Detrusor nerve radiofrequency ablation (DENERA): Experimental study of safety and efficacy in an ovine model.

PURPOSE: The subtrigonal perivesical nerve plexus contains a large proportion of the bladder's innervation. A transurethral radiofrequency ablation approach has successfully denervated this region to alleviate overactive bladder symptoms, with some urothelial heat injury. We report a novel transvaginal RFA device (DENERA) and assess its feasibility and efficacy in denervating the perivesical nerve plexus of in vivo sheep. METHODS: In 14 adult female in vivo sheep, pulsed radiofrequency energy was applied transvaginally for three cycles of 4 min, maintaining the tissue temperature at 45°C, with 30 s of rest between each cycle. The control group (n = 4) was sacrificed without ablation, and various groups were sacrificed 1 week (n = 3), 4 weeks (n = 4), and 12 weeks (n = 3) after ablation. The bladder subtrigones were harvested then analyzed with H&E, S100, and TH immunostaining to quantify their neural density and neural vacuolization. RESULTS: The ablation procedure increased the neural vacuolization the most at 1 week and decreased the neural density the most at 4 weeks, with both variables displaying a significant change followed by a slight rebound towards baseline at 12 weeks. The H&E analysis showed that the needles penetrated deep into the subtrigonal detrusor muscle. The sheep recovered from the procedure with no complications or damage in the bladder wall or urothelium. CONCLUSIONS: This study shows that one DENERA treatment can cause subtrigonal denervation with some rebound afterwards and no complications. DENERA may become a promising OAB treatment option that can ablate the perivesical plexus without harming the urothelium.

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

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

An International Continence Society (ICS) report on the terminology for female pelvic floor fistulas.

INTRODUCTION: The terminology for female pelvic floor fistulas (PFF) needs to be defined and organized in a clinically based consensus Report. METHODS: This Report combines the input of members of the International Continence Society (ICS) assisted at intervals by external referees. Appropriate core clinical categories and a sub-classification were developed to give a coding to definitions. An extensive process of 19 rounds of internal and external review was involved to examine each definition, with decision-making by collective opinion (consensus). RESULTS: A terminology report for female PFF, encompassing 416 (188 NEW) separate definitions, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in different specialty groups involved in female pelvic floor dysfunction and PFF. Female-specific imaging (ultrasound, radiology, and magnetic resonance imaging) and conservative and surgical PFF managements as well as appropriate figures have been included to supplement and clarify the text. Interval (5-10 years) review is anticipated to keep the document updated and as widely acceptable as possible. CONCLUSION: A consensus-based terminology report for female PFF has been produced to aid clinical practice and research.

Workup and conservative management of ileal conduit-vaginal fistulas: review of literature.

Ileal conduit-vaginal fistulas are a rare but challenging complication of urinary diversion. Here we identify risk factors and summarize the workup and conservative management strategies for this complication. We present two cases of elderly women with remote history of cancer who presented with persistent urinary leakage from the vagina several years after ileal conduit creation. Fistulas may be identified using dye or imaging with a loopogram and looposcopy. Correction of obstruction such as stomal stenosis or urinary diversion should be pursued to relieve pressure off the conduit. Minimally invasive management such as fulguration can result temporary relief; however, the recurrence rate is high.

Autologous rectus fascia sling for treatment of stress urinary incontinence in women: A review of the literature.

AIMS: Stress urinary incontinence (SUI) is common in the adult females. Surgical treatment options include synthetic mid-urethral sling (MUS), autologous sling, bulking agents, and Burch colposuspension. The autologous pubovaginal sling (PVS) has re-emerged in response to complications of synthetic MUSs and FDA communications regarding the use of vaginal mesh. This resulted in patients' fear related to vaginal mesh and drop in number of patients seeking surgical treatment of SUI. PVS has re-emerged as an option for treatment of primary SUI. The aim of this review is to familiarize, disseminate information, and share tips for the practicing female pelvic surgeons related to the practice of the autologous fascia sling. METHODS: We reviewed the literature related to the autologous sling. We used the following data bases and search engines: GoPubMed (Transinsight), Cochrane reviews (Wiley Interscience), google scholar (google), and Scopus (Elsevier). Because it is the most commonly investigated and utilized, we focused on the autologous rectus fascia sling. We also focused on the retropubic sling approach because the literature on transobturator rectus fascia sling is sparse. RESULTS: Out of 307 articles related to the subject found, 22 articles were included and the rest were excluded. CONCLUSION: ARFS is a valid primary method of treatment for female SUI. Also, it is used in particular indications such as patients with intrinsic sphincter deficiency (ISD), prior pelvic irradiation, failed and/or complicated synthetic MUS, and violated urethral lumen.

