Pentosan polysulfate in patients with bladder pain syndrome/interstitial cystitis with Hunner's lesions or glomerulations: systematic review and meta-analysis.

Background: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a persistent pain perceived in the urinary bladder region, accompanied by at least one symptom, such as pain worsening with bladder filling and daytime or nighttime urinary frequency without any proven infection or obvious pathology. The aim of this study is to evaluate the efficacy and safety of pentosan polysulfate (PPS) in patients with BPS/IC. Methods: Systematic search was performed by PRISMA checklist. Electronic databases, including PubMed and Cochrane library, were checked until 2021 using keywords: 'pentosan polysulfate', 'pain syndrome', 'interstitial cystitis', and bibliography of relevant papers was checked. Inclusion criteria: Patients with confirmed diagnosis of BPS/IC and cystoscopy criteria - Hunner's lesions. Exclusion criteria included hypersensitivity, pregnancy, lactation, and oral therapy for BPS/IC in the period of 1 month before the study and abstracts or unpublished papers. Results: In total, 13 clinical trials were included in systematic review and 7 were included in meta-analysis. Studies evaluated the effectiveness and safety of oral PPS versus placebo or other treatment options. In the first meta-analysis, three studies compared oral PPS with placebo: [relative risk (RR) = 2.07, 95% confidence interval (CI): 1.37-3.13, p = 0.0006]. The second meta-analysis of two studies compared oral PPS with another treatment options (intravesical liposome and CyA): (RR = 0.44, 95% CI: 0.10-1.93, p = 0.28). The third meta-analysis of two studies included intravesical regimen of PPS compared with intravesical placebo: (RR = 1.09, 95% CI: 0.54-2.22, p = 0.80). The majority of studies do not report any particular serious side effects. Conclusion: PPS treatment has a statistically significant effect over placebo on the subjective improvement of patients with BPS/IC. There was no difference between PPS and other treatment options. Intravesical regimen of PPS had no significant impact on response rates. None of included studies reported severe side effects after intervention.

Anatomical and functional outcomes of non-obstetric urogenital fistula repair.

INTRODUCTION AND HYPOTHESIS: Studies on non-obstetric urogenital fistulas (NOUGFs) provide limited information on predictive outcome factors. This study was aimed at specifying and analyzing the risk factors for long-term anatomical and functional results. METHODS: A cross-sectional study of surgical repair for non-obstetric urogenital fistula was performed. From 2012 to 2020, a total of 479 patients with urogenital fistulas were treated in two tertiary centers. Patients with isolated ureteral fistulas and rectal injuries were excluded. For evaluation of the long-term results, patients with vesicovaginal and urethrovaginal fistulas with at least 12 months of follow-up were identified and contacted by phone and/or examined in the clinic. The anatomical outcome was assessed by resolution of symptoms and/or clinical examination. The Urinary Distress Inventory (UDI-6) was used for the functional outcomes. RESULTS: Overall, 425 patients were studied (mean age was 49.8; BMI 27.5; mean fistula size 1.4 cm, mean follow-up was 12 months). Vesicovaginal fistula affected 73% of patients. Hysterectomy without radiation was the most common etiology (66.3%), followed by hysterectomy with subsequent radiation (16%) and pelvic radiotherapy (12.2%). The transvaginal approach was used in 54.4%, abdominal in 12.4%, transvesical in 22.4%, and a combined approach in 10.8%. The successful closure rate was 92.9% for primary cases, 71.6% for secondary cases, and 66.7% for radiation fistulas. A high risk for relapse was found for NOUGFs with ureteral involvement (RR 2.5; 95% CI 1.3-4.5; p = 0.003), radiation fistulas (RR 2.1; 95% CI 1.3-3.5, p = 0.003); and combined radiation and hysterectomy cases (RR 2.9; 95% CI 1.8-4.6; p = 0.0001). In multifactorial analysis, fistula size >3.0 cm, pelvic radiation, and previous vaginal surgeries were associated with a higher risk for failure or lower urinary symptoms. CONCLUSIONS: Factors for successful NOUGF closure are fistula size less than 3.0 cm, absence of pelvic radiation, and previous vaginal surgeries.

