Urethral bulking with Bulkamid: An analysis of efficacy, safety profile, and predictors of functional outcomes in a single-center cohort.

AIMS: The aim of the present work is to analyze the safety profile, effectiveness, and favorable and unfavorable predictors of clinical outcome in urethral bulking with Bulkamid, and to better identify the ideal candidate for the procedure. METHODS: We included all consecutive female patients treated with urethral bulking with Bulkamid at our institution within 2 years. Patients were affected by stress urinary incontinence (SUI) or mixed incontinence. Incontinence severity was classified as "mild" (urinary leakage <50 g/die), "moderate" (50-200 g/die), or "severe" (>200 g/die) at 24-hours pad test. Clinical success was defined as "dry" (no pads); clinical failure included "partial improvement" (>50% 24-hours pad test reduction) and "no benefit" (<50% 24-hours pad test reduction). The χ2 and Mann-Whitney tests were performed to assess the predictors of clinical outcome. RESULTS: The success rate was 36.1% (n = 35). Forty-three patients (44.3%) reported continence improvement. Complications included eight urinary retention cases (8.2%). Statistically significant correlation was observed between incontinence severity and clinical outcome in thee χ2 test (P = .008). No significant correlation was found between functional outcome and urodynamic incontinence features, postoperative urinary retention, previous pelvic surgery, age, and other physiological, pathological, and urodynamics characteristics. Urinary retention following the surgical procedure appeared to be related to clinical success with nonsignificant P value (P = .10). CONCLUSIONS: Bulkamid procedure could be proposed with good results in elderly patients or in patients requiring a low-invasive procedure with low risk of complications, affected either by SUI or mixed incontinence and with mild to moderate incontinence. Previous training to clean intermittent self-catheterization maneuver should be performed.

Assessment of perioperative, early, and late postoperative complications of the inside-out transobturator tape procedure in the treatment of stress urinary incontinence..

OBJECTIVE: To evaluate the complications of urinary incontinence surgery with transobturator tape (TVT-O) system and to describe its diagnosis and management. MATERIALS AND METHODS: A total of 156 patients who were diagnosed as having stress incontinence and mixed incontinence with stress predominance underwent a TOT operation under spinal anesthesia by one surgeon or two surgeons (MB, AEY) from the team. TVT-obturator inside out material was used in the operation. Urodynamic tests and pad tests were done on all the patients. This is a prospective and retrospective study of the complications of TVT-O. The operation was performed under regional anesthesia, as described by Deval et al. Patients were excluded from the study if they had been operated under general or local anesthesia, had undergone any vaginal operations except for anterior repair (cystocele), wanted to have a baby, had severe systemic diseases or had been diagnosed as having urge incontinence in urodynamic tests. These situations may affect the rate of complications, the authors also excluded slings that had materials other than monofilament polypropylene, and patients who were suspected of having neurologic bladder conditions. The bladder and urethra were evaluated using cystoscopy. The durations of the TOT procedure, cystoscopy, and if performed, the cystocele operation, were recorded. Perioperative, early, and late postoperative complications were analyzed by follow-up visits (after two months to four years). RESULTS: Of the 156 patients included in the study, 100 (64.1%) had pure stress urinary incontinence and 56 (35.9%) had mixed incontinence, 20 (12.8%) had previous incontinence surgery. The mean duration of follow up was 30.3 ± 7.4 (range 17-42) months. The mean age of the patients was found to be 48.43 ± 6.24 years (range 42-68). The mean parity of the patients was 5.24 ± 2.86 (range 2-13), and mean body mass index was found to be 23.7 ± 4.8. Mean maximum detrusor pressure was 10.30 ± 4.08 and the mean ALP value was 80.80 ± 25.57. Mean operative time was found to be 13.8 ± 5.16 min in patients who underwent only TOT and TOT-anterior repair. Vaginal injury including to the lateral fornix (4.4%), hemorrhaging of more than 200 ml (3.2%), vascular damage (1.9%), hematoma on the leg (1.9%), hemorrhaging of more than 500 ml (0.064%), and bladder perforation (1.2%) were detected as perioperative complications. Urethral injury and perioperative nerve and intestinal injury did not occur. The most common complication in early postoperative period was inguinal pain extending the legs (30.7%), followed by headaches (23.7%), fever (12.8%), urinary tract infection (5.7%), and urinary retention (3.2%), respectively. Late postoperative complications included vaginal erosion (4.4%), de novo urge incontinence (8.9%), de novo dyspareunia (7.1%), perineal pain (4.4%), and worsening urgency (8.9%). CONCLUSION: Although the TVT-O technique is a minimal invasive surgery method applied to treat the urinary incontinence surgically, it does not imply that it is a complication-free surgical procedure. Despite the low incidence of intraoperative complications, there is a mild risk of early and late postoperative complications. Fortunately these complications can be taken under control by either conservative and simple medical treatments or surgical procedures.

