Macroplastique Injection Research Articles

Long-term Outcomes With Macroplastique in Women With Stress Urinary Incontinence Secondary to Intrinsic Sphincter Deficiency

To evaluate the long-term outcomes of polydimethylsiloxane (Macroplastique (MPQ)) in women with stress urinary incontinence (SUI) secondary to intrinsic sphincter deficiency (ISD) using validated questionnaires. Following IRB approval, charts of non-neurogenic women with SUI secondary to ISD who underwent MPQ injection were reviewed from a prospectively maintained database. ISD was defined as positive stress test with a well-supported urethra and low Valsalva leak point pressure when available. Excluded were women with follow-up <5years. Baseline data included validated questionnaire scores (UDI-6 question 3 (0-3), VAS Quality of Life, Incontinence Impact Questionnaire (IIQ-7)) and urodynamic study findings. Patients were followed with same questionnaires and three-dimensional ultrasound evaluating volume/configuration of MPQ. All three-dimensional ultrasound measurements were performed by the same imaging team blinded to clinical outcomes. Outcomes were evaluated in four groups based on prior SUI treatment. Success was defined as UDI-6 question 3 score of 0-1 and not requiring additional anti-incontinence therapy at the last visit after the last MPQ injection. From April 2011-December 2016, 106 patients (median age 67) met study criteria. Median follow-up time was 7.4years. Median MPQ injected was 5mL. Overall success was 43%, with 54% successful after one injection and 46% requiring ≥2 injections. Across all groups, patients had improvement in Quality of Life and IIQ-7 Question 7 (frustration). Among the failure group, 17% opted for a secondary autologous sling procedure. MPQ demonstrated long-term favorable outcomes in a subset of women with SUI secondary to ISD.

Endoscopic Treatment of Vesicoureteral Reflux with Macroplastique in Spinal Cord Injury Patients

Context/Objective: Vesicoureteric reflux (VUR) is a well-known complication of neurogenic lower urinary tract dysfunction. VUR results to progressive renal deterioration and eventually renal failure. Our aim was to assess the efficacy of Macroplastique bulking agent in managing VUR in spinal cord injury population and correlate the pre- and postintervention VUDS (Video-urodynamics) findings with the outcome. Design: Retrospective cohort study. Participants: Spinal cord injury patients with VUR, treated with Macroplastique, had pre- and postintervention VUDS and followed up for at least 12 months. Interventions: Macroplastique injection and video-urodynamics. Outcome Measures: The primary endpoint was the overall treatment rate of VUR at 3 months. The secondary outcomes were the overall treatment rate of VUR at 12 months, the success rate at 3 and 12 months, the need for additional treatments, and the comparison of VUDS parameters in treated versus failed cases. Results: Forty-eight patients and 62 refluxing ureteric units were studied. At 3-month follow-up, the overall treatment rate was 79.1%. The overall success rate (treated + improved) was 90.3%. There is a statistically significant difference in baseline cystometric capacity (P = 0.047), degree of reflux (P &lt; 0.01), and bladder compliance (P = 0.023) between the treated and failed cases. Conclusion: Macroplastique is effective in the management of VUR in spinal cord injury population. It is minimally invasive, quick, with low complication rates. Care should be taken to treat the parameters of the neurogenic bladder that contributes to secondary VUR development such as detrusor overactivity and poor bladder compliance.

Bladder neck and urethral erosions after Macroplastique injections

To evaluate the presentation, risk factors, diagnostic workup, management, and outcomes of Macroplastique (MPQ) erosions. 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. 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. 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.

Outcomes of Macroplastique injections for stress urinary incontinence after suburethral sling removal.

