From 3D to 2D-4K laparoscopic sacral colpopexy: are we addicted to technology?

OBJECTIVE: A study analyzing perioperative outcomes related to a sudden switch from 3D to 2D-4K technology for laparoscopic sacral colpopexy by expert pelvic surgeons: are we addicted to technology? MATERIAL AND METHODS: After a sudden transition from 3D to 2D-4K laparoscopic technology, a total of 115 consecutive pelvic prolapse patients who underwent sacral colpopexy from June 2020 to September 2021 were retrospectively assessed from our database. Perioperative parameters, operative times (OT), and intraoperative difficulty scales were assessed. One-year follow-ups were analyzed for the study. Primary endpoints were OT; secondary endpoint was the evaluation of complications linked to this procedure. RESULTS: We found statistical differences in OT and intraoperative difficulty scales between medians of the last 3D procedures and the first ten 2D-4K surgeries, without differences between operators. Only after more than 20 surgeries, we observed no significant differences between 3D and 2D-4K sacral colpopexy. We observed no statistical differences in terms of anatomic failure, PGI-I, and intra-postoperative complications. CONCLUSION: The transition of urogynecology from an exclusive vaginal approach to 2D-3D-4K laparoscopy significantly increased the level of technology necessary for surgical treatment of prolapse. This could, as a result, lead to pelvic surgeons becoming increasingly dependent on technology.

Laparoscopic posterior vaginal plication plus sacral colpopexy for severe posterior vaginal prolapse: A randomized clinical trial.

AIM: A randomized clinical trial proposing a new laparoscopic prosthetic and fascial approach to severe posterior vaginal prolapse. The primary endpoint was to evaluate the objective and subjective outcomes of our laparoscopic posterior plication (LPP) combined to "two-mesh" sacral colpopexy (laparoscopic sacral colpopexy [LSC]) in severe posterior vaginal prolapse, with a 1-year follow-up. The secondary endpoint was to evaluate the safety of this surgical procedure. METHODS: This is single-center prospective randomized double-blinded clinical trial. A total of 130 consecutive patients with anterior and/or apical pelvic organ prolapse (POP) (POP-Q stage ≥II) and severe posterior vaginal prolapse (posterior POP-Q stage ≥III) were prospectively assessed for inclusion into the study from November 2018 to January 2020. Patients underwent "two-meshes" LSC and were randomized in Group A (LSC plus LPP) and Group A (LSC alone). Of the 130 included subjects, 8 were excluded, not meeting inclusion criteria. Cure rate was evaluated objectively, using POP-Q study, and subjectively using PGI-I, POPDI-6, and FSDS questionnaires. Complications were assessed intra-, peri-, and postoperatively. Twelve-month follow-ups were analyzed for the study. RESULTS: We found in LSC plus LPP Group a significant improvement of Ap and genital hiatus POP-Q points. Our subjective study showed, at 12 months, a statistical difference in PGI-I successful outcomes rate in favor of LPP. Also the FSDS resulted significantly much more improved in Group A. We observed no statistical differences in terms of postoperative complications. CONCLUSIONS: Our LPP approach to LSC could be considered an effective and safe technique to POP patients with severe posterior prolapse.

Robot-assisted pelvic floor reconstructive surgery: an international Delphi study of expert users.

