Perspectives on technology: urethral slings in a post-mesh world.

OBJECTIVES: To detail the history of synthetic mid-urethral slings (SMUSs) and fascial slings, their efficacy, associated complications, and changes to practice that have occurred after the issuing of the 2011 US Food and Drug Administration (FDA) Safety Communication statement on transvaginal mesh (TVM), and to highlight the need for surgical registries and high-quality randomised controlled data to guide recommendations for continence procedures, in view of current concerns regarding mesh. METHODS: A literature search was conducted in EMBASE, PubMed, and the Cochrane Database of systematic reviews to identify articles published from 2011 onward, following the FDA Safety Communication regarding TVM. RESULTS: Prior to the formal FDA Safety Communication in 2011, TVM was considered a safe option for the treatment of both pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The 2011 FDA safety communications and ensuing widely publicised litigation against TVM manufacturers have shifted both surgeon and patient acceptance of mesh products. Several efforts by medical and government bodies have been made to establish ways to monitor the surgical outcomes and safety of mesh products. The Australasian Pelvic Floor Procedure Registry is one such example. Although SMUSs have a long and established safety profile, perceptions of mesh products for SUI have also been negatively affected. The extent of this, however, has yet to be adequately measured through qualitative and quantitative data. The available data suggest it has been difficult for patients and consumers to distinguish between TVM morbidity for POP vs SUI. Furthermore, there remains a lack of high-quality randomised or real-world registry data to definitively exclude the SMUS from the SUI treatment algorithm. Since SMUSs are a viable option for SUI treatment, the concept of a 'post-mesh world' remains contentious. CONCLUSION: Controversies surrounding SMUSs have changed the treatment landscape of SUI. Against the background of significant litigious action following the FDA warnings against mesh use, there has been significant reduction in the uptake of synthetic mesh products. Although there are ample data related to surgical outcomes and safety for both autologous fascial and retropubic SMUSs in carefully selected patients, informed consent and surgical training will be of paramount importance as newer synthetic materials reach clinical maturity.

Distribution of prostatic markers in glands of the female urethra and anterior vaginal wall-a rapid autopsy study.

BACKGROUND: There are varying reports of immunohistochemically detected prostatic marker protein distribution in glands associated with the female urethra that may be related to tissue integrity at the time of fixation. AIM: In this study we used tissue derived from rapid autopsies of female patients to determine the distribution of glandular structures expressing prostate-specific antigen (PSA) and prostate-specific acid phosphatase (PSAP) along the female urethra and in surrounding tissues, including the anterior vaginal wall (AVW). METHODS: Tissue blocks from 7 donors that contained the entire urethra and adjacent AVW were analyzed. These tissue samples were fixed within 4-12 hours of death and divided into 5-mm transverse slices that were paraffin embedded. Sections cut from each slice were immunolabeled for PSA or PSAP and a neighboring section was stained with hematoxylin and eosin. The sections were reviewed by light microscopy and analyzed using QuPath software. OBSERVATIONS: In tissue from all donors, glandular structures expressing PSA and/or PSAP were located within the wall of the urethra and were present along its whole length. RESULTS: In the proximal half of the urethra from all donors, small glands expressing PSAP, but not PSA, were observed adjacent to the and emptying into the lumen. In the distal half of the urethra from 5 of the 7 donors, tubuloacinar structures lined by a glandular epithelium expressed both PSA and PSAP. In addition, columnar cells at the surface of structures with a multilayered transitional epithelium in the distal half of the urethra from all donors expressed PSAP. No glands expressing PSA or PSAP were found in tissues surrounding the urethra, including the AVW. CLINICAL IMPLICATIONS: Greater understanding of the distribution of urethral glands expressing prostatic proteins in female patients is important because these glands are reported to contribute to the female sexual response and to urethral pathology, including urethral cysts, diverticula, and adenocarcinoma. STRENGTHS AND LIMITATIONS: Strengths of the present study include the use of rapid autopsy to minimize protein degradation and autolysis, and the preparation of large tissue sections to demonstrate precise anatomical relations within all the tissues surrounding the urethral lumen. Limitations include the sample size and that all donors had advanced malignancy and had undergone previous therapy which may have had unknown tissue effects. CONCLUSION: Proximal and distal glands expressing prostate-specific proteins were observed in tissue from all donors, and these glands were located only within the wall of the urethra.