To evaluate outcomes following urethral Macroplastique (MPQ) injection in women with stress urinary incontinence (SUI) following suburethral sling removal (SSR) for synthetic sling complications. Following Institutional Review Board approval, charts of non-neurogenic women with SUI after SSR who underwent MPQ injection(s) and had at least 6 months minimum follow-up were reviewed from a prospectively maintained database. Demographic data, questionnaire (Urogenital Distress Inventory-6 [UDI-6] and Quality of Life) scores, and pad usage were recorded. Patients were followed with repeat questionnaires and three-dimensional ultrasound evaluating MPQ volume. Success following MPQ was defined as a composite score of a UDI-6 question 3 score of 0 to 1 at last visit and no additional anti-incontinence therapy. From 2011 to 2018, 70 women with mean age 62.7 years met study criteria. At a mean follow-up of 46.4 ± 1.5 months, the success rate after the first MPQ injection was 46%. Following a repeat MPQ injection when indicated, the overall success rate for the entire cohort was 69%. Despite the objective failure, the majority of patients reported subjective improvement (83%) and reduced pad usage (78%). On multivariate analysis: age, body mass index, previous hysterectomy, hormone replacement therapy, type of sling removed and baseline urodynamics (UDS) parameters were not predictors of MPQ failure. Higher parity was a predictor of MPQ failure (hazard ratio = 1.980; P = .032). MPQ injection is a durable and effective management option for SUI following SSR, although a second injection may be required to achieve the desired success.

28: How to recognize and de-bulk extruded urethral bulking agent

Current literature regarding extruded Macroplastique, a commonly used urethral bulking agent, is currently limited to case reports. To the best of our knowledge there is no literature or guidelines specifically walking through how to “de-bulk” or remove extruded Macroplastique. First, we aim to make the audience familiar with common adverse effects of Macroplastique injections with focus on the rare side effect of extrusion. Then we will introduce a removal technique we used to safely remove a rare case of extruded Macroplastique. A 49-year-old female presented with pelvic pain and irritative voiding symptoms approximately two years after undergoing transurethral Macroplastique injections for the treatment of stress urinary incontinence. A CT scan for surveillance of prior lung cancer demonstrated an incidental finding of a 1.4 cm periurethral mass. Follow up cystoscopy demonstrated a 5 mm region of extruded Macroplastique along the right urethrovesical junction. The patient desired surgical removal of the extruded bulking agent after extensive counseling. Cystoscopic biopsy forceps were used to first remove the exposed Macroplastique material and then apply gentle pressure adjacent to the erosion site to expose additional material, which was removed. The patient was discharged home on the day of surgery after passing an active voiding trial. Her irritative voiding symptoms improved post-operatively. Although rare, urethral extrusion is a known complication of transurethral Macroplastique injection. This video demonstrates a safe and effective removal method of the extruded material two years after placement.

Can Urethral Bulking Agents Salvage Failed Slings?

ObjectiveTo evaluate the efficacy of urethral bulking agents for stress urinary incontinence (SUI) in the setting of prior failed sling. MethodsThis is a retrospective review of patients who underwent urethral bulking agent injections for a primary complaint of SUI following prior failed sling surgery. The outcomes assessed were patient reported improvement, need for further interventions for incontinence and validated questionnaires. Values for questionnaires were obtained from the patient's preprocedure visit, at the first visit following their last injection and at their most recent visit within our system. ResultsOver the study period, 73 patients underwent urethral bulking agent injection following failed sling. Thirty-eight patients received Macroplastique injections and 35 had collagen injections. On average, patients underwent 2.6 injections. Seventy-one percent of patient reported at least partial symptom resolution at first postinjection follow-up. Validated questionnaire responses also improved at short-term follow-up (mean difference in American Urological Association Symptom Index-3.8, Michigan Incontinence Symptom Index-5.1, P <.01). Forty patients had long-term follow-up data available (mean 39.6 months postinjection). Statistically significant improvement persisted on the stress incontinence and quality of life domains of the validated questionnaires. ConclusionIn our cohort of patients with persistent or recurrent SUI following urethral sling procedure, 71% experienced short-term improvement or resolution of symptoms following urethral bulking agent injections, with SUI-specific improvement persisting at an average of 35 months in patients with available data.