BACKGROUND: Robotic surgery has gained popularity for the reconstruction of pelvic floor defects. Nonetheless, there is no evidence that robot-assisted reconstructive surgery is either appropriate or superior to standard laparoscopy for the performance of pelvic floor reconstructive procedures or that it is sustainable. The aim of this project was to address the proper role of robotic pelvic floor reconstructive procedures using expert opinion. METHODS: We set up an international, multidisciplinary group of 26 experts to participate in a Delphi process on robotics as applied to pelvic floor reconstructive surgery. The group comprised urogynecologists, urologists, and colorectal surgeons with long-term experience in the performance of pelvic floor reconstructive procedures and with the use of the robot, who were identified primarily based on peer-reviewed publications. Two rounds of the Delphi process were conducted. The first included 63 statements pertaining to surgeons' characteristics, general questions, indications, surgical technique, and future-oriented questions. A second round including 20 statements was used to reassess those statements where borderline agreement was obtained during the first round. The final step consisted of a face-to-face meeting with all participants to present and discuss the results of the analysis. RESULTS: The 26 experts agreed that robotics is a suitable indication for pelvic floor reconstructive surgery because of the significant technical advantages that it confers relative to standard laparoscopy. Experts considered these advantages particularly important for the execution of complex reconstructive procedures, although the benefits can be found also during less challenging cases. The experts considered the robot safe and effective for pelvic floor reconstruction and generally thought that the additional costs are offset by the increased surgical efficacy. CONCLUSION: Robotics is a suitable choice for pelvic reconstruction, but this Delphi initiative calls for more research to objectively assess the specific settings where robotic surgery would provide the most benefit.

Is There a Role for Bladder Biopsy in the Diagnosis of Non-Hunner Lesions Interstitial Cystitis?

INTRODUCTION: Bladder pain syndrome/interstitial cystitis (BPS/IC) is either Hunner lesion interstitial cystitis (HL IC) or non-Hunner lesion interstitial cystitis (N-HL IC), differing in the presence of HLs on cystoscopy. Cystoscopy is essential in diagnosing HL but are bladder biopsies useful in N-HL IC patients? Our objective was to assess bladder biopsy in patients with N-HL IC, evaluating whether the count of mast cells (MCs) and percentage of activated MCs could measure severity. MATERIALS AND METHODS: This is a single-centre retrospective study. INCLUSION CRITERIA: diagnosis of BPS/IC by ESSIC definition; absence of HLs. Each patient had three bladder biopsies. STATISTICAL ANALYSIS: χ2/Fischer's exact test; Wilcoxon signed-ranks test/Mann-Whitney U test. Statistical significance: p < 0.05. RESULTS: We separated 48 women into Group 1 with <50% of MCs activated and Group 2 with >50%. We compared the results of the O'Leary-Sant questionnaire between the two groups and did not find any correlation between the severity of the pathology and either the MC count in the detrusor or the percentage of activated MCs in the lamina propria or detrusor. DISCUSSION/CONCLUSION: These findings cast doubt on the usefulness of bladder biopsy for the evaluation of severity in N-HL IC.

Local anesthesia for Altis® single incision sling in women with stress urinary incontinence.

OBJECTIVE: Local anesthesia for single incision slings has shown a good objective and subjective cure rate in women with stress urinary incontinence. The aim of the present study was to verify the efficacy and safety of local anesthesia during Altis® single incision placement. MATERIAL AND METHODS: One hundred sixty-six consecutive patients (83 patients for each group: local resp. spinal anesthesia) were selected from our database for this retrospective study among women who underwent an Altis® implantation for SUI from September 2016 to June 2021, after unsuccessful previous conservative treatment. Primary endpoints were objective and subjective cure rates; secondary endpoint was the evaluation of complications linked to this procedure. RESULTS: A total of 155 included patients completed our 12 months follow-up. Baseline characteristics were similar between the groups. Operative time (percentage difference of 50%; p < 0.05) and the Intraoperative Difficulty Scale resulted lower in spinal patients. No differences were found between populations in terms of objective (cough stress test and urodynamics) and subjective (PGI-I and FSDS questionnaires) cure rate and postoperative complications. CONCLUSION: Local anesthesia for Altis® implantation could be considered a safe alternative to spinal anesthesia and an effective opportunity to avoid general anesthesia, increasing the possibility of outpatient implantation of this sling system.

Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up.