Surgical treatment for stress urinary incontinence.

The prevalence of stress urinary incontinence is quite significant with large numbers of women affected. Many of these women will not seek medical help in the belief that they will not be cured or improved. With the increasing numbers of procedures now available we present a review of both established and novel surgical techniques that is intended to help both urologists and primary care physicians in the counselling of patients complaining of stress incontinence. We compare the "gold standards" of surgical treatment for all types of stress incontinence with the newer techniques that have recently become popular among urologists and gynaecologists.

Thoughts on midurethral synthetic slings.

Since the early 1900s, there have been many attempts to correct stress urinary incontinence (SUI) in women. Over the years, it became accepted that the most effective way to correct SUI involved a procedure that supports the urethra. This simple premise spurred major innovations in the 1970s and 1980s by Shlomo Raz and Tom Stamey, many of which proved difficult to reproduce and were not universally accepted. In the mid-1990s, however, Ulf Ulmsten and Peter Petros revolutionized treatment of SUI, using a synthetic sling at the midurethra in a tension-free fashion. The urologic and urogynecologic world forever changed. In the last decade, further innovations have been based on these principles. There are currently three main types of synthetic sling procedures, including the retro-pubic synthetic sling, the obturator synthetic sling, and the single-incision synthetic sling.

Two Cases of Suspected Rejection of Polydimethylsiloxane Urethral Bulking Agent.

We report the cases of 2 women who had urethral bulking injections with polydimethylsiloxane for stress urinary incontinence with intrinsic sphincter deficiency and reported initial improvement of symptoms followed by rapid return of stress urinary incontinence several weeks later associated with extrusion of the bulking material. We hypothesize this unique adverse outcome could represent immune rejection of this urethral bulking agent.

Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence.

CONTEXT: Surgical nonautologous meshes have been used for several decades to repair abdominal wall herniae. Implantable materials have been adopted for the treatment of female and male stress urinary incontinence (SUI) and female pelvic organ prolapse (POP). OBJECTIVE: A consensus review of existing data based on published meta-analyses and reviews. EVIDENCE ACQUISITION: This document summarises the deliberations of a consensus group meeting convened by the European Association of Urology (EAU) and the European Urogynecological Association, to explore the current evidence relating to the use of polypropylene (PP) materials used for the treatment of SUI and POP, with reference to the 2016 EAU guidelines (European Association of Urology 2016), the European Commission's SCENIHR report on the use of surgical meshes (SCENIHR 2015), other available high-quality evidence, guidelines, and national recommendations. EVIDENCE SYNTHESIS: Current data suggest that the use of nonautologous durable materials in surgery has well-established benefits but significant risks, which are specific to the condition and location they are used for. Various graft-related complications have been described-such as infection, chronic pain including dyspareunia, exposure in the vagina, shrinkage, erosion into other organs of xenografts, synthetic PP tapes (used in SUI), and meshes (used in POP)-which differ from the complications seen with abdominal herniae. CONCLUSIONS: When considering surgery for SUI, it is essential to evaluate the available options, which may include synthetic midurethral slings (MUSs) using PP tapes, bulking agents, colposuspension, and autologous sling surgery. The use of synthetic MUSs for surgical treatment of SUI in both male and female patients has good efficacy and acceptable morbidity. Synthetic mesh for POP should be used only in complex cases with recurrent prolapse in the same compartment and restricted to those surgeons with appropriate training who are working in multidisciplinary referral centres. PATIENT SUMMARY: Synthetic slings can be safely used in the surgical treatment of stress incontinence in both male and female patients. Patients need to be aware of the alternative therapy and potential risks and complications of this therapy. Synthetic mesh for treating prolapse should be used only in complex cases with recurrent prolapse in specialist referral centres.