A systematic review on the outcomes of local anaesthetic transperineal prostate biopsy.

OBJECTIVE: To conduct a systematic review of the literature to assess the diagnostic ability, complication rate, patient tolerability, and cost of local anaesthetic (LA) transperineal prostate biopsy. METHODS: Two reviewers searched Medline, the Cochrane Library, and Embase for publications on LA transperineal prostate biopsy up to March 2021. Outcomes of interest included cancer detection rates, complication rates, pain assessments and cost. RESULTS: A total of 35 publications with 113 944 men were included in this review. The cancer detection rate for LA transperineal prostate biopsy in patients undergoing primary biopsy was 52% (95% confidence interval [CI] 0.45-0.60; I2 = 97) and the clinically significant cancer detection rate (Gleason≥3 + 4) was 37% (95% CI 0.24-0.52; I2 = 99%). The rate of infection-related complications in the included studies was 0.15% (95% CI 0.0000-0.0043; I2 = 86). The LA transperineal procedures had a low rate of procedural abandonment (26/6954, 0.37%), with the greatest pain scores measured during LA administration. No formal cost analyses on LA transperineal prostate biopsies were identified in the literature. The overall risk of bias in the included studies was high, with considerable study heterogeneity and publication bias. CONCLUSION: Transperineal prostate biopsy performed under LA is a viable option for centres interested in avoiding the risk of infection associated with transrectal biopsy, and the logistical burden of general anaesthesia. Further investigation into LA transperineal prostate biopsy with comparative studies is warranted for its consideration as the standard in prostate biopsy technique.

Development of a conceptual framework for a new patient-reported outcome measure for pain in women following mesh surgery for pelvic floor disorders: a qualitative study.

INTRODUCTION AND HYPOTHESIS: The Australasian Pelvic Floor Procedure Registry (APFPR) collects both clinical and health-related quality of life (HRQoL) data on women undergoing surgery using a prosthesis such as mesh for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The registry lacks a suitable instrument to assess pain in women following mesh surgery for SUI and POP. This qualitative study describes the views on pain following mesh surgery in women and clinicians through the development of a conceptual framework, which may inform the development of a new instrument for the APFPR. METHODS: We conducted semi-structured interviews with women following mesh surgery for POP and SUI (n=17) and clinicians (n=6) in Victoria, Australia. We sought to reveal aspects of any sort of pain after a pelvic floor procedure. Interviews covered sensation, region, continuity of pain, triggers, and the mode and method of administration for a new pain-specific patient-reported outcome measure. Data were analysed using thematic analysis. RESULTS: We identified the important components of pain felt by women with POP and SUI after surgery using mesh. From the seven themes outlined, a conceptual framework was developed compiling related components of pain into six specific domains. CONCLUSIONS: This study identifies the important components of pain felt by women following mesh surgery. It is hoped that the development of a pain-specific PROM, as supported by clinicians, will assist in the timely and appropriate diagnosis and management of POP and SUI.