INTRODUCTION AND HYPOTHESIS: Following health notification by the FDA in 2008 of serious complications with transvaginal mesh for anterior pelvic organ prolapse, there has been a return to native tissue repairs. Earlier work with a self-retaining support (SRS) implant showed a high anatomical success rate with minimal implant-related complications over a medium-term follow-up. It is proposed that post-implant complications are more a consequence of the method of mesh anchoring rather than the implant itself. Our system incorporates an ultralight mesh with a frame that provides level I, II, and III support without the need for fixation. The first long-term outcomes of SRS implantation are presented. METHODS: A prospective multicenter trial was conducted using two consecutive identical protocols of the use of the SRS implant in women with symptomatic anterior compartment prolapse extending their follow-up to 36 months. Anatomical success (Pelvic Organ Prolapse Quantification stage 0 or 1 or a Ba ≤ -2) was recorded along with subjective success as defined by regular quality-of-life (PFDI-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) assessments. RESULTS: Sixty-seven patients completed 36 months of follow-up. Mean Ba measurements improved from 3.1 (-1 to 6) cm to -2.8 (-1 to -3) cm and C point from 0.4 (-8 to 6) cm to -6.9 (-10 cm to 1) cm. accumulating to a significant anatomical success rate of 94.3%. Subjective success based on question #3 of the PFDI-20, analyzed for the index surgical compartment, reached 95.7%. Post-operative complications included 2 cases of urinary retention, 1 minor frame exposure, 1 case of delayed voiding dysfunction, and 2 cases of de novo stress urinary incontinence. Untreated pre-operative second-degree Bp measurements had increased in 27% at follow-up. CONCLUSION: The long-term outcome of the SRS implant shows an excellent subjective and objective success with minimal risk of complications or need for reintervention.

Sexual and functional outcomes after prolapse surgery: a randomized prospective comparison of trocarless transvaginal mesh and pelvic organ prolapse suspension.

PURPOSE: Stress urinary incontinence (SUI) related to pelvic organ prolapse represents a common condition that negatively impacts female sexual activity. Laparoscopic pelvic organ prolapse surgery (POPs) and the anterior repair with a trocar-less trans-vaginal mesh (TTMs) represent two different surgical techniques to treat SUI secondary to POP. This study aimed to report the results of these techniques comparing the sexual and functional outcome improvement. MATERIALS AND METHODS: Fifty-nine sexually active female patients, complaining of urodynamic stress incontinence, were enrolled in this prospective study, and simply randomized in two groups: 29 POPs and 30 TTMs. All patients were studied at baseline and 6 months after surgery. Preoperative evaluation included medical history, urodynamic test, Female Sexual Function Index (FSFI), and pelvic magnetic resonance defecography. Six months after surgery, all patients completed the FSFI and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and were investigated with a uroflowmetry test with post-void residual volume (PVR). RESULTS: At 6 months after surgery, 87% of POPs patients and 79% of TTMs subjects resulted dry. No statistically significant results were obtained in terms of urinary outcomes between the two surgical groups. Regarding sexual function, POPs group exhibited a significant greater improvement of global FSFI (mean: 27.4; SD: 4.31) compared to TTMs group (mean FSFI: 23.56; SD: 2.28; p-value ≤ 0.0001). CONCLUSIONS: Our results indicated that POPs and TTMs lead to satisfactory and safe functional outcomes with a good recovery of urinary continence. Furthermore, POPs, when compared to TTMs, led to a greater improvement of sexual function.

Laparoscopic ventral rectopexy plus sacral colpopexy: continuous locked suture for mesh fixation. A randomized clinical trial.