Prospective randomized controlled trial of extended-release oxybutynin chloride and tolterodine tartrate in the treatment of overactive bladder: results of the OBJECT Study.

OBJECTIVE: To compare the efficacy and tolerability of extended-release oxybutynin chloride and tolterodine tartrate at 12 weeks in participants with overactive bladder. SUBJECTS AND METHODS: The OBJECT (Overactive Bladder: Judging Effective Control and Treatment) study was a prospective, randomized, double-blind, parallel-group study conducted between March and October 2000 at 37 US study sites. Participants who had between 7 and 50 episodes of urge incontinence per week and 10 or more voids in 24 hours received extended-release oxybutynin, 10 mg/d, or tolterodine, 2 mg twice daily. The outcome measures were the number of episodes of urge incontinence, total incontinence, and micturition frequency at 12 weeks adjusted for baseline. RESULTS: A total of 315 women and 63 men were randomized and treated, and 332 participants (276 women, 56 men) completed the study. At the end of the study, extended-release oxybutynin was significantly more effective than tolterodine in each of the main outcome measures: weekly urge incontinence (P=.03), total incontinence (P=.02), and micturition frequency episodes (P=.02) adjusted for baseline. Both drugs improved symptoms of overactive bladder significantly from baseline to the end of the study as assessed by the 3 main outcome measures (P<.001). Dry mouth, the most common adverse event, was reported by 28.1% and 33.2% of participants taking extended-release oxybutynin and tolterodine, respectively (P=.32). Rates of central nervous system and other adverse events were low and similar in both groups. CONCLUSIONS: Extended-release oxybutynin was more effective than tolterodine as measured by end-of-study urge incontinence, total incontinence, and micturition frequency episodes. Both groups had similar rates of dry mouth and other adverse events.

Correlation of urodynamic results and urethral coaptation with success after transurethral collagen injection.

OBJECTIVES: We correlated preoperative urodynamic and intraoperative endoscopic findings with initial improvement, single collagen injection effectiveness for intrinsic sphincter deficiency (ISD), and long-term improvement following transurethral collagen injection for stress urinary incontinence (SUI). METHODS: Since 1993, 79 patients have been treated with transurethral collagen injection by the same urologist. Of these patients, intraoperative photographs of urothelial coaptation immediately after injection were available in 67 patients: 35 women with ISD, 24 men with incontinence, primarily following prostatectomy, and 8 children with neurogenic bladder. Urothelial coaptation was described as snug, fair, or poor. Preoperative Valsalva leak point pressure (VLPP), detrusor instability, impaired bladder compliance, bladder neck appearance, urothelial scarring, and degree of coaptation were correlated with both initial and long-term improvement. Initial improvement was compared with long-term improvement. RESULTS: Initial improvement was experienced by 85% of all the subjects (86%) of the women, 80% of the men, and 100% of the children with a neurogenic bladder condition). Overall, 31% of patients had long-term improvement after a mean follow-up of 2.2 years, including 43% of the women, 13% of the men, and 33% of the children. The patients underwent a mean of 1.5 (1 to 4) collagen injections. There was a significant correlation between degree of coaptation and initial improvement (P = 0.003), but not with long-term improvement. There was no correlation between VLPP detrusor instability, impaired compliance, bladder neck appearance, or urethral scarring and initial improvement. There was no correlation between any parameter and long-term improvement or between initial and long-term improvement. CONCLUSIONS: Initial endoscopic appearance following collagen injection predicted initial, but not long-term, improvement after one collagen injection. Initial improvement was high in both men and women but decreased considerably over time, more so in men, and was not significantly correlated with long-term success. Urodynamic and endoscopic findings do not predict long-term success following collagen injection.