Suburethral Synthetic Adjustment-controlled Tape Compared with Conventional Treatment for Female Stress Urinary Incontinence: A Randomized Controlled Trial.

BACKGROUND: Urinary incontinence (UI) is a urological problem in women. Currently, suburethral slings are the standard of surgical treatment for stress UI in the female population. OBJECTIVE: To prove the feasibility of an operating technique using suburethral adjustment-controlled tape (SACT) placement. DESIGN, SETTING, AND PARTICIPANTS: A single-center comparative randomized controlled trial included patients randomized according to the CONSORT checklist from April to October 2018 and from November 2018 to April 2019. The inclusion criteria were women from 21 to 81 yr, stress and mixed UI forms, and positive cough test. The exclusion criteria were pregnancy, lactation, neurogenic bladder dysfunction, recurrent forms of UI, radiation therapy and pelvic surgery in anamnesis, genital prolapse (Pelvic Organ Prolapse Quantification system >2), urinary infection, and obstructive urination. INTERVENTION: The first group (50 patients) was using synthetic SACT and the second group (75 patients) a transobturator tape (TOT) midurethral sling (MUS). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Subjective efficacy of 96% was established in group 1 and 86% in group 2, with a median follow-up of 12 mo. According to gynecological examination results, the objective surgical treatment efficiency was 96% in group 1 and 90.7% in group 2. This statistically significant indicator was evaluated in each group. However, when comparing both groups, no statistical difference was revealed. According to urodynamic studies, 1 mo after surgery in group 1, terminal and phase detrusor overactivity signs were 18% (n = 9) and 12% (n = 6), respectively. In group 2, these were 14.7% (n = 11) and 12% (n = 9), respectively. RESULTS AND LIMITATIONS: The block approach was used to randomize patients into groups. A total of 125 patients (50 in the main group and 75 in the control group) were analyzed. CONCLUSIONS: Our results prove the efficacy and safety of SACT in treating UI in women. The subjective and objective effectiveness results of treating patients in the study group show the possibility of using SACT in the same row with TOT MUS. PATIENT SUMMARY: Our purpose was to standardize the surgery stage for urinary incontinence, and evaluate the effectiveness and safety of suburethral adjustment-controlled tape placement. We analyzed women with urinary incontinence and used two different surgical methods. Our results prove the efficacy and safety of suburethral adjustment-controlled tape in treating urinary incontinence in women.

Effectiveness and safety of bulking agents versus surgical methods in women with stress urinary incontinence: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the efficacy and safety of bulking agents compared with surgical methods for female stress urinary incontinence. METHODS: Inclusion and exclusion criteria: women with stress urinary incontinence. Bulking agents versus any surgical treatment as a comparison. Patients with other types of incontinence and treatment were excluded. Electronic databases (PubMed, MEDLINE, and the Cochrane Library) were searched from 2000 until 2021 to identify articles evaluating the effectiveness and safety of urethral bulking agents versus surgical methods. Risk-of-bias assessment tools recommended by the Cochrane Society were used to evaluate the risk of bias in the studies included. RESULTS: Six studies were included in the quantitative synthesis for a total of 710 patients. Our systematic review and meta-analysis showed that bulking agents are less effective than surgical procedures according to subjective improvement after treatment (RR = 0.70, 95% CI: 0.53 to 0.92, p = 0.01). There was no statistically significant difference between these two methods with regard to complications after the intervention (RR = 1.30, 95% CI: 0.30 to 5.66, p = 0.73). CONCLUSION: The main limitation of this systematic review and meta-analysis was the absence of a common objective outcome measure to evaluate effectiveness. However, it shows that bulking agents are less effective than surgical procedures in subjective improvement. Safety analysis showed no significant difference between these methods. Hence, we believe that the first and final surgery is considered to be the best.