PD32-09 MID-TERM MACROPLASTIQUE OUTCOME IN WOMEN WITH STRESS URINARY INCONTINENCE SECONDARY TO INTRINSIC SPHINCTER DEFICIENCY

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy II1 Apr 2018PD32-09 MID-TERM MACROPLASTIQUE OUTCOME IN WOMEN WITH STRESS URINARY INCONTINENCE SECONDARY TO INTRINSIC SPHINCTER DEFICIENCY Philippe Zimmern, Timothy Carroll, Alana Christie, Melissa Foreman, and Gaurav Khatri Philippe ZimmernPhilippe Zimmern More articles by this author , Timothy CarrollTimothy Carroll More articles by this author , Alana ChristieAlana Christie More articles by this author , Melissa ForemanMelissa Foreman More articles by this author , and Gaurav KhatriGaurav Khatri More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.1552AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To evaluate the long-term outcomes of Macroplastique (MPQ) in women with stress urinary incontinence (SUI) secondary to intrinsic sphincter deficiency (ISD) using validated questionnaires and three-dimensional ultrasound (3DUS). METHODS Following IRB approval, charts of non-neurogenic women with SUI secondary to ISD who underwent MPQ injection were reviewed from a prospectively maintained database. ISD was defined as low VLPP and absence of hypermobility on voiding cystourethrogram. Patients were divided into 3 groups: Naïve (Group I), Prior Anti-Incontinence Surgery including urethrolysis/sling removal, bladder neck suspension/sling, (Group II), and combined Prior Bulking Agent and Anti-Incontinence Surgery (Group III). Excluded were women with follow-up <6 months. Baseline data collected included questionnaire scores (UDI-6 question 3 (0-3) and VAS Quality of Life Questionnaire (0-10)) and urodynamic study values. Patients were followed with repeat questionnaires, patient symptomatic self-report, and 3DUS evaluating volume/configuration of MPQ. All 3DUS measurements were performed by the same senior sonographer blinded to clinical outcomes. Success was defined as a UDI-6 question 3 score of 0-1, patient self-report of improvement of at least 75%, usage of = 2 pads/day, or a VAS QoL score of =3, as well as not requiring additional anti-incontinence therapy. RESULTS Between 2011 and 2016, 106 of 149 women met study criteria. The average age and BMI of the whole population was 66 and 28, respectively. 67% of patients had 1 injection, while the remainder had 2 or more. The mean baseline UDI6 question 3 score was 2.6 and the mean baseline QoL score was 8. The success rate was 46% for Group I, 49% for Group II, and 62% for Group III at 30 months mean follow-up (p=.61). Over the same period, the mean overall UDI6 question 3 score and QoL score improved to 1.7 and 4.3, respectively. Of the success group (N=54), Group II contributed the largest proportion (56%) followed by Group I (24%). Of the failure group, 6 patients progressed to sling and 2 patients required an artificial urinary sphincter. 3DUS measurements confirmed only a 0.2cc decrease in MPQ volume each year after the final injection, which was independent of distribution (symmetric/circumferential or asymmetric). CONCLUSIONS At mid-term follow-up, MPQ was effective as both a primary and secondary treatment alternative for SUI secondary to ISD. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e648 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Philippe Zimmern More articles by this author Timothy Carroll More articles by this author Alana Christie More articles by this author Melissa Foreman More articles by this author Gaurav Khatri More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Can Distal Ureteral Diameter Predict Reflux Resolution After Endoscopic Injection?

To test the predictive value of distal ureteral diameter (UD) on reflux resolution after endoscopic injection in children with primary vesicoureteral reflux (VUR). This was a retrospective review of patients diagnosed with primary VUR between 2009 and 2012 who were managed by endoscopic injection. Seventy preoperative and postoperative voiding cystourethrograms were reviewed. The largest UD within the false pelvis was measured. The UD was divided by the L1-L3 vertebral body distance to get the UD ratio (UDR). One radiologist interpreted the findings of voiding cystourethrography in all patients. Clinical outcome was defined as reflux resolution. Seventy patients were enrolled in this series (17 boys and 53 girls). Mean age was 5.9 years (1.2-13 years). Grade III presented in 37 patients (53%), and 33 patients (47%) were of grade IV. Mean distal UD was 5.5mm (2.5-13mm). Mean UDR was 37.8% (18%-70%). Macroplastique injection was performed in all. Subureteric injection was performed in 60 patients (86%), whereas intraureteric injection was performed in 10 patients. No postoperative complications were detected. The effect of grade, UD, and UDR on success after endoscopic injection was tested. UD and UDR were significant predictors of reflux resolution on logistic regression analysis (P<.007 and .001, respectively). UDR provides an objective measurement of VUR and appears as a predictive tool of success after endoscopic injection.

Long-term efficacy of polydimethylsiloxane (Macroplastique) injection for Mitrofanoff leakage after continent urinary diversion surgery.