Surgical treatment for female geriatric incontinence.

Surgery may be the most effective treatment for incontinence in the elderly female patient. Today, most of these incontinent patients are cured with surgery using the transvaginal approach, an access at low risk (especially for the geriatric female population). Surgery for stress urinary incontinence of all grades is established; however, surgical treatment for urge incontinence due to bladder instability is still controversial.

[Urinary stress incontinence in women]. / Stressharninkontinenz der Frau.

The integral theory of Petros and Ulmsten has profoundly changed our understanding of the female pelvic floor. Anatomic laxity of the vaginal wall caused by pelvic floor defects induced at different damage zones is frequently not only responsible for stress urinary incontinence but also for pollakisuria, urgency, post-void residual and pelvic pain. A number of minimally invasive techniques have been developed to correct these defects. Applying a tension-free polypropylene tape around the mid-urethra has become an established method to correct the anterior ligaments. The infra-coccygeal sacropexy can achieve dorsal stabilization of the vaginal wall. Currently, polypropylene meshes are increasingly used for repairing supporting pelvic fasciae. The most recommended conservative methods are exercises to strengthen the pelvic floor muscles. Duloxetine increases the rhabdosphincter contractility during the filling phases, but not during voiding, and therefore is a promising drug for clinical use.

Tension-free vaginal tape procedure for the treatment of stress urinary incontinence: the first experience in Thailand.

OBJECTIVE: Tension-free vaginal tape (TVT) is gaining popularity as an effective treatment for genuine stress urinary incontinence. To better understand this procedure including its results, a retrospective study was carried out to determine surgical technique, effectiveness, safety and early results of this new continence procedure. MATERIAL AND METHOD: From January 1999 to July 2000, twenty female patients with the mean age of 52 years old underwent the TVT procedure. All of them were done by a small incision at mid urethra and a special instrument was used to apply a polypropylene mesh supporting the urethra. Urethral catheter was used as urinary drainage which was removed the next day. Operative time, post-operative course, voiding patterns and residual urine were recorded. RESULTS: Mean operative time was 32 minutes (range 15-45 minutes). Up to 10 months, all of the patients were subjectively cured. There was no significant per- and post-operative complication including blood loss, wound infection and severe pain. Four patients (20%) had marked residual urine (>100 ml) and needed clean intermittent catheterization for the mean of 0.7 week. CONCLUSION: Although the follow-up period was short, the TVT procedure seems to be a safe and effective method for the treatment of stress urinary incontinence.

[The "hazards" of using a Gore-Tex sling in the treatment of stress urinary incontinence]. / Les "aléas" de l'utilisation d'une fronde de Gore-Tex dans le traitement de l'incontinence urinaire d'effort.

OBJECTIVE: To analyze the use of the Gore-Tex in the treatment of exertion incontinence. METHODS: During 1991, two gynecology units used the Mouchel technique and a Goebell-Stoeckel type technique in 72 patients with exertion incontinence, alone in 36 and in combination with a cure for prolapsus in 36 others. Results were analyzed with the chi 2 squared test and the Student's test for paired series. RESULTS: The rate of incontinence was 65% with a range from 60 to 66.7% according to the type of technique used and whether a cure for prolapsus was also performed. Gore-Tex was not well tolerated in 23/72 cases. Rejection was seen in 20 to 37.5% according to the type of vaginal suture and the type of protection. CONCLUSION: The high rate of rejection suggests prudence in using Gore-Tex.

The evolving role of submucosal injectables for treating internal sphincteric deficiency.