Robotic sacrocolpopexy in pelvic organ prolapse: a review of current literature.

PURPOSE OF REVIEW: Recently, robotic sacrocolpopexy has become the gold standard for treating genital prolapse. Despite this, there is still much interest in this procedure, and many questions remain unanswered. This review focuses on the most critical articles on this issue that have been published in the last 2 years. RECENT FINDINGS: A summary of 23 articles is provided. There were no differences in total postoperative complications, postoperative stress incontinence, mesh erosion, and the success of the two surgical techniques in long-term investigations. Obesity modestly increases robotic approach difficulty and does not raise the mesh erosion rate or prolapse recurrence rate. Ultra-light and preprepared meshes with alternative fixation techniques can be applied with these procedures. Another emerging trend is alternative robotic approaches and the use of single-port surgery. SUMMARY: For women with pelvic organ prolapse, especially the elderly and obese, robotic sacrocolpopexy is well tolerated and effective. Despite highly restricted and heterogeneous data, recent investigations have included single incision methods and new mesh/fixation materials. Randomized trials with large sample size and excellent quality are necessary before the practical implementation of new techniques.

Safety and efficacy of pentosan polysulfate in patients with bladder pain syndrome/interstitial cystitis: a multicenter, double-blind, placebo-controlled, randomized study.

INTRODUCTION: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a condition that is characterized by urgency, frequency and/or pelvic pain. The disease occurs mainly in women. BPS/IC can be severe enough to have a significant impact on patients' quality of life, but it can also be associated with moderate symptoms that are equally debilitating.The aim of this article was to evaluate the possibility of the use of pentosan polysulfate sodium in patients in the complex treatment of BPS/IC. MATERIAL AND METHODS: A multicenter, double-blind, placebo-controlled, randomized study was conducted in parallel groups in 7 Russian medical centers. RESULTS: Efficacy and safety have been established as the main criteria. A total of 93 patients were screened. Statistical analysis was performed. It has been shown that pentosan therapy is more effective than in the placebo. Average change in the number of points on the scale O'Leary-Santa Interstitial Cystitis Symptom Index compared to baseline data in the pentosan group 4.93 ±3, 03, in the placebo group 1.66 ±3.19 (p = 0.014), and the adverse events and safety of pentosan are comparable to the placebo group. CONCLUSIONS: Oral glycosaminoglycan (pentosan polusulfate sodium) is an effective and safe drug and should be included in the complex treatment of patients with bladder pain syndrome/interstitial cystitis.

Management of Female and Functional Urology Patients During the COVID Pandemic.

CONTEXT: Coronavirus disease 19 (COVID-19) has changed standard urology practice around the world. The situation is affecting not only uro-oncological patients but also patients with benign and disabling conditions who are suffering delays in medical attention that impact their quality of life. OBJECTIVE: To propose, based on expert advice and current evidence where available, a strategy to reorganize female and functional urological (FFU) activity (diagnosis and treatment). EVIDENCE ACQUISITION: The present document is based on a narrative review of the limited data available in the urological literature on SARS-Cov-2 and the experience of FFU experts from several countries around the world. EVIDENCE SYNTHESIS: In all the treatment schemes proposed in the literature on the COVID-19 pandemic, FFU surgery is not adequately covered and usually grouped into the category that is not urgent or can be delayed, but in a sustained pandemic scenario there are cases that cannot be delayed that should be considered for surgery as a priority. The aim of this document is to provide a detailed management plan for noninvasive and invasive FFU consultations, investigations, and operations. A classification of FFU surgical activity by indication and urgency is proposed, as well as recommendations adopted from the literature for good surgical practice and by surgical approach in FFU in the COVID-19 era. CONCLUSIONS: Functional, benign, and pelvic floor conditions have often been considered suitable for delay in challenging times. The long-term implications of this reduction in functional urology clinical activity are currently unknown. This document will help functional urology departments to reorganize their activity to best serve their patients. PATIENT SUMMARY: Many patients will suffer delays in urology treatment because of COVID-19, with consequent impairment of their physical and psychological health and deterioration of their quality of life. Efforts should be made to minimize the burden for this patient group, without endangering patients and health care workers.