Spinal cord stimulation ameliorates detrusor over-activity and visceromotor pain responses in rats with cystitis.

AIM: Interstitial cystitis/painful bladder syndrome/(IC/PBS) results in recurring pain in the bladder and surrounding pelvic region caused by abnormal excitability of micturition reflexes. Spinal cord stimulation (SCS) is currently clinically used for the attenuation of neuropathic and visceral pain. The present study examined whether SCS at upper lumbar segments modulates detrusor overactivity and visceral hyperalgesia associated with cystitis in a rat model of cyclophosphamide (CYP)-induced cystitis. METHODS: Cystitis was induced by intraperitoneal injection of CYP (200 mg/kg) in six adult female Sprague Dawley rats 48 h prior to urodynamic recordings. Another six rats served as-controls with saline injection. Cystometry and the external urethral sphincter (EUS) electromyography during bladder infusion were evaluated under urethane anesthesia. The visceromotor reflexes (VMR) obtained from the external abdominal oblique muscle were quantified during bladder infusion and isotonic bladder distension (IBD), respectively. After baseline recordings were taken, SCS was applied on the dorsal surface of L3 for 25 min. Urodynamic recordings and VMR during bladder infusion and IBD were repeated 2 h after SCS. RESULTS: CYP resulted in detrusor overactivity, stronger EUS tonic contractions, and increased VMR. SCS significantly reduced non-voiding contractions, prolonged EUS relaxation, and delayed VMR appearance during bladder infusion as well as significantly decreased VMR during IBD in cystitis rats. CONCLUSION: SCS improved bladder function and EUS relaxation during bladder infusion and significantly attenuated visceral nociceptive-related VMR during IBD in cystitis rats. SCS may have therapeutic potential for patients with hyperalgesia and IC/PBS.

Are Electronic and Paper Questionnaires Equivalent to Assess Patients with Overactive Bladder?

PURPOSE: Overactive bladder syndrome is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence in the absence of urinary tract infection or another obvious pathological condition. Electronic questionnaires have been used in a few specialties with the hope of improving treatment outcomes and patient satisfaction. However, they have not been widely used in the urological field. When treating overactive bladder, the main outcome is to improve patient quality of life. The primary objective of this study was to evaluate whether electronic questionnaires would be equally accepted as or preferred to paper questionnaires. The secondary objective was to look at the preference in relation to patient age, education and iPad® tablet familiarity. MATERIALS AND METHODS: We prospectively evaluated the iList® electronic questionnaire application using a friendly iPad tablet in patients with overactive bladder who presented to the urology clinic at our institution. Each of the 80 patients who were recruited randomly completed the validated OABSS (Overactive Bladder Symptom Score) and the PPBC (Patient Perception of Bladder Condition) questionnaires in paper and electronic format on the tablet. Variables potentially associated with the outcomes of interest included demographic data, questionnaire method preference, patient response rate and iPad familiarity. We used the 2-sided Z-test to determine whether the proportion of patients who considered the tablet to be the same, better or much better than paper was significantly greater than 50%. The 2-sided chi-square test was applied to assess whether the intervention effect significantly differed among the demographic subgroups. RESULTS: A total of 80 patients 21 to 87 years old were enrolled in the study from November 2015 to August 2016. Of the patients 53% were female and 49% were 65 years or younger. The incidence of those who considered the tablet to be the same or better than paper was 82.5% (95% CI 74.2-90.8, p <0.001). The incidence of patients who considered the tablet to be the same or better than paper ranged from 76% to 97% regardless of age, gender and education subgroup as well as in those with any familiarity with the tablet (each p <0.001). Of the 20 patients who were not familiar with the tablet 45% preferred the electronic questionnaire (p = 0.654). CONCLUSIONS: We found that the proportion of patients who considered electronic questionnaires to be equivalent to or better than paper versions was higher than those who preferred paper questionnaires regardless of age, gender or education level.

Surgical technique for removal of tined lead for InterStim.