To assess the long-term efficacy of polydimethylsiloxane (Macroplastique) injection (MPI) in the treatment of Mitrofanoff leakage secondary to valve incompetence. Between 1995 and 2012, the records of 24 consecutive patients who underwent MPI for Mitrofanoff urinary leakage after continent cutaneous urinary diversion (CCUD) surgery were examined. All patients had a valve deemed of sufficient length (>2 cm) to attempt Macroplastique coaptation. Treatment outcomes were divided into three categories based on physician assessment: success (dry), partial success (>50% reduction in incontinence pads) and failure. Success rates were assessed according to the type of reservoir and conduit channel. The mean (range) follow-up was 30 (6-96) months. One patient had initial difficulty catheterising, and subsequently required major revision surgery. In all, 12 patients (50%) failed the treatment and subsequently underwent operative revision to the channel. Three patients (12.5%) achieved complete success; one patient had an appendix channel through native bladder and the remaining two had Monti channels through colon. Nine patients (37.5%) had partial success; success rates were higher with appendix channels (four of six) and colonic reservoirs (six of seven) when compared with Monti channels (eight of 18, 44%) and ileal reservoirs (zero of two). Five of the nine patients with partial success eventually required further surgical revision for deteriorating continence at a mean (range) of 41 (14-96) months, whilst the other four have maintained sufficient continence with MPI alone. Macroplastique bulking cured only 12.5% patients, but leakage was substantially improved in a further 37.5% allowing major surgery to be avoided or postponed in one half of the cohort. Appendix Mitrofanoffs do better than the Monti Mitrofanoff, with channels through colonic segments generally doing better than those through ileal bladders. MPI should be considered as a less invasive alternative to avoid or delay major reconstructive surgery.

Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery.

Incontinence after prostatectomy for benign or malignant disease is a well-known and often a feared outcome. Although small degrees of incidental incontinence may go virtually unnoticed, larger degrees of incontinence can have a major impact on a man's quality of life.Conceptually, post-prostatectomy incontinence may be caused by sphincter malfunction or bladder dysfunction, or both. Most men with post-prostatectomy incontinence (60% to 100%) have stress urinary incontinence, which is involuntary urinary leakage on effort or exertion, or on sneezing or coughing. This may be due to intrinsic sphincter deficiency and may be treated with surgery for optimal management of incontinence. Detrusor dysfunction is more common after surgery for benign prostatic disease. To determine the effects of surgical treatment for urinary incontinence related to presumed sphincter deficiency after prostate surgery for:- men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) - transurethral resection of prostate (TURP), photo vaporisation of the prostate, laser enucleation of the prostate or open prostatectomy - and- men with prostate cancer - radical prostatectomy (retropubic, perineal, laparoscopic, or robotic). We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, and handsearching of journals and conference proceedings (searched 31 March 2014); MEDLINE (January 1966 to April 2014); EMBASE (January 1988 to April 2014); and LILACS (January 1982 to April 2014). We handsearched the reference lists of relevant articles and conference proceedings. We contacted investigators to locate studies. Randomised or quasi-randomised trials that include surgical treatments of urinary incontinence after prostate surgery. Two authors independently screened the trials identified, appraised quality of papers, and extracted data. Only one study with 45 participants met the inclusion criteria. Men were divided in two sub-groups (minimal or total incontinence) and each group was randomised to artificial urethral sphincter (AUS) implantation or Macroplastique injection. Follow-up ranged from six to 120 months. In the trial as a whole, the men treated with AUS were more likely to be dry (18/20, 82%) than those who had the injectable treatment (11/23, 46%) (odds ratio (OR) 5.67, 95% confidence interval (CI) 1.28 to 25.10). However, this effect was only statistically significant for the men with more severe ('total') incontinence (OR 8.89, 95% CI 1.40 to 56.57) and the CIs were wide. There were more severe complications in the group undergoing AUS, and the costs were higher. AUS implantation was complicated in 5/22 (23%) men: the implant had to be removed from one man because of infection and in one man due to the erosion of the cuff, in one man the pump was changed due to mechanical failure, in one man there was migration to the intraperitoneal region, and one man experienced scrotal erosion. In the injectable group, 3/23 (13%) men had a complication: one man treated with Macroplastique injection had to be catheterised because of urinary retention and two men developed urinary tract infections. The evidence available at present was of very low quality because we identified only one small randomised clinical trial. Although the result was favourable for the implantation of AUS in the group with severe incontinence, this result should be considered with caution due to the small sample size and uncertain methodological quality of the study found.