PURPOSE: Laparoscopic ventral rectopexy (LVR) plus sacral colpopexy (LSC) is a high-complexity surgical procedure. The aim of the present study was to evaluate a new approach to rectal-mesh fixation during LVR with continuous locked suture. METHODS: This is a prospective randomized double-blinded clinical trial enrolling 80 patients with severe POP and obstructed defecation syndrome (ODS) from November 2016 to January 2021. Patients underwent a "two-meshes" LSC plus LVR and were randomized, regarding rectal mesh fixation, in Group A (extracorporeal interrupted 0 delayed absorbable sutures) and Group B ("U-shaped" running locked 0 delayed absorbable suture). Our primary endpoints were the operative times (OT); the secondary endpoints were the incidence of anatomical failures, vaginal mesh erosions and surgical complications. RESULTS: A total of 75 patients completed the study. Baseline characteristics were similar between the groups. Overall OT (156 vs 138 min; p < 0.05; treatment reduction of 11.5%) and LVR mesh fixation time (29 vs 16 min; p < 0.05; treatment reduction of 44%), resulted in significantly lower in Group B. No differences were found in terms of anatomic failure, vaginal mesh erosion or intra- or post-operative complications. PGI-I, FSDS and Wexner questionnaires resulted significantly improved after surgery, without statistical differences between the studied surgical procedures. CONCLUSION: Laparoscopic continuous locked 0 absorbable suture for LVR mesh fixation guaranteed a faster and effective alternative to multiple interrupted sutures. The significant OT reduction linked to this technique should be considered even more helpful when performing a highly complex surgery such as LVR. CLINICAL TRIAL REGISTRATION: NCT05254860 (13/02/2017).

Titanized polypropylene mesh in laparoscopic sacral colpopexy.

INTRODUCTION: This study investigated perioperative and mid-term clinical outcomes after laparoscopic sacrocolpopexy (LSCP) with light titanium-coated polypropylene (TCP) mesh in a large group of patients affected by International Continence Society stage II-IV pelvic organ prolapse (POP). METHODS: This multicenter retrospective study included 217 patients treated with LSCP using TCP mesh. We aimed to (1) analyze the intra- and postoperative complication rates according to the ICS/IUGA Complication Classification Code guidelines, (2) evaluate the anatomical results and (3) assess postoperative patient satisfaction with the Patient Global Impression Improvement questionnaire. Nonparametric Wilcoxon signed-rank tests, χ2 test and Fisher's exact test were used where appropriate. RESULTS: The intraoperative complications were two (0.9%) cases of hemorrhage, two (0.9%) cases of incidental cystotomy and four (1.8%) cases of incidental colpotomy. During the postoperative follow-up, we recorded mesh exposure in 3 (1.4%) out of 217 patients. These 3 patients were from a group of 22 women who underwent vaginal opening during surgery, while in the remaining 195 patients without incidental colpotomy, no mesh exposure was observed (13.6% vs. 0.0%, p < 0.001). No failure of the apical compartment was observed, while 3 (1.4%) out of 217 patients experienced isolated anterior recurrence, and 1 (0.4%) patient had isolated posterior recurrence. All patients reported PGI-I scores ≥ 3, and 209 patients (96.3%) had a PGI-I score ≥ 2. CONCLUSIONS: The use of light TCP mesh is safe and effective during LSCP for POP repair from both an anatomical and a functional point of view, posing a very low postoperative mesh-related complication risk.

GAG replenishment therapy for bladder pain syndrome/interstitial cystitis.

AIMS: To present a rationale for the inclusion of urothelial coating dysfunction in the etipathogenesis of bladder pain syndrome/interstitial cystitis (BPS/IC) and the preclinical and clinical evidence in support of glycosaminoglycan (GAG) replenishment therapy in the treatment of BPS/IC, supplemented by the clinical experience of medical experts in the field and patient advocates attending a symposium on GAG replenishment at ESSIC'17, the annual Meeting of the International Society for the Study of Bladder Pain Syndrome, held in Budapest, Hungary in 2017. RESULTS: The urothelial GAG layer has a primary role in providing a permeability barrier to prevent penetration of urinary toxins and pathogens into the bladder wall. Disruption of the GAG layer contributes to the development of BPS/IC. The evidence shows that replenishment of GAGs can restore the GAG layer in BPS/IC, reducing inflammation, pain, and other symptoms. CONCLUSIONS: Although data from large randomized controlled studies are limited, long clinical observation and the experience of clinicians and patients support the beneficial effects of intravesical GAG replenishment therapy for providing symptomatic relief for patients with BPS/IC.

Rectal mesh erosion after posterior vaginal kit repair.