INTRODUCTION: We aimed to introduce our technique describing the removal of a chronic implanted tined-lead in patients with a sacral neuromodulator implant. MATERIALS AND METHODS: We performed a retrospective review of patients who had chronic sacral neuromodulator (InterStim) implanted by a single surgeon from 2001 through 2015. This simple surgical technique was developed and successfully performed to remove the leads. Primary reasons for removal were elective due to poor symptoms control and failure to maintain response or lead migration. Patient demographics, indication for implantation, as well as installation and removal complications were recorded and analyzed. RESULTS: Twenty-five patients were included [mean age: 60.4 years (32-86), 17 females]. Primary indications for sacral nerve stimulation were overactive bladder in 16 (64%), mixed incontinence in 6 (24%), urinary retention in 2 (8%), and interstitial cystitis 3 (12%). Mean implant duration was 24.2 (0.5-90) months. The existing tined lead was removed and replaced in 11 (44%) patients while the remaining 14 (56%) underwent complete removal of the unit without subsequent replacement. Successful lead removal without complications was achieved in 24 (96%) patients. CONCLUSIONS: This minimally invasive technique is a simple, safe, and effective method of removing chronic implanted tined leads en bloc.

Redefining the Autonomic Nerve Distribution of the Bladder Using 3-Dimensional Image Reconstruction.

PURPOSE: We sought to create a 3-dimensional reconstruction of the autonomic nervous tissue innervating the bladder using male and female cadaver histopathology. MATERIALS AND METHODS: We obtained bladder tissue from a male and a female cadaver. Axial cross sections of the bladder were generated at 3 to 5 mm intervals and stained with S100 protein. We recorded the distance between autonomic nerves and bladder mucosa. We manually demarcated nerve tracings using ImageScope software (Aperio, Vista, California), which we imported into Blender™ graphics software to generate 3-dimensional reconstructions of autonomic nerve anatomy. RESULTS: Mean nerve density ranged from 0.099 to 0.602 and 0.012 to 0.383 nerves per mm2 in female and male slides, respectively. The highest concentrations of autonomic innervation were located in the posterior aspect of the bladder neck in the female specimen and in the posterior region of the prostatic urethra in the male specimen. Nerve density at all levels of the proximal urethra and bladder neck was significantly higher in posterior vs anterior regions in female specimens (0.957 vs 0.169 nerves per mm2, p<0.001) and male specimens (0.509 vs 0.206 nerves per mm2, p=0.04). CONCLUSIONS: Novel 3-dimensional reconstruction of the bladder is feasible and may help redefine our understanding of human bladder innervation. Autonomic innervation of the bladder is highly focused in the posterior aspect of the proximal urethra and bladder neck in male and female bladders.

Female pelvic medicine and reconstructive surgery practice patterns: IUGA member survey.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to describe the current practice patterns of the International Urogynecological Association (IUGA) members regarding the diagnosis, evaluation, and surgical management of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). METHODS: A 30-item internet-based survey was sent to IUGA members. Response to the survey was voluntary, and subjects answered questions regarding demographics, the evaluation of POP and SUI, including urodynamics (UDS) testing, preferred management of POP and SUI, and the application of mesh in reconstructive surgery. RESULTS: Three hundred and thirty-four IUGA members responded to the survey; most of the responses were from Europe (40 %) and North America (23 %). After the FDA safety communication regarding serious complications of using transvaginal mesh, 45 % of responders reported decreased use of mesh, while 31 % reported that it had no effect or that they did not use mesh for transvaginal prolapse (23.6 %). Regarding the evaluation and treatment of SUI, 51 % of responders would perform urodynamics (UDS) before surgical correction of uncomplicated SUI and 78.5 % of responders would perform UDS if no urine leakage was demonstrated on examination. The preferred method of treatment for SUI is midurethral sling (MUS), regardless of prior treatments (65.1 %), concomitant surgeries (74.5 %), or examination findings (50.8-92.6 %). Regarding POP repair, the preferred approach for apical (61 %) and posterior (99.4 %) prolapse repair is vaginal. CONCLUSIONS: Most respondents use a vaginal approach for POP surgery. The FDA safety communication regarding serious complications related to the use of transvaginal mesh for prolapse surgery led to a global decrease in the employment of mesh for POP. Synthetic midurethral slings are predominant in the current treatment of SUI. Despite new recommendations, many responders still perform UDS for uncomplicated SUI.

Arabic validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR).