Treatment Outcomes of Transurethral Macroplastique Injection for Postprostatectomy Incontinence

PurposeWe investigated the efficacy of transurethral injection of Macroplastique bulking agent (Uroplasty) for male stress urinary incontinence (SUI) after prostate surgery.Materials and MethodsThis retrospective review included men with SUI treated by transurethral injection for symptoms resulting from prostate surgery. Patients were evaluated at 1 month and 6 months after injection by determining the number of pads used per day and changes in incontinence symptoms. Treatment success was defined as use of 1 pad or fewer per day combined with subjective symptom improvement.ResultsThe study population comprised 30 men with a mean age of 66.1±5.3 years. Of the 30 patients, 24 (80.0%) underwent prostate cancer surgery and the remaining 6 (20.0%) underwent surgery for benign prostatic hyperplasia. The preinjection pad number was 2.9±1.9 pads per day. After injection treatment, the mean follow-up period was 9.3±12.7 months and the success rate was 43% (13/30) at 1 month and 32% (6/19) at 6 months. Injection was more likely to result in a successful outcome in patients with no preinjection radiation treatment history and higher abdominal leak point pressure (ALPP) than in those with a previous history of radiation treatment and lower ALPP, although this result was not statistically significant. Acute urinary retention occurred in 5 patients (17%).ConclusionsTransurethral Macroplastique injection treatment is a relatively non-invasive treatment method for male SUI with a success rate of 43% at 1 month and 32% at 6 months. Patients with a higher ALPP and no previous history of radiation therapy may experience better treatment outcomes.

A retrospective study on female urological surgeries over the 10 years following spinal cord lesion

To evaluate the efficacy and safety over a 10-year period of any urological operations required by female patients with spinal cord lesions (SCLs). Retrospective study of urological surgeries from our database performed on females with SCLs from 2001 to 2002. Surgery efficacy for neurogenic lower urinary tract dysfunctions (N-LUTDs) was evaluated by comparing 7-day voiding diaries pre- and post-surgeries, while individual investigations were done pre- and post-surgery to evaluate urological complications. Drawbacks were assessed. Thirty-eight out of 69 patients underwent one or more urological procedures. Twenty-one out of 42 patients with suprasacral lesions underwent interventions for N-LUTD. The main surgical treatment was endoscopic detrusor infiltration of botulinum-A (Botox 300 UI or Dysport 750 UI) performed 107 times on 15 subjects using aseptic intermittent catheterizations for neurogenic overactive bladder. Mean efficacy duration was 9.2 months. Six females with infrasacral lesions underwent at least one intervention for N-LUTD. Two females in each group underwent tension-free vaginal tape for stress urinary incontinence (SUI), reducing episodes per week of SUI by >90% after 5 years. The most serious urological complication was active vesico-ureteral reflux (VUR) in three patients, treated endoscopically with submucosal injection of Macroplastique. No VUR recurrence was detected during a 6-year follow-up. All bladder stones (five cases) and renal calculi (five cases) were treated with endoscopic transurethrally electrohydraulic lithotripsy and extracorporeal shock-wave lithotripsy, respectively. Overall, no serious drawbacks were observed. Mini-invasive surgeries were exclusively used to address urological issues in chronic SCL patients.

Three-dimensional endovaginal ultrasound examination following injection of Macroplastique for stress urinary incontinence: outcomes based on location and periurethral distribution of the bulking agent