Extended robotic salvage lymphadenectomy in patients with 'node-only' prostate cancer recurrence: initial experience.

INTRODUCTION: Biochemical relapse (BR) after a primary radical prostatectomy may occur in up to 40 percent of cases. Salvage lymphadenectomy has been proposed in patients with 'node-only' driven BR, following a definitive treatment of primary prostate cancer (PCa). We present our initial series of 10 consecutive patients who underwent an extended robotic salvage pelvic lymph node dissection (eRSPLND) for 'node-only' recurrent PCa. MATERIALS AND METHODS: It was a prospective study, including patients who presented with biochemical relapse after a primary radical prostatectomy at a median of 3.6 years prior. Clinical work-up that was done, including Magnetic resonance Imaging of chest/abdomen/pelvis and a bone scan, did not reveal any abnormalities. All patients underwent 11Choline PET (Positron Emission Tomography)/CT (Computed Tomography), which identified 'node-only' metastases. RESULTS: The median operative time was 73.4 mins, blood loss of 100 cc and hospital stay of 2 days. No patient had intra-operative complications, required an open conversion or any blood transfusion. Clavien II grade complications occurred in 1 patient (10%) and were managed conservatively. On histopathology, the median number of total and positive nodes per patient was 15 and 6, respectively. Overall, in our 10 patients, of the 157 total excised nodes, 38.8% were positive. Overall the median (range) PSA (prostate specific antigen) pre-operatively was 3.5 (1.6-3.7) ng/ml. At 3 months post-operatively, the median (range) PSA was 1.1 (0.2-3.4) ng/ml. This reflects an overall median PSA decrease of 31.4%. In no patient did the post-eRSPLND (extended Robotic Salvage pelvic lymphadenectomy) PSA reach zero. CONCLUSIONS: eRSPLND allows the majority of patients to postpone hormonal treatment, which can theoretically decrease the cost of the treatment. 11Choline PET/CT identifies patients who are suitable for the eRSPLND. Longer follow-up is necessary to assess the oncologic outcomes.

Robot-assisted laparoscopic ureteral reconstruction: а systematic review of literature.

INTRODUCTION: To review the literature, as well as to analyze and compare available data on robot-assisted laparoscopic (RAL) surgery versus open surgery, carried out in ureteral reconstructions in terms of different surgical characteristics. MATERIALS AND METHODS: Eligible studies, published between 1997 and July 2016, were retrieved through MEDLINE by applying predetermined inclusion and exclusion criteria with the English language restriction. Publications on RAL surgeries, carried out in different ureteral reconstructions and of any study design, including case series and comparative studies, were included. The study was performed in accordance with the PRISMA statement. RESULTS: A total of 12 retrospective studies (case series and comparative studies) met the systematic review selection criteria involving 245 RAL and 76 open ureteral surgery cases. Main indications for ureter reconstruction were strictures, tumors and injuries. The individual results of comparative studies revealed that the EBL was statistically significantly lower for RAL than for open surgery. As for operation time, length of hospital stay and follow-up time, the data was contradictory. The rate of recurrent stricture in RAL and open groups was similar: -9.0%. The meta-analysis of three comparative studies confirmed that patients lose statistically significantly less blood in RAL, compared to open surgery. CONCLUSIONS: The analysis of limited data available shows that robot-assisted laparoscopic ureteral reconstruction is a safe and effective minimally invasive technique with high cure rates similar to those of the conventional open approach and, with favorable safety profile. Future well-designed randomized controlled trials are required to strengthen our findings.