INTRODUCTION AND HYPOTHESIS: Our aim was to translate then assess the reliability of the culturally adapted Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire, International Urogynecological Association (IUGA)-Revised (PISQ-IR) to assess sexual health among Arabic-speaking women with pelvic floor disorders. METHODS: PISQ-IR was modified to consider cultural characteristics of the Middle East. The final reliability study included 172 women with urinary incontinence (UI) and/or pelvic organ prolapse (POP). Participants completed the questionnaire twice: at enrollment and 2 weeks later. RESULTS: Among sexually active women, good internal consistency was observed for five of the six scales in the adapted instrument: Global Quality (Cronbach's coefficient α = 0.86), Condition Impact (α = 0.87), Desire (α = 0.82), Condition Specific (α = 0.74), and Partner Related (α = 0.75). Internal consistency was acceptable for the Arousal Orgasm subscale (α = 0.66). However, among not sexually active women, internal consistency was poor (α <0.6) for all four scales. Lin's concordance correlation coefficient measuring agreement between test and retest measurements [Lin's concordance correlation coefficient (CCC); a value of 1 represents perfect agreement] ranged from 0.81 to 0.87 for the not sexually active scales, except for condition impact (CCC = 0.63.) For sexually active women, CCC was typically stronger, ranging from 0.85 to 0.96. CONCLUSIONS: PISQ-IR questionnaire is easy to administer and reliable for assessing sexual function in sexually active Arabic women with POP and UI, but internal consistency is poor for Arabic women not sexually active.

A systematic review and meta-analysis of Macroplastique for treating female stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Macroplastique® (polydimethylsiloxane injection) is a minimally invasive urethral bulking agent with global clinical literature describing its use over 20 years. This study critically assessed the safety and effectiveness outcomes for adult women treated with Macroplastique for stress urinary incontinence (SUI) through a systematic review and meta-analysis. METHODS: A systematic review of the scientific literature from 1990 to 2010 was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement to quantitatively summarize the safety and effectiveness of Macroplastique for female SUI. A total of 958 patients from 23 cohorts were eligible for inclusion and were analyzed. Random-effects models were used to estimate the improvement and cure rates following treatment at three time periods: short-term (<6 months), mid-term (6-18 months), and long-term (>18 months). Expanded models assessed the effect of reinjection rate on successful treatment outcomes. Adverse event rates were aggregated and reported. RESULTS: Improvement rates were 75 % [95 % confidence interval (CI), 69-81] in the short-term, 73 % (95 % CI, 62-83) in the mid-term, and 64 % (95 % CI, 57-71) long-term. Cure/dry rates were 43 % (95 % CI, 33-54), 37 % (95 % CI, 28-46), and 36 % (95 % CI, 27-46) over the same respective follow-up periods. Higher study reinjection rates were associated with improved long-term SUI outcomes. No serious adverse events were reported. CONCLUSIONS: This quantitative review supports Macroplastique as an effective, durable, and safe treatment option for female SUI. Meta-analytic evidence suggests that long-term therapeutic benefit is frequently maintained, with some patients requiring reinjection.

The outcome of transobturator anterior vaginal wall prolapse repair using porcine dermis graft: intermediate term follow-up.

INTRODUCTION AND HYPOTHESIS: We evaluated the anatomical success and complications of Perigee® with porcine dermis Graft in the repair of anterior vaginal wall prolapse (AVWP) MATERIALS AND METHODS: After Institutional Review Board (IRB) approval, the charts of all patients who underwent AVWP repair using the Perigee/InteXen® kit from July 2005 to July 2009 were reviewed. Patients who had less than 6-month follow-up were excluded. Preoperative data including patient age, previous AVWP repairs, hysterectomy status, preoperative dyspareunia and pertinent physical findings were collected and recorded. Postoperative success was defined as anatomical stage 0 or I using the Pelvic Organ Prolapse Quantification (POP-Q) scoring system. Graft related complications were also recorded. RESULTS: Out of 89 patients, 69 completed at least 6-month follow-up. Median follow-up was 13 (6-48) months. Seventeen patients (25%) had previous AVWP repair and 32 (46%) had previous hysterectomy. Preoperatively, AVWP stage II was found in 9 (13%), stage III in 27 (39%) and stage IV in 33 (48%) patients. Anatomic success was found in 48 (69%) patients, with 23 (33%) having stage 0 and 25 (36%) stage I AVWP. Intraoperative complications included incidental cystotomy in one patient and bladder perforation in one. Postoperative complications included vaginal exposure and dyspareunia in one case, wound dehiscence in one and tenderness over the graft arm with dyspareunia in one. CONCLUSIONS: The use of porcine dermis in AVWP repair is safe with minimal graft related complications; however, anatomical success is lower than that reported with the use of synthetic grafts.

Foreign body granuloma development after calcium hydroxylapatite injection for stress urinary incontinence: A literature review and case report.