Our aim was to use three-dimensional enodovaginal ultrasound (3D EVUS) to identify sonographic parameters that are associated with successful outcomes following injection of Macroplastique. Three hundred and sixty degree 3D EVUS was performed in 100 treatment-naïve patients following Macroplastique injection. The location, volumes, periurethral distribution, and distance of the hyperechoic densities from the urethrovesical junction were assessed. The patients were divided into two groups: group A (n = 72): patients who had good clinical outcome and group B (n = 28): patients who were not improved or worsened. The two groups were compared with respect to the ultrasound parameters measured. Group A had a greater proportion of women with Macroplastique located in the proximal urethra, while midurethral location was found to be significantly more frequent in group B (p = 0.036). The odds of a circumferential periurethral distribution in group A were 13.62 times the odds in group B (95% CI: 5.12-56.95). When the location of the injection and the type of periurethral distribution were considered together, it was found that when the site of injection was proximal, the odds of circumferential distribution in group A was significantly greater than those in group B (odds ratio [95% CI]: 22 [3.05-203.49]; p < 0.001). Proximally located Macroplastique and circumferential periurethral distribution of Macroplastique are individually associated with successful outcomes following the injection. The combination of circumferentially distributed and proximally located Macroplastique is associated with the best short-term clinical outcomes.

Severe Hydronephrosis and Dysuria-Hematuria Syndrome after 20 Years of Bladder Exstrophy Correction: A Case Report

The aim of this paper is to report a case of severe hydronephrosis and incontinence 20 years after bladder exstrophy repair, managed successfully by secondary ureteroneocystostomy and by transurethral submucosal injection of Macroplastique.

Clinical Efficacy and Safety in Children with Vesicoureteral Reflux of a Single Injection of Two Different Bulking Agents – Polydimethylsiloxane (Macroplastique) or Dextranomer/Hyaluronic Acid Copolymer (Deflux): A Short-Term Prospective Comparative Study

Purpose: To compare the clinical efficacy and safety in children with vesicoureteral reflux (VUR) of a single injection of two different bulking agents: polydimethylsiloxane (Macroplastique) or dextranomer/hyaluronic acid copolymer (Deflux). Methods: A total of 73 patients (106 renal units, 41 boys and 32 girls) aged 2–15 years (mean age, 34.5 months) were included. A single subureteral injection of either Macroplastique or Deflux was performed in 37 children (55 ureters) and 36 children (51 ureters), respectively. VUR was grade II in 34 ureterorenal units, grade III in 23, grade IV in 31, and grade V in 18 ureterorenal units. Results: Overall, the reflux was corrected in 84 of the renal units (86%) with one injection. The correction rates, according to the reflux grade, were 91, 91, 83, and 72% for grades II–V, respectively. At the 3-month follow-up visit, reflux was corrected in 48 (87%) of 55 refluxing ureters in the Macroplastique group and in 43 (84%) of 51 refluxing ureters in the Deflux group. Conclusions: A single subureteral injection of either Macroplastique or Deflux is an effective treatment modality for children with VUR. The procedure was well tolerated, safe, and associated with low morbidity.

Effect of the Macroplastique Implantation System for stress urinary incontinence in women with or without a history of an anti-incontinence operation

We evaluated the outcomes and the effect of the Macroplastique Implantation System on the quality of life in women with stress incontinence with or without a history of an anti-incontinence operation during 12 to 62 months follow-up. Thirty-five women with urodynamically proven stress incontinence with intrinsic sphincter deficiency were included in this study. Macroplastique injection was performed in all patients. Quality of life was evaluated prior to therapy, in early postoperative time (at the sixth weeks) and in late postoperative time (12 to 62 months follow-up) with the use of three different questionnaires: Incontinence Quality-of-Life Questionnaire (I-QOL), Incontinence Impact Questionnaire-7 (IIQ-7), and Urogenital Distress Inventory-6 (UDI-6). Questionnaires were also compared with those previous to the anti-incontinence operation and to the primary procedure groups. The median age of the women was 50.00 (interquartile range = 17.00) years. There were 24 primary procedures and 11 had undergone previous anti-incontinence surgery. Maximum follow-up time was 62 months, minimum follow-up time was 12 months, and the median follow-up time of the study was 58 (interquartile range = 44-60) months. When preoperative and postoperative median of the I-QOL, IIQ-7, and UDI-6 scores were compared, the differences between scores were found to be statistically significant. I-QOL, IIQ-7, and UDI-6 scores were related to the previous surgery. The overall I-QOL, IIQ-7, and UDI-6 summary scores showed high internal consistency. The Macroplastique injection system is an effective, safe, and acceptable option for stress urinary incontinence in women with or without a history of an anti-incontinence operation. Moreover, it can be performed under local anesthesia without cystoscopic guidance; moreover, side effects are rare.

