follow-up. Two patients developed voiding dysfunction requiring urethral dilatation. Autologous transobturator MUS surgery appears to be safe and efficacious in the short term. More research is needed to clarify its role in the surgical management of SUI in women.

Stress urinary incontinence in the mesh complication era: current Australian trends.

To examine available data relating to the surgical management of stress urinary incontinence (SUI) in Australia before, during and after a well-publicized Senate Inquiry into transvaginal mesh use and to consider outcomes in the context of global guideline changes. The annual number of surgical procedures for the management of SUI by procedure type and age group for the years 2008/2009-2017/2018 was obtained from the Australian Government Department of Human Services database using Medicare Benefits Schedule item numbers. The data extracted were limited to women aged 25years and older. These data were used to calculate age-specific and age-standardized rates, so as to accurately analyse trends in the usage of different procedures. Hospital Episode Statistics for mid-urethral sling (MUS) insertions were obtained for England's National Health Service from the Health and Social Care Information Centre for the years 2008/2009-2016/2017. These data were also used to calculate annual age-standardized rates for comparison purposes. Rates declined for most SUI procedures over time (MUS, colposuspension, fascial slings) except for urethral bulking agents. The absolute number of MUSs implanted in 2008/2009 was 5729, which decreased to 3127 in the 2017/2018 financial year. Over the decade, the annual rate for MUS implantation per 100000 population halved from 78 to 36. Over this same period, the rate of usage of bulking agents doubled, although represented a low volume of procedures (overall numbers increased from 304 to 698, representing an increase from four to eight procedures per 100000 population). The age-specific peak rate for MUS and Burch colposuspension changed over the decade from 55-64years to 65-74years, suggesting that women are deferring surgical treatment until later in life. Over the last decade, the total number of surgical procedures performed in Australia to treat SUI has decreased markedly from 6812 to 4279. This represents a decrease in the annual rate per 100000 population from 93 to 49. There are clear changes evident for SUI management in the past decade in Australia, including an overall decline in operative numbers, which correlate with international advisory notifications and local investigations. The results of the Australian Senate inquiry, including removal of single-incision mini-slings, greater availability of patient resources, and greater regulation of SUI procedures, will probably have ongoing effects. Surgeons need to ensure that sufficient training and patient education continue in order to maintain appropriate access to treatment of SUI in the future.

Stress urinary incontinence in men

Male stress urinary incontinence is predominantly iatrogenic, whereby radical prostatectomy is the most frequent cause. The first-line treatment of postoperative stress urinary incontinence is physiotherapy, in which training of pelvic floor muscles and sphincter play a major role. If conservative treatment fails surgical treatment is recommended. Nowadays, various options are available for the surgical treatment of stress urinary incontinence in men. Therefore, every patient with persistent postoperative urinary incontinence with psychological strain and desire for treatment should be offered surgical treatment. The selection of the surgical method should primarily be made depending on the contraindications.

Stress Urinary Incontinence I: Nonsurgical Management

Conservative management of stress urinary incontinence (SUI) is generally offered as first-line treatment. Such treatment options include behavioral therapy, pelvic floor muscle therapy, vaginal devices, pharmacologic therapy, and urethral bulking agents. Weight loss management is an example of an effective behavioral strategy in obese patients. Pelvic floor physical therapy alone or under the supervision of skilled providers can significantly improve SUI; however, long-term effects are harder to maintain. Pessaries, vaginal cones, and vaginal inserts have been widely used for treatment of SUI and are beneficial in patients who are motivated to use them. Currently in the United States, there is no FDA-approved medication for the treatment of SUI. Conversely, the European Union has approved and used duloxetine. Urethral bulking agents are indicated for patients with intrinsic sphincter deficiency and sometimes used in patients who are not able to undergo surgical procedures for SUI or who have failed said procedures. Three materials are currently FDA approved for urethral bulking in the United States. Many options exist for the nonsurgical management of SUI. This review contains 5 tables and 47 references Key words: Stress Urinary Incontinence, conservative treatment, urethral bulking, pelvic floor exercises, incontinence pessaries.

Managing Sphincter Deficiency Stress Urinary Incontinence in the Neurogenic Patient: Diagnosis and Management Strategies

In this review, we present the current literature on the diagnosis and management of stress urinary incontinence induced by sphincter deficiency associated with neurogenic lower urinary tract dysfunction. Because sphincter deficiency stress urinary incontinence is not a common condition, there are no guidelines or large-scale clinical studies that focus on the diagnosis and management of this condition. Although there is consensus that urodynamic investigation is the only method to assess the function of the lower urinary tract, there is no established urodynamic criteria to diagnose neurogenic sphincter deficiency. As for the treatment of sphincter deficiency stress urinary incontinence in neurogenic patients, artificial urinary sphincter has a better success rate and a higher complication and reoperation rate than other methods including sling surgery and injection of bulking agents. Although there is a progress in the evaluation and management of neurogenic patients with sphincter deficiency stress urinary incontinence, a prospective multicenter clinical study on this condition should be highly recommended.