Each of the previously mentioned materials can be used in procedures performed on an outpatient basis using sedation and local anesthesia. Teflon usually requires general anesthesia. None of these materials, however, should be used in acute conditions involving cystitis, urolithiasis, or infection. Table 4 summarizes the postoperative care after a bulking agent injection. There are obvious advantages to using injectable materials for ISD, one of which is that the outpatient procedure is usually done under local anesthesia. It does not have the risks inherent in open surgical procedures like slings or artificial sphincters, and it causes minimal increase of urethral resistance to detrusor-generated micturition force. Such procedures are obviously easier and faster to perform with less cost and rapid recovery followed by a return to regular activity within 48 hours. In conclusion, injection therapy for urinary incontinence is appropriate, but the most effective substance has probably not yet been determined.

Treatment of elderly women with urge incontinence in middle tennessee: a single institution practice-based study.

INTRODUCTION AND OBJECTIVES: Urinary urge incontinence (UUI) is a major factor in reducing quality of life in elderly women. The treatment of UUI in the elderly population is complicated by comorbidities, polypharmacy, cost, and side effects. The purpose of this study was to examine our practice pattern in Middle Tennessee for the treatment of elderly women with UUI. METHODS: We retrospectively reviewed the medical records of all women over age 65 seen at our institution between January 1, 1998 and September 1, 1999 with an initial complaint of pure UUI. Diagnosis was based on history and physical examination by a single urologist (JJF). Initial treatment in all patients was medication as well as timed and double voids. Medication chosen was based on cost factors, co-morbidities, current medications, and outcome from previous treatment. RESULTS: Of 53 women ranging in age from 65-87 years of age (avg. 74.7) included in this study, 6/53 (11.3%) had a previous CVA, and 2/53 (3.7%) had grade I-II cystoceles. Initial pharmacologic treatment included anticholinergic medication in 47 patients (88.6%), and either imipramine or topical estrogen alone in the remaining 11.4%. Of the anticholinergics, hyoscyamine time capsules were used in 29, tolterodine in 7, standard oxybutynin in 5, oxybutynin XL in 1, and a combination with imipramine in 5. Thirty-four of the 53 total patients (64.1%) discontinued their medications because of no improvement 14 (41.1%), dry mouth 9 (26.4%), other side effects 9 (26.4%), cost 1, and other reasons in the remaining 2 patients. Only 17 patients (32%) stated they were doing well on their initial medications; 11 of those (64.7%) were taking hyoscyamine time capsules. Upon subjective failure, 22/36 patients (61.1%) had their medications changed, while 14/36 (38.8%) pursued behavioral therapy without additional medications. Urodynamic studies were done in 12 patients who failed empiric medical treatment (22.6%). CONCLUSIONS: Only 32% of elderly women treated medically for UUI were satisfied and continued therapy in this patient population. One-fourth of elderly women failed empiric medical management of UUI due to lack of efficacy, and one-third due to intolerable side effects. In this practice, hyoscyamine was continued more often than any other anticholinergic because of reasonable cost, efficacy, and side effect profile.

Do preoperative cytokine levels offer a prognostic factor for polypropylene mesh erosion after suburethral sling surgery for stress urinary incontinence?

When polypropylene meshes are used in reconstructive urogynecological surgery, the erosion rates vary from 3.3% to 14% and causative factors for such erosions are still unknown in many cases. Therefore, the aim of our study was to establish the role of immunologic factors in the process of polypropylene tapes erosions after suburethral sling procedures. Serum concentrations of tumor necrosis factor alpha, interleukin (IL)-2, IL-4, IL-5, IL-10, and interferon (IFN)-gamma were estimated in 123 patients suffering from stress urinary incontinence preoperatively and during 12 months follow-up using Human Th1/Th2 Cytokine Cytometric Bead Array I kit. The same immunological assessment was performed in each case of detected tape erosion. Statistical calculation was performed using UNIVARIATE, CORR, and NPAR1WAY procedures from Statistical Analysis System. The unpaired Student's t test, nonparametric Mann-Whitney U test, and Wilcoxon tests were used. Preoperative IFN-gamma concentration was significantly higher in women with subsequent polypropylene mesh erosion when compared to women with successful outcome (p < 0.05). Th1 cytokine profile may be related to the risk of the vaginal erosions following placement of polypropylene meshes. The way to lower erosion rate may involve exclusion of the patients immunologically prone to synthetic material erosion. The factor which can help to select such patients could be preoperative level of IFN-gamma.