Endoscopic Subureteral Injection for the Treatment of Vesicoureteral Reflux in Children: Polydimethylsiloxane (Macroplastique®) versus Dextranomer/Hyaluronic Acid Copolymer (Deflux®)

PurposeThe aim of this study was to compare cure rates and complications of polydimethylsiloxane (Macroplastique®) and dextranomer/hyaluronic acid copolymer (Deflux®) in the treatment of vesicoureteral reflux (VUR).Materials and MethodsFrom April 2001 to March 2008, 29 boys and 42 girls (total of 115 ureters) with a mean age of 6 years who had undergone endoscopic subureteral transurethral injection for VUR were enrolled. A single subureteral injection of Macroplastique was performed in 31 ureters in 23 children (group I; grade II: 4; grade III: 12; grade IV: 9; grade V: 6), and a single subureteral injection of Deflux was performed in 84 ureters in 48 children (group II; grade II: 24; grade III: 14; grade IV: 25; grade V: 21). Renal ultrasound was done 1 day after injection, and voiding cystourethrography (VCUG) was done at 3 months. Successful reflux correction was defined as absent or grade I reflux on follow-up VCUG.ResultsNo significant difference in success rates was observed between group I and group II [80.6% (25/31) vs. 78.6% (66/84), respectively, p>0.05]. The following postoperative complications developed: ureteral obstruction in 2 ureters of group I and 3 ureters of group II, asymptomatic urinary tract infection in 3 patients of group I and 2 patients of group II, and bladder calcification by erosion or mucosal necrosis in 2 patients of group I.ConclusionsDespite differences in material properties, both Macroplastique and Deflux were safe for the treatment of children with VUR. Because of the risk of bladder mucosal necrosis and substantial decreases in volume after implantation, long-term follow-up is required.

Mitchell's Detrusor Wrap-Around Bladder Neck (Dwbn), Ileocystoplasty, and the Extramural Serous-Lined Continent Outlet: An Optimal Triad

Purpose Providing continence for children with non compliant bladder and low detrusor leak point pressure secondary to neuropathic dysfunction or bladder exstrophy is a challenging task. A one stage reconstruction triad is presented. Material and Methods Between May 2005 to July 2008, 21 patients underwent DWBN, ileocystoplasty, and extramural serous lined tunnel as continent outlet in one stage. Patients included 15 boys and 6 girls with mean age of 7.6 years. Nine patients had previous complete repair of bladder exstrophy, 4 had staged repair and 8 had neuropathic bladder dysfunction. The ileum was fashioned in the shape of U in 4, S in 13, and W in 4. The appendix was used in 17 and Monti was used in 4. Neo umbilicus was constructed for the outlet in 13. In all patients the continent outlet was located in the umbilicus or a neo-umbilicus. Results Mean follow-up duration was 19 months (range 4-39). Early postoperative complications included prolonged ileus in 1 and urine leak in 1 and both were conservatively managed. Vesicoureteral reflux persisted in 13/21 (62%) patients. All patients were completely dry on CIC except 1. The leakge was through the urethra and was successfully managed by macroplastique injection at the bladder neck. No patient leaked through the continent outlet. Stomal stenosis was encountered in 2 patients with neo-umbilicus and both had stomal revision. No patient had bladder stones or perforation during follow-up. Conclusions Children with urinary incontinence secondary to the combination of a non-compliant bladder and sphincteric deficiency could be optimally managed with this triad. The DWBN provides optimal bladder neck reconstruction. The extramural serous-lined technique has the advantages of a leak-proof continent outlet, ease of catheterization through a straight channel, and the orthotopic position of the outlet in the umbilicus/neo-umbilicus in all patients.