Successful Management of Stress Urinary Incontinence in Women by a Contraceptive Device FemCap™ Pilot Study

Background: Women suffer silently from stress urinary incontinence (SUI). SUI is under-reported by women and under-diagnosed and treated by doctors. Treatment with pessaries is conservative and has significant limitations. These limitations include displacement, erosion, ulceration, and urethral obstruction. (SUI) is very prevalent among women of all ages, particularly menopausal women. The first line of SUI treatment is the ring pessary; however, more pessaries of different shapes and sizes have been introduced to achieve better results. Objectives: To provide women with a safer, more effective device to treat SUI. Materials and Methods: The FemCap combines the ring and space-occupying pessary features into one device, making it much more successful. The bowl of the dome of the FemCap covers the cervix and prevents it from prolapsing. The rim fits snugly into the vaginal fornices that support the bladder neck. The brim flares outward, pushing against the cystocele and the urethrocele anteriorly to restore the urethra and the bladder’s anatomy. Forty-one women who had had significant SUI were recruited and asked to compare their experience for one week before using the FemCap and two weeks later. The FemCap was self-inserted and removed by the participants. Results: Thirty-four women out of 41 were completely dry after two weeks of using the FemCap, while four women were partially dry, and three women did not notice any change. The participants reported no side effects, and pelvic examinations did not show any erosion or ulceration of the vagina. Conclusion: The FemCap is safe and effective in restoring the bladder and urethra’s anatomy, which could make it ideal for the treatment and prevention of mild to moderate SUI. More studies are warranted to prove the utility of the FemCap further to manage SUI.

Manœuvre de Bonney et ses dérivés : histoire, technique, signification et valeur pronostique

Historically a positive Bonney maneuver indicates the need for surgical management of stress urinary incontinence. This maneuver is regularly used in French daily practice without formal proof of its predictive value. A Medline search was performed with the terms "Bonney test" and "urinary incontinence" to include 10 relevant articles in this review. Eight articles study the mechanism of the maneuver or its derivatives, evoking a direct pressure on the urethra. Two studies are interested in the real predictivity of the maneuvers on the success of surgical treatment by urethral strip, reporting a positive predictive value of the Bonney maneuver between 96.2 and 100%. Further studies are needed to objectify the utility of this maneuver.

Single-incision mid-urethral mini slings versus standard transobturator slings in management of women with stress urinary incontinence: a randomized controlled trial

Purpose To evaluate the single-incision suburethral mini-sling (SIMS) versus the transobturator tapes (TOT) procedure in the management of stress urinary incontinence (SUI) regarding safety, efficacy, postoperative pain, and the time to return to daily activity. Patients and methods A total of 40 female patients with SUI were included in our study and were divided into two equal groups: group A was managed by TOT, whereas group B was managed by SIMS. Patients were evaluated from day 1 till 6 months after surgery for postoperative pain, early return to daily activity, dyspareunia, and continence after surgery. Moreover, also any perioperative complications were recorded. Results Patients’ demographics data were similar in both groups. We reported a success rate of 85% for patients of group A versus 80% success rate for patients in group B, with no statistically significant difference. A lower pain score in favor of group B was reported; these results were significant starting from day 1 till 1 month postoperatively, whereas at 3 and 6 months, the results were not statistically significant. Moreover, there was an earlier return to daily activity with group B compared with group A. We reported three cases of dyspareunia in group A compared with two cases in group B. No cases of vaginal erosions, as well as bladder, vascular, or vaginal injuries were encountered in our study. Conclusion The use of SIMS in the treatment of SUI is as effective and safe as TOT, with significantly lower postoperative pain and analgesic requirement and earlier return to daily activity.

Intérêt des applications mobiles et internet dans la prise en charge de l’incontinence urinaire d’effort chez la femme

Current recommendations for the management of stress urinary incontinence (SUI) include conservative interventions as first-line treatments. New approaches are emerging with the arrival of health applications on smartphones. The objective of this review is to evaluate the interest of mobile and Internet applications in the treatment of SUI in women. Interventional studies evaluating the use of mobile applications or websites in the management of women with SUI were selected from PubMed, Cinalh and PEDro databases. An analysis of symptoms, quality of life and adherence was carried out, highlighting biases. Eight of the 85 retrieved articles were selected. These studies report an improvement in SUI symptoms, quality of life and adherence after an intervention including new technologies (LE1). This type of intervention appears to be superior to the absence of intervention: patients report an improvement in symptoms (ICIQ-SF P<0.001; decrease in the number of pads P=0.023, LE1) and a greater perception of improvement (P<0.001, LE1). This type of intervention seems to be more effective than those in paper format on the decrease in the number of pads (P=0.02, LE1) and the perception of improvement (P=0.03, LE1). This innovative approach seems to reduce SUI symptoms, improve the quality of life and the functionality of pelvic floor muscles with long-term results. This type of intervention may improve adherence provided that it is associated with a treatment by a therapist.