INTRODUCTION AND HYPOTHESIS: The present video shows a rare case of erosion through the full rectal wall into the rectum after a transperineal implant of a double-arm polypropylene kit. METHODS: A 70-year-old woman underwent a transperineal implant of a double-arm polypropylene kit. One year after surgery, she developed bothersome symptoms in the posterior perineum including heaviness, pain and rectal bleeding during defecation. A clinical examination showed the presence of a part of the prothesis traversing the rectal cavity. A minimally invasive transanal approach was performed to remove the mesh and restore the rectal integrity. RESULTS: This surgical technique demonstrates rectal mesh removal with a transanal approach. CONCLUSIONS: To our knowledge, this is a rare complication of rectal erosion of a posterior transperineal mesh kit. The aim of this video is to show a complete transanal approach to treating this serious complication avoiding the more invasive and traumatic abdominal procedure.

Adelmidrol + sodium hyaluronate in IC/BPS or conditions associated to chronic urothelial inflammation. A translational study.

Interstitial cystitis/painful bladder syndrome (IC/PBS) is a chronic bladder condition characterized by frequent urination, bladder inflammation and pain. It is a particular challenging disease and a clear unmet medical need in terms of identifying new therapeutic strategies. The aim of study was to evaluate the anti-inflammatory effects of intravesical Vessilen® (a new formulation of 2% adelmidrol (the diethanolamide derivative of azelaic acid) + 0.1% sodium hyaluronate) administration in rodent models of IC/BPS and in IC/BPS patients or other bladder disorders. Acute and chronic animal models of cystitis were induced by a single or repetitive intraperitoneal injections of cyclophosphamide (CYP); patients with IC/BPS or with bladder pain syndrome associated with symptoms of the lower urinary tract treated once weekly by bladder instillation of Vessilen® for 8 weeks. CYP instillation caused macroscopic and histological bladder alterations, inflammatory infiltrates, increased mast cell numbers, bladder pain, increased expression of nitrotyrosine, decreased expression of endothelial tight junction zonula occludens-1. Intravesical Vessilen® treatment was able to ameliorate CYP induced bladder inflammation and pain by inhibiting nuclear factor-κB pathway and inflammatory mediator levels as well as reduced mechanical allodynia and nerve growth factor levels. A significant improvement in quality of life and symptom intensity were evident in patients with IC/BPS or other bladder disorders treated with Vessilen®. Vessilen® could be a new therapeutic approach for human cystitis.

Vaginal mesh repair SYSTEMS for pelvic organ prolapse: Anatomical study comparing transobturator/trangluteal versus single incision techniques.

INTRODUCTION: The present study aim to compare the anatomic landmarks of two pelvic floor repair systems, in order to identify the potential neurovascular lesions related to different mesh fixation techniques. METHODS: Abdominal and perineal dissections of 10 fresh cadavers after prolapse surgery using transobturator/transgluteal versus single incision techniques. Neuro-vascular structures of obturator region and perineum were isolated. Distances between needles and anatomical structures were measured. RESULTS: During transobturator anterior repair, the superficial cannula passed 2.5 ± 0.6 cm medially to the obturator canal. The distance of superficial arm to the anterior obturator vessels was 2.2 ± 0.4 cm. The distance of deep cannula to the posterior obturator vessels branches was 1.3 ± 0.5 cm. In two of these cases we observed a lesion of posterior obturator vessels. During single incision repair the distance between the obturator canal and the superficial arms was 2.3 ± 0.7. The mean distances of superficial arms to the anterior and posterior obturator vessels were, respectively, 2.3 ± 0.5 cm and 3.2 ± 0.7 cm. During transgluteal posterior repair the distance between the cannula guide and the ischial spine was 1.7 ± 0.5 cm while it measured 2.3 ± 0.4 cm when single incision posterior device was placed. CONCLUSIONS: Anterior transobturator system presents an increased risk of posterior obturator vessels branches injury. During posterior transgluteal repair the distance of the ischio-anal fossa to sacrospinous ligament represents a way that could rule against the correct needle positioning with increased risk of pudendal lesions. Single incision approach offers an easier access to the sacrospinous ligament with lower risk of pudendal lesions.

