Comparing Patient-Reported Outcome Measures for Pain in Women With Pelvic Floor Disorders: A Scoping Review.

Women with pelvic floor disorders (PFDs) typically undergo surgery involving transvaginal mesh implants; however, transvaginal mesh surgery is associated with many adverse events including post-surgical pain. Assessment of pain as a symptom is necessary using patient-reported outcome measures (PROMs). This scoping review aimed to describe and compare existing PROMs previously used to measure pain in women with PFDs. A scoping search of Ovid MEDLINE, EMBASE, CINAHL Plus, Ovid PsycInfo, and grey literature was conducted. Studies published in English describing the development, implementation, and application of PFD-associated pain PROMs among adult women before and after pelvic floor surgery were included. From each article, a descriptive summary organised by study first author, publication year, country, setting, aim, study characteristics, and results were extracted. From 2,604 articles identified, 54 studies were included, describing 44 PROMs. Most studies described at least 2 to 3 instruments. The Pelvic Floor Distress Inventory-20 was most commonly described by 12 studies followed by the Patient Global Impression of Improvement scale. Of the 44 PROMs, 27 were condition-specific, of which 9 included items on pain; 17 generic PROMs, 4 of which contained items on pain; and 6 pain-specific PROMs. PROMs identified in our review measured pain not related to PFDs or pelvic floor surgery and quantified the pain experienced. These PROMs did not measure all areas of pain including region, sensation, impact, and triggers. The findings of this review will assist with developing a new pain-specific PROM in this population. PERSPECTIVE: Women with pelvic floor disorders often undergo surgery involving transvaginal mesh, from which they experience debilitating pain. Pain is a major issue impacting women's lives. Patient-reported outcome measures can be used to assess the pain; however, it is unclear whether existing instruments are relevant.

What credentials are required for robotic-assisted surgery in reconstructive and functional urology?

Introduction: The increasing popularity of robotic assisted surgery (RAS) as it is implemented in to sub specialities poses many challenges to ensuring standards in quality and safety. The area of Reconstructive and Functional Urology (RFU) has a wide range and largely complex heterogeneous procedures. In recent years RFU has started to incorporate RAS as the primary method to undertake these procedures due to improved vision, dexterity, and access to deep cavities. To ensure patient safety majority of institutions maintain minimal requirements to operate using RAS however across specialities and institutions these greatly vary. Methods: A narrative review of all the relevant papers known to the author was conducted. Results: Specific challenges facing RFU is the inability to rely on case numbers as a surrogate means to measure competency as well the ongoing consideration of how to differentiate between surgeons with robotic training and those with the clinical experience specific to RFU. Conclusion: This review explores current models of training and credentialling and assess how it can be adapted to suggest a standardised guideline for RFU to ensure the highest standards of patient care.

Factors associated with polyacrylamide hydrogel outcomes in women with stress urinary incontinence.

Knowledge of factors associated with superior outcomes in women treated with urethral bulking agents for stress urinary incontinence (SUI) remains limited. The aim of this study was to examine associations between post-treatment outcomes in women who had undergone polyacrylamide hydrogel injections for SUI, and physiological and self-reported variables captured during pre-treatment clinical evaluation. A cross-sectional study was undertaken in female patients treated for SUI with polyacrylamide hydrogel injections by a single urologist between January 2012 and December 2019. Post-treatment outcome data were gathered in July 2020 using the Patient Global Impression of Improvement (PGI-I), Urinary Distress Inventory-short form (UDI-6), Incontinence Impact Questionnaire (IIQ7), and International Consultation on Incontinence Questionnaire Short Form (ICIQ SF). All other data were gathered from women's medical records including pre-treatment patient-reported outcomes. Associations between post-treatment outcomes and pre-treatment physiological and self-reported variables were investigated using regression models. One hundred seven of the 123 eligible patients completed post-treatment patient-reported outcome measures. Mean age was 63.1 years (range 25-93 years), and median time between first injection and follow-up was 51 months (inter-quartile range 23.5-70 months). Fifty-five (51%) women had a successful outcome based on PGI-I scores. Women with type 3 urethral hypermobility pre-treatment were more likely to report treatment success (PGI-I). Poor bladder compliance pre-treatment was associated with greater urinary distress, frequency and severity (UDI-6 and ICIQ) post-treatment. Older age was associated with worse urinary frequency and severity (ICIQ) post-treatment. Associations between patient-reported outcomes and time between first injection and follow-up were trivial and not statistically significant. Severity of pre-treatment incontinence impact (IIQ-7) was associated with worse incontinence impact post-treatment. Type 3 urethral hypermobility was associated with a successful outcome, whereas pre-treatment incontinence impact, poor bladder compliance and older age were associated with poorer self-reported outcomes. Long-term efficacy appears to hold in those who responded to initial treatment.