A systematic review of the surgical management of apical pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: This systematic review (PROSPERO:CRD42022275789) is aimed at comparing qualitatively the success, recurrence, and complication rates of sacrocolpopexy with concomitant hysterectomy, hysteropexy, sacrospinous fixation (SSF) with and without vaginal hysterectomy (VH) and uterosacral fixation (USF) with and without VH. METHODS: A systematic search was performed using Embase, PubMed, Scopus, and Cochrane databases for studies published from 2011, on women with apical pelvic organ prolapse requiring surgical interventions. Risk of bias was assessed via the National Institutes of Health study quality assessment tool. The primary outcomes are the success and recurrence rate of each technique, for ≥12 months' follow-up. Findings were summarised qualitatively. RESULTS: A total of 21 studies were included. Overall significant findings for a high success and low recurrence rate are summarised as: minimally invasive sacrocolpopexy (MISC) is superior to abdominal sacrocolpopexy (ASC); sacrospinous hysteropexy (SSHP) is superior to USF + VH, which is superior to uterosacral hysteropexy and mesh hysteropexy (MHP). Significant findings related to complications include: MISC recorded a lower overall complication rate than ASC except in mesh exposure; USF + VH tends to perform better than SSHP and SSF, with SSHP performing better than MHP in faecal incontinence and overactive bladder rates. CONCLUSION: There is no evidence to conclude that hysterectomy is superior to uterine-sparing approaches. MISC should be considered over ASC given similar efficacy and reduced complications. Superiority of MHP is unproven against native tissue hysteropexy. Further studies under standardised settings are required for direct comparisons between the surgical management methods.

Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common pelvic floor disorders (PFDs). Owing to significant adverse events associated with mesh-related pelvic floor procedures (PFPs) in a proportion of the surgically treated population, and deficits in collection and reporting of these events, the Australian Government identified an urgent need for a tracking mechanism to improve safety and quality of care. The Australasian Pelvic Floor Procedure Registry (APFPR) was recently established following the 2018 Senate Committee Inquiry with the aim of tracking outcomes of PFP involving the use of devices and/or prostheses, with the objective of improving the health outcomes of women who undergo these procedures. This paper will describe the APFPR's aims, development, implementation and possible challenges on the way to its establishment. METHODS: The APFPR has been developed and implemented in accordance with the national operating principles of clinical quality registries (CQRs). The minimum datasets (MDS) for the registry's database have been developed using a modified Delphi process, and data are primarily being collected from participating surgeons. Patient recruitment is based on an opt-out approach or a waiver of consent. Patient-reported outcome measures (PROMs) providing additional health and outcome information will be obtained from participating women to support safety monitoring of mesh-related adverse events. RESULTS: Currently in the Australasian Pelvic Floor Procedure Registry (APFPR) there are 32 sites from various jurisdictions across Australia, that have obtained relevant ethics and governance approvals to start patient recruitment and data collection as of January 2023. Additionally, there are two sites that are awaiting governance review and five sites that are having documentation compiled for submission. Seventeen sites have commenced patient registration and have entered data into the database. Thus far, we have 308 patients registered in the APFPR database. The registry also published its first status report and a consumer-friendly public report in 2022. CONCLUSIONS: The registry will act as a systematic tracking mechanism by collecting outcomes on PFP, especially those involving devices and/or prostheses to improve safety and quality of care.

Women doctors in female urology: current status and implications for future workforce.

OBJECTIVE: To objectively determine the percentage of female trainees and consultants who are interested in their career being focussed on female urology (FU) in order to facilitate the improved planning for the future of this sub-specialty. SUBJECTS AND METHODS: This was an international cross-sectional study spanning 1 year, from December 2018 to December 2019. An anonymous, voluntary survey was generated using the online survey generator Survey monkey® . The survey was sent to urology consultants and trainees who were female from Australia, New Zealand, and Canada. RESULTS: The total response rate to the survey was 61%. Up to 50% of female consultants and trainees selected a career in FU due to their gender, but up to 75% of respondents were also interested in FU of their own accord. Common concerns held by a majority of respondents included both the medical community's and the public's lack of awareness of FU as a component of urological expertise. Despite these concerns, most of the trainees were not concerned regarding their future work opportunities in FU, and many had intentions to pursue a fellowship in FU. CONCLUSION: Female urology is an increasingly popular sub-specialisation of urology, given the steady increase in the intake of female trainees. Similar trends were identified internationally. Urology training in this area will need to continue to increase the community's and the primary health care referrer's awareness in order to ensure the continued success and growth of the sub-specialty.

Long-term oncological outcomes of the Agarwal loop-ligation technique for management of the distal ureter during laparoscopic radical nephroureterectomy.