Repetitive transcranial magnetic stimulation for chronic neuropathic pain in patients with bladder pain syndrome/interstitial cystitis.

AIMS: To evaluate the efficacy, safety, and tolerability of repetitive Transcranial Magnetic Stimulation (rTMS) associated with standard drug therapies for neuropathic pain that does not respond to pharmacological treatment alone in patients with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). Secondary goals were to assess the effects of rTMS on Lower Urinary Tract Symptoms (LUTS) and Quality of Life (QOL). METHODS: Fifteen patients with BPS/IC were enrolled in this randomized, double-blind, sham stimulation-controlled, crossover study. Patients were treated for 2 weeks with either real-rTMS (for five consecutive days in 20-min sessions) or sham-rTMS (for five consecutive days in 20-min sessions). After a 6-week washout period, the patients who had previously undergone real-rTMS underwent sham-rTMS, and vice versa. Patients were rated at each visit by means of questionnaires on pain, urinary disturbances, depression, and QOL. RESULTS: The statistical analysis revealed significant effects of real-rTMS, when compared with sham-rTMS, on pain (in the VAS, Functional Neuropathic Pelvic Pain, Neuropathic Pain Symptom Inventory, McGill questionnaire, and Central Sensitization Inventory), urinary LUTS (in the Overactive Bladder Questionnaire score, bladder emptying, and daily urinary frequency), and QOL (in the subscores of the SF-36 related to physical pain and to emotional status). No serious adverse events were reported during the study. CONCLUSIONS: The results of this study show that rTMS applied with an H-coil over the M1 in the area corresponding to the pelvic region in patients with BPS/IC appears to improve chronic pelvic pain (CPP) and associated urinary disorders.

Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse-2-year follow-up.

INTRODUCTION AND HYPOTHESIS: The search for an improved vaginal mesh prompted the development of a new anchorless implant. The objective was to report on outcome after 2 years of a technique using a self-retaining support (SRS) implant. METHODS: Patients with anterior vaginal wall prolapse, with/without apical prolapse, were recruited. Participants underwent surgical repair using the SRS device. Demographic data, pre-surgical Pelvic Organ Prolapse Quantification (POP-Q) scoring, quality of life (QoL) questionnaires (Pelvic Floor Distress Inventory Short Form 20 [PFDI-20], Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 [PISQ-12]), and surgical data were collected. Patients were followed at 2 weeks, 2, 6, 12, and 24 months after surgery. Objective anatomical success was defined using the NIH criteria. RESULTS: Twenty women were recruited for the study with an average age of 62.1 years and an average parity of 4.0 deliveries. Average BMI was 28. Pre-operative mean POP-Q measurements were Aa =1.40 (-1 to 3) cm, Ba = 2.3 (-1 to 6) cm and C = 0.4 (-7 to 6) cm. Surgical time averaged 31.2 min. Estimated blood loss averaged 165 ml. No intra-operative complications were observed. One case (5%) of frame erosion was documented 8 months after surgery. At 2 years' follow-up, mean POP-Q measurements were: Aa = -2.95 (-3 to -2) cm, Ba = -2.85 (-3 to -2) cm, and C point -6.90 (-10 to -3) cm. Seventeen (85%) patients had stage 0 and 3 patients (15%) had stage 1. No mesh erosions or chronic pelvic pain were documented at follow-up. The total PFDI score at follow-up was decreased by 92.8 points (p < 0.0001). CONCLUSIONS: At 2 years' follow-up, the SRS implant was found to be safe, showing no intra-operative or immediate post-operative complications. All women presented with POP-Q measurements of the anterior and apical compartment at normal value (Ba ≤ -2 cm) and statistically significant subjective improvement.

Laparoscopic high uterosacral ligament suspension: an alternative route for a traditional technique.