Association Between Stress Urinary Incontinence and the Components of Metabolic Syndrome Among Females 20-59 Years

ObjectiveTo assess the relationship between stress urinary incontinence (SUI) and metabolic syndrome among a population-based cohort of women 20-59 years. MethodsNational Health and Nutrition Examination Survey database was used between the years of 2013 and 2016 and included women aged 20-59 years. SUI was defined as “Urinary leakage with physical activity.” Metabolic syndrome was defined as >2 risk factors: fasting blood glucose (FBG) >99 mg/dL, triglyceride >149 mg/dL, high-density lipoprotein <50 mg/dL, waistline >88 cm, and blood pressure >130/85. We generated weighted estimated prevalence and ran multivariable logistic regression models. ResultsAmong 3430 female subjects, the estimated prevalence of SUI was 38.7% (95% confidence interval [CI] 36.7-40.7%) and metabolic syndrome was 10.2% (95% CI 8.9-11.6). Higher rates of SUI were seen with large waistlines, elevated FBG, and elevated triglycerides. Among women with metabolic syndrome, 56.1% (95% CI 39.7-49.0%) had SUI. Among all women, metabolic syndrome and elevated FBG significantly increase the risk of SUI (odds ratio [OR] 1.53 [95% CI 1.02-2.28] and OR 1.86 [95% CI 1.14-3.03], respectively). In women 20-39 years, a large waistline significantly increased the risk of SUI (OR 1.72 [95% CI 1.00-2.99]). ConclusionAmong females 20-59 years in the United States, 38.7% report SUI and 10% have metabolic syndrome. Metabolic syndrome and an elevated FBG significantly increase the risk of SUI among all women. A large waistline increases the risk of SUI in women aged 20-39 years. Weight loss and adequate control of metabolic syndrome should be considered key strategies in the management of SUI.

A timeline of female stress urinary incontinence: how technology defined theory and advanced treatment.

Prevailing theories and treatments of female stress urinary incontinence are built on 120 years of evolution in understanding the structure and function of the female bladder neck and urethra and of considering why treatments failed. In our management of patients, it is important to understand and appreciate how our management of female stress urinary incontinence has evolved and which treatments have prevailed as we advance our knowledge for future treatments. The purpose of this review is to describe how advances in technology impacted and shaped prevailing theories or understanding of the pathophysiology of stress urinary incontinence and influences our treatment approach. An extensive literature search was performed from 1900 to present identifying articles that discussed technological advancements in female urology, theories of female stress incontinence, and treatments. The literature from the 20th century to the present shows a nonlinear evolution of the pathophysiological mechanism of stress urinary incontinence (SUI) from a notion of SUI and secondary to a simple anatomic finding to consideration of the effects of neurophysiologic pathways on SUI. Slings, however, have been a staple in the management of SUI. The pubovaginal sling (PVS) is a procedure that, with minor modifications (graft size, suture preference) has withstood the test of time and maintained its place in the armamentarium of SUI treatment for 100 years. It is therefore imperative that we continue to educate our residents and fellows on the surgical techniques and indications for use of the PVS.

Penoscrotal Incision for the Primary Implantation of an Artificial Urinary Sphincter

Background: The artificial urinary sphincter (AUS) has become the gold standard to treat severe stress urinary incontinence in men. The traditional placement of an AUS requires 2 incisions. The cuff is placed through a perineal incision and the reservoir and pump are placed via an inguinal incision. The implantation of an AUS is also possible via a single penoscrotal approach. Objectives: The objective is to demonstrate that the penoscrotal approach is not inferior to the perineal approach. Methods: Retrospective review of a single surgeon database from 2014 to 2019 was performed. A total of 40 patients have undergone implantation of an AUS via a penoscrotal incision. The outcome of patients was followed for an average of 31.3 months for adverse outcomes. Results: A primary American Medical Systems 800 sphincter was placed in 40 patients via a penoscrotal incision. The average age was 72 years. The average operating time was 35 minutes. The average cuff size was 4 cm. There were no infections of the prothesis so far. Three patients required a revision, 2 other patients needed an explant of the AUS, 1 patient underwent a cystectomy because of persistent radiocystitis. After activation of the sphincter, 33 patients (82.5%) were completely dry or using 1 pad per day for accidents. The remainder were all improved. Conclusions: AUS implantation via a single penoscrotal approach is not inferior to the perineal approach and has several advantages. The operating time is shorter and the procedure requires only 1 incision which both reduce the risk of infections, while the continence results are similar for both approaches.