Objectives: To present a case of foreign body granuloma (FBG) development after injection of calcium hydroxylapatite as a urethral bulking agent and to review all documented cases of this phenomenon in the literature. Methods: We analyzed a new case of calcium hydroxylapatite-induced FBG. We also conducted a literature review of the PubMed, Embase, CINAHL, and Web of Science databases through March 2022. Reports were included if they contained stress urinary incontinence patients that developed an FBG after calcium hydroxylapatite injection. The cases were reviewed for presenting symptoms, patient demographics, granuloma details, and surgical treatment. Results: We screened 250 articles and included six articles between 2006 and 2015 in addition to the present case. The median age of the patients was 65.5 years (range 45-93), and all patients were female. The most common presenting symptoms and the proportion of patients affected were difficulty voiding (4/8), recurrent urinary incontinence (3/8), and dyspareunia (2/8). The median time between the first CaHA injection and discovery of the FBG was 5 months (range 1-50). The median longest dimension of the FBGs was 1.85 cm (range 1.0-3.0). The 8 masses observed were evenly distributed throughout the urethra, with 3 in the bladder neck, 2 in the midurethra, and 3 in the distal urethra. Surgical excision was the predominant management choice, with some variation in technique. Conclusions: Severe, persistent lower urinary tract symptoms after calcium hydroxylapatite injection may indicate an FBG, which has been successfully managed with surgical excision.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Standardized terminology has yet to be developed for reporting the outcomes for surgery for pelvic organ prolapse (POP). METHODS: This report combines the input of the Terminology and Standardization Committees of the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and a joint Working Group on this topic, as well as expert external referees. The aim was to present a standardized terminology for the definitions of surgery and propose a structure for reporting the outcomes of surgical procedures for POP. An extensive drafting and review process was undertaken, as well as open review on both IUGA and ICS websites. RESULTS: A terminology report was developed outlining the recommended structure for reporting outcomes of surgical trials involving POP. This document does not define success and failure. The report includes patient-reported subjective and objective outcomes to enable researchers to report on their results and compare them with other studies. CONCLUSIONS: A consensus-based method for standardizing terminology for reporting outcome measures of POP surgery was developed to aid clinicians working in this area of research. Neurourol. Urodynam. 31:415-421, 2012. © 2012 Wiley Periodicals, Inc.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Standardized terminology has yet to be developed for reporting the outcomes for surgery for pelvic organ prolapse (POP). METHODS: This report combines the input of the Terminology and Standardization Committees of the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and a joint Working Group on this topic, as well as expert external referees. The aim was to present a standardized terminology for the definitions of surgery and propose a structure for reporting the outcomes of surgical procedures for POP. An extensive drafting and review process was undertaken, as well as open review on both IUGA and ICS websites. RESULTS: A terminology report was developed outlining the recommended structure for reporting outcomes of surgical trials involving POP. This document does not define success and failure. The report includes patient-reported, subjective and objective outcomes to enable researchers to report on their results and compare them with other studies. CONCLUSIONS: A consensus-based method for standardizing terminology for reporting outcome measures of POP surgery was developed to aid clinicians working in this area of research.

Center-by-center results of a multicenter prospective trial to determine the inter-observer correlation of the simplified POP-Q in describing pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: This study was conducted to determine the differences in the inter-observer agreement of the simplified Pelvic Organ Prolapse Quantification (POP-Q) system from center to center in a large international multicenter study. METHODS: This is a secondary analysis of the results of a large prospective single blind multicenter trial studying the inter-observer agreement of a simplified POP-Q exam. Twelve centers from four continents with a total of 511 subjects were included in this study. The number of subjects recruited per center ranged from 20 to 81. Each patient was independently examined by two investigators, with examination order randomly assigned and investigators blinded to each other's result. The weighted kappa statistic was used to evaluate the inter-observer agreement. RESULTS: Good and significant associations were observed on the anterior, posterior, and apical segments. Six out of 11 sites did not provide adequate number of subjects with prior hysterectomy for weighted kappa statistics or achieve significance regarding vaginal cuff measurement. CONCLUSIONS: The simplified POP-Q demonstrated good inter-examiner agreement across multiple centers.

Bladder mass "collagenoma".

Large bladder masses are typically found to be malignant in nature. We present a case of a large bladder neck mass as a result of previous imprecise collagen injection for urethral bulking. The patient was successfully treated as an outpatient with transurethral excision of the collagen mass combined with post-operative anticholinergic therapy.