INTRODUCTION AND HYPOTHESIS: Uterovaginal prolapse treatment is a challenge for the urogynecologist. Surgical management for apical prolapse can be successful with native tissue and uterosacral ligament (USL) fixation. However, some complications have been described, especially with use of the vaginal approach. The aim of this video is to describe an alternative laparoscopic approach to a traditional vaginal procedure to reduce nerve injury and ureteral complications. METHODS: A 75-year-old woman was referred to our unit for symptomatic stage III apical prolapse and underwent laparoscopic USL fixation, according to the technique described herein. RESULTS: This surgical technique was successful in correcting apical prolapse. CONCLUSIONS: This video tutorial may be useful to urogynecologists for improving surgical technique, thus leading to a reduction in the risk of nerve and ureteral complications. The technique offers the possibility of a correct under-vision suture positioning. Laparoscopic USL fixation can be safely performed to treat apical prolapse.

Real-life clinical practice of onabotulinum toxin A intravesical injections for overactive bladder wet: an Italian consensus statement.

PURPOSE: We developed a consensus on best practice in the real-life management of patients with overactive bladder (OAB) with onabotulinumtoxin A (Onabot/A). METHODS: In March 2015, an interdisciplinary conference was convened. Eleven panelists were invited to review the literature, to present their personal experience and to respond to a number of questions from: "when do we propose Onabot/A treatment" to "when do you decide to re-inject a patient?" A summary of findings of the meeting was provided to all panelists for review and approval. RESULTS: The following statements were agreed. Refractory OAB can be defined based on lack of adherence to first- and second-line treatments for OAB regardless of the underlying cause. Onabot/A treatment can be proposed to refractory OAB patients provided they are willing to perform intermittent catheterization if needed. Before treatment, uroflowmetry with post-void residual evaluation is needed to rule out voiding dysfunction, while urodynamics should be done in cases of complicated OAB wet. Urinary tract infection should be ruled out or treated before the injection. The injection can be performed in the endoscopy room, in an out-patient basis, with local anesthesia. Antibiotic prophylaxis should be initiated with oral drugs. A first follow-up visit should be planned 10-15 days after treatment and residual urine checked. Retreatment can be decided on patients' request, when symptoms worsen. CONCLUSIONS: This consensus document provides a guide for the management of refractory OAB patients with Onabot/A in real life. A number of questions about the effectiveness of Onabot/A in real life remain open.

A new approach to supracervical hysterectomy during laparoscopic sacral colpopexy for pelvic organ prolapse: A randomized clinical trial.

AIMS: Laparoscopic sacral colpopexy (LSC) for pelvic prolapse is a complex procedure, characterized by long operative times and, when combined with supracervical hysterectomy, by a high risk of spreading of unsuspected cancerous tissue. The aim of the present study was to compare, in patients who underwent hysterectomy plus LSC for severe POP, different methods for cervical incision and uterine morcellation. METHODS: This is a prospective single Institution randomized double-blinded clinical trial enrolling 124 patients with severe POP from June 2014 to May 2015. Patients underwent laparoscopic supracervical hysterectomy (LSH) plus LSC for pelvic organ prolapse and were randomized in Group 1 (monopolar hook and conventional mechanical morcellator) and Group 2 (bipolar laparoscopic loop and bipolar morcellator), for supracervical incision and uterine morcellation, respectively. Our primary endpoints were the operative times and the secondary endpoints the incidence of intra- or post-operative complications. RESULTS: A total of 50 patients for group completed the study. Baseline characteristics were similar between the groups. Cervical cutting time (32 vs. 3.10 sec; P <0.01), morcellation (4.10 vs. 2.13 min; P <0.01) and operative time (131 vs. 118 min; P <0.05) resulted significantly lower in Group 2. No differences were found in terms of intra- or post-operative complications. CONCLUSIONS: Laparoscopic bipolar loop and morcellator guaranteed a faster and hemostatic tool during supracervical incision and a controlled and rotation-free uterine extraction. The significant surgical time reduction linked to these devices should be considered even more helpful and effective to perform a complex procedure represented by LSH plus LSC. Neurourol. Urodynam. 36:798-802, 2017. © 2016 Wiley Periodicals, Inc.