Cost Analysis of Vaginal Anti-incontinence Procedures at a Tertiary Care Center

ObjectiveTo compare the cost of 3 vaginal procedures used in the surgical management of stress urinary incontinence (SUI) at 1 tertiary institution. MethodsThe costs of autologous fascial sling (AFS), synthetic mid-urethral sling (MUS), and anterior vaginal wall suspension (AVWS) were analyzed from a prospective long-term database, with follow-up to 5 years after these procedures. Original costing data were obtained for operating room, medical and surgical supplies, pharmacy, anesthesia supplies, and room and bed over 2 consecutive years. Included were complete cost data provided by our institution from Medicare (2012) and private payer insurance. ResultsFor the year 2013, the AVWS, AFS, and MUS had total median costs of $4513, $5721, and $3311, respectively. Total cost and all subcosts except for pharmacy costs were significantly different for each procedure. AVWS and MUS placement differed from each other regarding the cost of anesthesia and hospital stay, which was higher for AVWS. Compared to AFS, AVWS had significantly lower total costs due to decreased costs associated with operating time, hospital stay, and surgical supplies (P <.0001). At 5 years after these procedures, synthetic slings had less frequent follow-up visits. The most common revision for SUI failure was a bulking agent injection. ConclusionInitial costs of vaginal SUI procedures at our institution fared favorably compared to SUI procedures reported in the contemporary US literature. Long-term costs can vary based on physician preference in follow-up routine and etiology of SUI.

MP30-05 TRENDS IN INNOVATION IN THE SURGICAL MANAGEMENT OF STRESS INCONTINENCE AND PELVIC ORGAN PROLAPSE: A “DEEP DIVE” INTO THE FDA 510(K) AND PREMARKET APPROVAL DATABASES

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I (MP30)1 Apr 2020MP30-05 TRENDS IN INNOVATION IN THE SURGICAL MANAGEMENT OF STRESS INCONTINENCE AND PELVIC ORGAN PROLAPSE: A “DEEP DIVE” INTO THE FDA 510(K) AND PREMARKET APPROVAL DATABASES Cristina Fox* and MD Debra FromerMD Cristina Fox*Cristina Fox* More articles by this author and Debra FromerDebra Fromer More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000869.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In 2008, the FDA issued a landmark Public Health Notification (PHN) regarding adverse events of transvaginal mesh (TVM) for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In 2011, the FDA update stated that serious adverse events of TVM for POP repair are not rare. This same year, an FDA Executive Advisory Panel considered reclassification of TVM for POP repair from Class II (low to moderate risk) to Class III (high risk), which mandated a more extensive and costly Premarket Approval (PMA). The FDA followed with 109 orders for device manufacturers to initiate post-market 522 studies of existing TVM for POP repair and single-incision slings by 2013. In early 2016, up-classification of TVM for POP repair to Class III was announced along with a deadline of mid-2018 for PMAs and 522s. In April 2019 all TVM for POP repair were withdrawn from the market as the FDA revoked their clearance based on 1-year data. This series of events brings to question: how are the FDA regulatory clearance processes affecting trends in surgical innovation in the management of SUI and POP? METHODS: Utilizing the FDA 510(k) and PMA databases on the FDA website, we analyzed the trends of devices granted clearance for POP and SUI between 1999 and 2018. This included both modifications to existing devices and novel devices. Quantification of the number of novel device submissions during this study period was correlated to the FDA issued communications to estimate trends in device innovation. RESULTS: From 1999 to 2018, there were 127 total Cleared 510(k) Premarket Notifications, 48 for POP and 79 for SUI. Of the total submissions, there were 29 novel devices for POP and 40 for SUI. Figure 1 demonstrates a temporal analysis of submissions, correlating to a peak from 2004 to 2008, and accounting for 56% of all submissions. Conversely, post-2008, there is a precipitous drop in novel submissions, resulting in a literal flatline. CONCLUSIONS: The declining trend in device manufacturer innovation correlates with increasing demands from the FDA involving intensive premarket approval processes. Such a trend limits surgical options for women with POP and SUI and threatens the quality, evidence-based care that our patients deserve. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e439-e440 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Cristina Fox* More articles by this author Debra Fromer More articles by this author Expand All Advertisement PDF downloadLoading ...