A new method for the evaluation of pelvic organ prolapse in women using a three-dimensional optic scanner.

INTRODUCTION AND HYPOTHESIS: Modern classifications of pelvic floor movements are based on pelvic floor assessment in a static midsagittal plane. This study presents a new and potentially useful 3D noninvasive tool for studying pelvic floor mobility in women with pelvic organ prolapse (POP). MATERIALS AND METHODS: Thirty-four patients with POP [grade ≥3 using the Pelvic Organ Prolapse Quantification (POP-Q) system] and 30 healthy volunteers (controls) at rest and during Valsalva maneuver were scanned using an Artec™ 3D optic portable scanner and 3D pelvic floor models were generated. We calculated the volume of the prolapsed vaginal wall using dynamic prolapse increment (DPI), which is defined as an increase in prolapse volume from rest to its maximal Valsalva probe [DPI = (Vval - Vrest) / Vrest %)]. RESULTS: In the control group, the average DPI was 28 % (16-51 %). As the DPI in patients with POP varied widely, two subgroups were identified. In the first subgroup, the average DPI was 290 % (125-437 %), whereas it was only 48.8 % (41-55 %) in the second subgroup. Prolapse volume in subgroup 1 was not due to the most prominent component of POP but was induced by enlargement of the prolapsed vaginal wall from other components, such as a cystocele or enterocele, which was evident only during the 3D procedure and could not be validated by the POP-Q system. CONCLUSIONS: In addition to existing methods, 3D modelling is a useful tool for evaluating pelvic floor mobility. Further investigation of the pelvic floor dynamic features in women is necessary.

Use of Martius flap in the complex female urethral surgery.

INTRODUCTION: Objectives were to evaluate safety and patient reported perception of the Martius fibroadipose flap for complex female urethra reconstruction. MATERIAL AND METHODS: Patients operated with a Martius flap were contacted again via telephone to rate their self-perception on cosmetic appearance, pain or numbness of the flap harvest site. RESULTS: 37 women (mean age of 46.8 yrs.) were operated with Martius flaps. Complications were limited to bleeding from the flap bed in 19% (7/37); hematomas - 5.4% (2/37); and lymphorrhea from the labial incision in 13.5% (5/37) and labial wound infection in 5.4% of cases (2/37). For self-perception 65% of patients (24/37) were phone interviewed (mean follow up - 54.2 months). Only 17% of women (4/24) complained to cosmetic problems. Two patients (8%) complained to a periodical mild pain. And 12.5% (3/24) of the women had decreased sensation or numbness at the labia. CONCLUSIONS: Martius flap is safe and it is not causing significant complications during female urethral reconstruction. However, an informed consent for decreased sensation and numbness at the flap harvesting area should be obtained.

Necrotising fasciitis after hysterectomy and concomitant transvaginal mesh repair in a patient with pelvic organ prolapse.

Necrotising fasciitis is a severe form of soft tissue infection. Herein, we present an unreported complication of the transvaginal repair of a pelvic organ prolapse (POP) with trocar-guided polypropylene mesh and a concomitant hysterectomy. A 61-year-old Caucasian female who had been using an intrauterine device (IUD) for 30 years presented with a stage 3 pelvic organ prolapse. A genital ultrasound examination confirmed the presence of an IUD, but found no endometrial abnormalities. The surgical management was limited to a transvaginal hysterectomy and simultaneous anterior vaginal wall repair augmented with trocar-guided mesh. A morphological examination of the removed uterus confirmed the presence of the intrauterine device and additionally found endometrial cancer (T1N0M0), which was not revealed during the preoperative ultrasound. Within 6 days of the surgery, she developed anaerobic bilateral necrotising fasciitis on both thighs. Non-clostridial streptococci were identified in the wound. After 18 days of intensive care, the patient died of fatal coagulopathy.