Management of apical compartment prolapse (uterine and vault prolapse): A FIGO Working Group report.

AIM: Apical prolapse includes descent of the uterus, vagina cuff, or rarely solely of the cervix. It is estimated that women have an 11-19% life-time risk of undergoing surgery for POP. This rate is projected to increase over the next 2-3 decades. In this FIGO working group report we address the conservative and surgical treatment options for apical prolapse. METHODS: The FIGO working group "Pelvic Floor Medicine and Reconstructive Surgery" describes the different treatments for apical prolapse based on the literature evidence, the cost-effectiveness, the degree of difficulty and summed them up with an experts recommendation. RESULTS: Among the conservative treatment options, pessaries are the most successful options since centuries with a low complication rate and low costs. Among the vaginal operative procedures the sacrospinous ligament fixation (SSLF) and the uterosacral ligament suspension (USLS) show comparable outcomes and efficacy with a different, however, rather low complication pattern and a favorable cost-benefit profile. Sacrocolpopexy, independent on the open abdominal, laparoscopic, or robotic-assisted laparoscopic technique has a good durability and quality of life performance. The minimal invasive techniques are as effective as the open abdominal techniques and there is no difference in mesh exposure. CONCLUSION: Vaginal procedures are well described procedures with favorable outcomes and cost-benefit profiles. Sacral colpopexy has a high-effectivity; data on the route of performance and long-term outcome are awaited. The cost with mesh implants are higher compared to the operations with autologous tissue or any conservative treatment and further studies are recommended to evaluate the cure rates in the span of decades and the possible long-term mesh complications. Neurourol. Urodynam. 36:507-513, 2017. © 2015 Wiley Periodicals, Inc.

A randomized, open-label, multicenter study of the efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate versus dimethyl sulfoxide in women with bladder pain syndrome/interstitial cystitis.

AIMS: Intravesical instillation of hyaluronic acid (HA) plus chondroitin sulfate (CS) in women with bladder pain syndrome/interstitial cystitis (BPS/IC) has shown promising results. This study compared the efficacy, safety, and costs of intravesical HA/CS (Ialuril® , IBSA) to dimethyl sulfoxide (DMSO). METHODS: Randomized, open-label, multicenter study involving 110 women with BPS/IC. The allocation ratio (HA/CS:DMSO) was 2:1. Thirteen weekly instillations of HA (1.6%)/CS (2.0%) or 50% DMSO were given. Patients were evaluated at 3 (end-of-treatment) and 6 months. Primary endpoint was reduction in pain intensity at 6 months by visual analogue scale (VAS) versus baseline. Secondary efficacy measurements were quality of life and economic analyses. RESULTS: A significant reduction in pain intensity was observed at 6 months in both treatment groups versus baseline (P < 0.0001) in the intention-to-treat population. Treatment with HA/CS resulted in a greater reduction in pain intensity at 6 months compared with DMSO for the per-protocol population (mean VAS reduction 44.77 ± 25.07 vs. 28.89 ± 31.14, respectively; P = 0.0186). There were no significant differences between treatment groups in secondary outcomes. At least one adverse event was reported in 14.86% and 30.56% of patients in the HA/CS and DMSO groups, respectively. There were significantly fewer treatment-related adverse events for HA/CS versus DMSO (1.35% vs. 22.22%; P = 0.001). Considering direct healthcare costs, the incremental cost-effectiveness ratio of HA/CS versus DMSO fell between 3735€/quality-adjusted life years (QALY) and 8003€/QALY. CONCLUSIONS: Treatment with HA/CS appears to be as effective as DMSO with a potentially more favorable safety profile. Both treatments increased health-related quality of life, while HA/CS showed a more acceptable cost-effectiveness profile.