Minimally invasive surgery in urogynecology

Minimally invasive surgery has been a term used to describe laparoscopic surgery and more recently the trocar-guided synthetic mid-urethral slings for stress incontinence and the trocar-guided synthetic mesh kits to treat prolapse. This term implies a lesser operation, more pain free and safer, which in many cases is not true. This description seems more to do with marketing the product and the surgeon than actually describing the benefits and risks of the procedure. When complications occur as they always will, they may be more unexpected by the patient and poorly tolerated. Therefore informed consent, giving the patient a clear understating of the procedure, possible risks and benefits, and likely outcome, is essential. Synthetic polypropylene slings (SPS) are not new and were used to treat women with stress incontinence by Morgan in Northern America and Moir in the UK in the 1960s. These slings were placed under the bladder neck through open abdominal and vaginal incisions. However, it was not until the mid-1990s with the introduction of the tension-free vaginal tape (TVT) that SPS gained widespread usage when placed through small incisions using trocar needles at the mid-urethral position. These retropubic slings have been found to have benefits of shorter hospitalization, less postoperative pain and a lower morbidity than the Burch colposuspension and fascial slings but equal effectiveness. Over the last 6 years, numerous variations of the TVT have been introduced, including the transobturator approach and the no-incision mini-slings (TVT Secur, Gynecare Ethicon Inc., Somerville, NJ) and Miniarc (American Medical Systems Inc., Minnetonka, MN). A major advantage of the transobturator and minislings is the avoidance of the retropubic space, decreasing complications such as bladder and bowel perforation, and major vascular injury. Bladder perforation in retropubic slings is a common complication with reported rates of 0.7% to 34.2% compared to 0% to 3.1% in the transobturator approach [1]; if recognized, sling replacement is performed without clinical sequel. Bowel and vascular injuries are more serious and have resulted in patient deaths. These complications have resulted in many surgeons changing from retropubic slings or preferring to learn the other approaches. Current sales of these stress incontinence devices according to industry sources are “obturator slings make up just over half of the total synthetic sling procedures performed in the US. Newer single incision slings represent between 15%–20%. The remaining 30% are retropubic slings. This is across all major/medium size brands.” However, is this change away from retropubic slings for perceived safety reasons premature and in the patient’s best long-term interests? Prospective randomized studies [1] comparing the retropubic and transobturator slings in woman with non-intrinsic sphincter deficiency (non-ISD) stress urinary incontinence (SUI) have shown no significant difference in effectiveness, although follow-up in these studies is of short duration (less than a year) and based on symptoms only. However, short-term subjective outcomes may not be indicative of more long-term results. In a study comparing pubovaginal sling to transurethral Macroplastique injection in ISD patients [2] the subjective symptomatic improvement was not significantly different at 6 months, but urodynamic SUI cure at 6 months, (81% vs. 9%) and 5 year symptomatic cure was significantly in favor of the pubovaginal fascial sling (69% vs. 21%). In women with ISD, SUI the retropubic TVT sling has been shown to be more Int Urogynecol J (2009) 20:485–486 DOI 10.1007/s00192-009-0854-5

Cross-Linked Polydimethylsiloxane Injection for Female Stress Urinary Incontinence: Results of a Multicenter, Randomized, Controlled, Single-Blind Study

In a pivotal trial we evaluated the effectiveness and safety of Macroplastique(R) as minimally invasive endoscopic treatment for female stress urinary incontinence primarily due to intrinsic sphincter deficiency. A total of 247 females with intrinsic sphincter deficiency were randomized 1:1 and treated with a transurethral injection of Macroplastique or Contigen. The latter group served as the control. Repeat treatment was allowed after the 3-month followup. Effectiveness was determined 12 months after the last treatment using Stamey grade, pad weight and Urinary Incontinence Quality of Life Scale scores. Safety assessment was recorded throughout the study. After 12 patients were excluded from study 122 patients received Macroplastique injection and 125 received Contigen injection. Mean patient age was 61 years and the average history of incontinence was 11.2 years. Of the patients 24% had undergone prior incontinence surgery. At 12 months after treatment 61.5% of patients who received Macroplastique and 48% of controls had improved 1 Stamey grade. In the Macroplastique group the dry/cure rate was 36.9% compared to 24.8% in the control group (p <0.05). In the Macroplastique and control groups the 1-hour pad weight decrease was 25.4 and 22.8 ml from baseline (p = 0.64), and the mean improvement in Urinary Incontinence Quality of Life Scale score was 28.7 and 26.4 (p = 0.49), respectively. Macroplastique injection was statistically more effective than Contigen for stress urinary incontinence primarily due to intrinsic sphincter deficiency with a 12.1% cure rate difference. Macroplastique can be administered on an outpatient basis. It should be considered a primary or secondary treatment option for stress urinary incontinence.