OBJECTIVES: To describe the Agarwal loop-ligation technique for the management of the distal ureter during laparoscopic radical nephroureterectomy (LRNU) for upper tract urothelial carcinoma (UTUC) and report on long-term oncological outcomes. PATIENTS AND METHODS: In the Agarwal loop-ligation technique, the distal ureteric stump is controlled using endoscopic Endoloop® or PolyLoop® ligation to ensure en bloc excision of the bladder cuff and prevent spillage of upper tract urine into the perivesical space. A retrospective review of the medical records of 76 patients who underwent the Agarwal loop-ligation technique for UTUC at participating centres from July 2004 to December 2017 was performed. Data collected included demographics, perioperative, and long-term oncological outcomes. Survival was calculated using Kaplan-Meier survival analyses. RESULTS AND LIMITATIONS: A total of 76 patients were included. The median age was 71.5 years and median operative time was 4.3 h. The intramural ureter and bladder cuff were completely excised in all patients. Distal surgical margins were clear in all, with only two patients found to have tumour extending to the circumferential surgical margin. There were no cases of perivesical recurrence or port-site metastasis. The 5-year bladder, local, and contralateral recurrence-free survival was 59.6%, 89.0% and 93.5%, respectively. Metastasis-free survival at 5-years was 73.5%. The 5-year overall survival and cancer-specific survival rates were 70.3% and 84.7%, respectively. CONCLUSIONS: We have described the Agarwal loop-ligation technique for the management of the distal ureter in LRNU. This technique complies with oncological principles outlined in the European Association of Urology guidelines, which minimises tumour spillage. Long-term oncological outcomes are satisfactory, with no cases of perivesical recurrence detected in this series.

Urethral bulking agents for the treatment of stress urinary incontinence in women: A systematic review.

AIMS: To perform a systematic review to assess and compare the efficacy and safety of all urethral bulking agents (UBAs) available for the treatment of stress urinary incontinence (SUI) in women. METHODS: This systematic review was conducted in accordance with the PRISMA guideline. A systematic search was conducted using the Ovid Medline, Embase and PubMed databases. Studies were included if they involved women who underwent either Bulkamid®, Macroplastique®, Durasphere®, Coaptite®, or Urolastic® injections for the treatment of SUI. A total of 583 articles were screened with 56 articles included. A qualitative analysis was performed. RESULTS: The newer synthetic UBAs are not inferior to Contigen®, with variable mean success rates of 30%-80% in the short-term. Better long-term success rates were found with Bulkamid® (42%-70%), Coaptite® (60%-75%), and Macroplastique® (21%-80%) on qualitative review. Urinary tract infection rates were similar between bulking agents (4%-10.6%) although temporary acute urinary retention was more commonly associated with Coaptite® (mean: 34.2%), and de novo urgency in Durasphere® (mean: 24.7%). Significant complications such as migration into lymph nodes was reported with Durasphere®. Erosion was reported with Macroplastique®, Coaptite®, and Urolastic®, with a rate as high as 24.6% in one study of Urolastic®. CONCLUSION: Available data support the use of Bulkamid® and Macroplastique®, which has shown a short-term efficacy of 30%-90% and 40%-85% respectively, and long-term efficacy of 42%-70%, and 21%-80%, respectively. Bulkamid® appears to have a more favorable safety profile, with no cases of erosion or migration of product associated with its use. Direct comparisons of UBAs have not been performed.

Efficacy of sacral neuromodulation and percutaneous tibial nerve stimulation in the treatment of chronic nonobstructive urinary retention: A systematic review.