Medium-term anatomic and functional results of laparoscopic sacrocolpopexy beyond the learning curve.

BACKGROUND: Limited prospective data on the anatomic and functional outcome after laparoscopic sacrocolpopexy (LSC) are available in the literature. OBJECTIVE: To describe the medium-term anatomic and functional outcome of LSC. DESIGN, SETTING, AND PARTICIPANTS: Prospective consecutive series of 132 women with vaginal vault prolapse undergoing LSC between 2001 and 2006, which was after our learning curve. Patients with urodynamically proven stress incontinence (SI) underwent a concomitant tension-free vaginal tape (TVT) procedure. INTERVENTION: Patients underwent LSC with a polypropylene implant. MEASUREMENTS: Principal outcome measures were anatomic cure (stage 1 or lower) assessed by the Pelvic Organ Prolapse Quantification (POPQ) system and subjective cure and impact on quality of life measured by a standardised interview and, since its introduction in 2004, by a prolapse-specific quality-of-life questionnaire (P-QOL). RESULTS AND LIMITATIONS: At a mean follow-up of 12.5 mo, the anatomic cure rate for the apex was 98%. Anatomic failures elsewhere were mainly at the posterior compartment (18%). Subjective prolapse cure rate was 91.7%, and no patients required reoperation for recurrent prolapse. Symptoms of preoperative SI, urge incontinence, or constipation were cured in 43%, 46%, and 42% of patients, respectively. The rate of de novo SI was 7.3%. De novo constipation developed in 5% and de novo dyspareunia developed in 19%. Patients' quality of life improved significantly. Erosions occurred in 4.5%, all within 1 yr. A limitation of the study is that the quality-of-life assessment score became available halfway through the study, limiting the number of preoperative observations (n=36). CONCLUSIONS: We demonstrated that LSC results in good anatomic outcome and subjective cure of prolapse symptoms at medium term. The posterior compartment was most vulnerable for recurrence.

Bulking agents for stress urinary incontinence: short-term results and complications in a randomized comparison of periurethral and transurethral injections.

The purpose of our study was to compare the two standard routes of urethral bulking injection in a prospective randomized trial. Forty women with genuine stress incontinence (n = 36), or mixed incontinence with a minor and controlled urge component (n = 4), participated in a urethral bulking agent trial. All patients had a standardized preoperative evaluation which included history, physical examination, assignment of incontinence status on a Stamey grading scale, postvoid residual (PVR) determination, Valsalva leak-point pressure, maximal urethral closure pressure, functional urethral length, Q-tip excursion angle, quantitative pad test, and completion of a quality of life questionnaire. On the day of injection they were randomly assigned to a periurethral or transurethral route of injection based on a computer-generated block randomization scheme. An ultrasound-determined PVR was obtained on all patients after injection. If self-catheterization was necessary, and the PVR was > 200 ml, urinary retention was diagnosed. Postoperative assessment included a patient interview, subjective assessment of improvement, PVR, voiding diary, and assignment of incontinence grade. At the screening visit there were no significant differences between the groups for any variables except type of stress incontinence. With short-term follow-up both transurethral and periurethral routes of injection seem to be equally efficacious. In the periurethral injection group there was a higher rate of postoperative retention; this group had a significantly higher volume of injectable agent used. There was no significant difference in risk of urinary tract infections between the two groups. We conclude that both periurethral and transurethral methods of bulking agent injection for stress urinary incontinence are equally efficacious, with minimal morbidity.