AIM: The aim of this systematic review is to provide an updated report on the efficacy and complications of sacral neuromodulation (SNM) and percutaneous tibial nerve stimulation (PTNS) in the treatment of chronic nonobstructive urinary retention (CNOUR), with a focus on the contemporary technique of SNM utilizing the percutaneous placement of tined leads. METHODS: This systematic review was conducted with the use of PRISMA guidelines and registered with PROSPERO (CRD42020208052). A systematic literature search was conducted in Embase, PubMed, and Cochrane databases. Inclusion criteria include English language and human participants. Exclusion criteria include SNM studies involving less than 10 CNOUR patients, studies containing data obtained using open, surgical implantation of nontined leads, and studies that only reported the test phase success rate with no long-term efficacy data. The risk of bias assessment was conducted using the National Institutes of Health study quality assessment tool. RESULTS: A total of 16 papers studies were included (11 SNM and 5 PTNS) in this review. The success rate for SNM ranges between 42.5% and 100% (median = 79.2%) for the test stimulation phase and 65.5%-100% (median = 89.1%) in the long term. Most SNM studies reported revision and explantation rates of lesser than 20%. The success rate was much lower for PTNS, in the 50%-60% range and complications were minimal. CONCLUSION: SNM using the contemporary percutaneous tined lead implantation technique appears to be an effective treatment for CNOUR and is durable in the long term. Compared to SNM, PTNS appears less efficacious with less evidence supporting its use in CNOUR. Further prospective studies are required to define the role of PTNS in the treatment of CNOUR.

Impact of radical prostatectomy on bladder function as demonstrated on urodynamics study-A systematic review.

AIMS: This study aims to describe the effects of radical prostatectomy (RP) on bladder function by performing a systematic review of urodynamics study findings before and after RP. METHODS: This systematic review was conducted in accordance with the PRISMA guideline and registered on PROSPERO (CRD42020206844). A systematic search was conducted using PubMed, Cochrane, and Embase. Studies were included if they involved men who underwent RP and had urodynamics study performed preoperatively, postoperatively, or both. Studies that included only subgroups of patients based on symptoms were excluded. Three hundred and four articles were screened, with 20 articles included. A qualitative analysis was performed. RESULTS: The rate of baseline bladder outlet obstruction (BOO) pre-RP was 19%-67%. All six studies with comparative data pre- and postoperatively demonstrated a decrease in the rate of patients with equivocal or clear obstruction. The baseline rates of detrusor overactivity (DO) varied widely from 11% to 61.2%. Six of eight studies with 6 months or more follow-up showed an improvement in the rates of DO ranging from 3.0% to 12.5%. The rate of de novo DO ranged from 0% to 54.5%. Four studies reported an increased rate of impaired bladder contractility and two of three studies showed a worsening rate of impaired bladder compliance following RP. This review is limited by the absence of level I/II studies. CONCLUSIONS: Urodynamics study shows that BOO is improved following RP in most patients. RP resolves DO in some patients and cause de novo DO in others. The net effect is a reduced overall rate of DO in most studies. Bladder compliance and contractility may be impaired after RP.

Adopting a collaborative approach in developing a prehabilitation program for patients with prostate cancer utilising experience-based co-design methodology.

PURPOSE: Engaging patients in a prehabilitation program prior to commencement of cancer treatment is a known challenge. Utilising experience-based co-design (EBCD) methodology, this study aimed to explore the prostate cancer treatment journey from the perspectives of the patient and health professionals and collaboratively develop a prehabilitation program for patients with prostate cancer. METHODS: EBCD was utilised for this study. Patients, support persons and health professionals were selectively identified and recruited from two metropolitan health services in Melbourne. Selection criteria included (i) recent clinical/patient experience with prostate cancer treatment and (ii) willingness to share positive experiences and challenges in two 2-hour face-to-face workshops. Findings from these workshops were thematically analysed to identify key themes addressing aims of the study. RESULTS: Twenty participants including eight patients, one support person and 11 health professionals were recruited. Four key touchpoints were identified. All participants acknowledged positive interactions between patients and health professionals. Patients often described the journey as lonely, stressful and frustrating especially prior to commencement of treatment. A lack of a consistent approach in identifying and preparing patients with prostate cancer for treatment was identified. A structured prehabilitation program was proposed as a solution. Practical ideas to be implemented including timing of commencement, educational content and strategies to boost engagement were formulated. CONCLUSIONS: The findings from the study provided practical guidance for future clinicians when implementing a prehabilitation program. Future study is required to evaluate the effectiveness of such a prehabilitation program in improving patient engagement and preparedness for prostate cancer treatment.

Optimising the tension of an autologous fascia pubovaginal sling to minimize retentive complications.

AIM: To determine the optimal degree of pubovaginal slings (PVS) tension, measured by lax sling dimensions to minimize the risk of urinary retention. METHODS: This prospective study analyzed female patients undergoing PVS for stress urinary incontinence (SUI) by two surgeons over 24 months from January 2016. Intra-operative measurements of lax sling dimensions tented over rectus fascia were recorded. Logistic regression was used to analyse the likelihood of urinary retention (more than 3 months of intermittent self-catheterisation (ISC) or surgical revision) for given PVS dimensions. The secondary analysis assessed for an association between PVS measurements and persistent SUI. RESULTS: Fifty-one patients were recruited with a median age of 53 (34-78) and follow-up of 11 (3-20) months. All but one patient reported improvement of SUI. Ten (19.6%) patients developed postoperative urinary retention. Five (9.8%) resolved after a temporary period of ISC. The other five (9.8%) required ongoing ISC or sling division. A strong association existed between short sling height and prolonged urinary retention (P = 0.00). Receiver operating characteristic (ROC) curve analysis showed a sling height of 40 mm had a sensitivity of 100% and specificity of 51% for retentive complications (area under curve [AUC] = 0.90). Lax sling height up to 60 mm was not associated with persistent SUI. CONCLUSIONS: Stretching the sling suspension sutures at least 40 mm above the rectus fascia was associated with a lower risk of urinary retention than less than 40 mm. This simple technique would appear to be worth evaluating in a larger sample. A looser sling did not compromise the cure of SUI at a mean follow-up of 11 months.

The "G-Spot" Is Not a Structure Evident on Macroscopic Anatomic Dissection of the Vaginal Wall.

BACKGROUND: Controversy exists in the literature regarding the presence or absence of an anatomic "G-spot." However, few studies have examined the detailed topographic or histologic anatomy of the putative G-spot location. AIM: To determine the anatomy of the anterior vaginal wall and present detailed, systematic, accessible findings from female cadaveric dissections to provide anatomic clarity with respect to this location. METHODS: Systematic anatomic dissections were performed on 13 female cadavers (32-97 years old, 8 fixed and 5 fresh) to characterize the gross anatomy of the anterior vaginal wall. Digital photography was used to document dissections. Dissection preserved the anterior vaginal wall, urethra, and clitoris. In 9 cadavers, the vaginal epithelial layer was reflected to expose the underlying urethral wall and associated tissues. In 4 cadavers, the vaginal wall was left intact before preservation. Once photographed, 8 specimens were transversely sectioned for macroscopic inspection and histologic examination. OUTCOMES: The presence or absence of a macroscopic anatomic structure at detailed cadaveric pelvis dissection that corresponds to the previously described G-spot and gross anatomic description of the anterior vaginal wall. RESULTS: Deep to the lining epithelium of the anterior vaginal wall is the urethra. There is no macroscopic structure other than the urethra and vaginal wall lining in the location of the putative G-spot. Specifically, there is no apparent erectile or "spongy" tissue in the anterior vaginal wall, except where the urethra abuts the clitoris distally. CLINICAL IMPLICATIONS: The absence of an anatomic structure corresponding to the putative G-spot helps clarify the controversy on this subject. STRENGTHS AND LIMITATIONS: Limitations to this study include limited access to specimens immediately after death and potential for observational bias. In addition, age, medical history, and cause of death are not publishable for privacy reasons. However, it is one of the most thorough and complete anatomic evaluations documenting the anatomic detail of the anterior vaginal wall. CONCLUSION: The G-spot, in its current description, is not identified as a discrete anatomic entity at macroscopic dissection of the urethra or vaginal wall. Further insights could be provided by histologic study. Hoag N, Keast JR, O'Connell HE. The "G-Spot" Is Not a Structure Evident on Macroscopic Anatomic Dissection of the Vaginal Wall. J Sex Med 2017;14:1524-1532.