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.

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.

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.

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.

Impact of radiotherapy for localized prostate cancer on bladder function as demonstrated on urodynamics study: A systematic review.

INTRODUCTION: This study aimed to describe the effects of bladder function following radiotherapy for localized prostate cancer by performing a systematic review on studies reporting on urodynamic findings after radiotherapy. METHODS: This systematic review was conducted in accordance with PRISMA guidelines. The review protocol was registered at PROSPERO (CRD42021229037). A systematic search was conducted using PubMed, Cochrane Library, Scopus, and OVID Embase. Studies were included if they involved men who underwent urodynamic studies following radiotherapy for localized prostate cancer. A total of 798 articles were screened and five articles included. A qualitative analysis was performed. RESULTS: Bladder compliance appears to be impaired following radiotherapy, especially with longer followup. Impaired bladder compliance was reported in 18.8-62.5% of patients following radiotherapy. Bladder capacity was found to be statistically significantly lower following radiotherapy compared to pre-radiotherapy, and when compared with patients who did not undergo pelvic radiotherapy. Bladder outlet obstruction (BOO) persists post-radiotherapy in most patients at three and 18 months post-radiotherapy. De novo detrusor overactivity (DO) of 13.3% has been reported at 18 months post-radiotherapy. This review is limited by the absence of level I/II studies. CONCLUSIONS: Radiotherapy for localized prostate cancer results in decreased bladder compliance and capacity demonstrated on urodynamic studies. Resolution of BOO appears less likely in comparison to series on radical prostatectomy. De novo DO may develop following radiotherapy, especially with longer followup. With only low level of evidence studies available at present, further high-quality, prospective studies are important to elucidate the impact of radiotherapy on bladder and urethral function.

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.

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.

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.

Local versus general anesthesia transperineal prostate biopsy: Tolerability, cancer detection, and complications.

Objectives: To compare data on transperineal template biopsy (TPTB) under general anesthesia (GA) compared with local anesthesia (LA) procedures using the PrecisionPoint™ Transperineal Access System (PPTAS) in relation to tolerability, cancer detection rate, complications, and cost. Methods: A prospective pilot cohort study of patients undergoing transperineal biopsy was performed. Patients were excluded if they had concurrent flexible cystoscopy or language barriers. Patients had a choice of GA or LA. A prospective questionnaire on Days 0, 1, 7, and 30 was applied. The primary outcome was patient tolerability. Secondary outcomes were cancer detection rate, complication rate, and theater utilization. Results: This study included 80 patients (40 GA TPTB and 40 LA PPTAS). Baseline characteristics including age, prostate-specific antigen (PSA), digital rectal examination (DRE), findings, and prostate volume were comparable between the groups (p = 0.3790, p = 0.9832, p = 0.444, p = 0.3939, respectively). Higher median prostate imaging-reporting and data system (PI-RADS) score of 4 (interquartile range [IQR] 2) versus 3 (IQR 1) was noted in the LA group (p = 0.0326). Pain was higher leaving recovery in the GA group however not significantly (p = 0.0555). Median pain score at LA infiltration was 5/10 (IQR 3), with no difference in pain at Days 1, 7, or 30 (p = 0.2722, 0.6465, and 0.8184, respectively). For GA versus LA, the overall cancer detection rate was 55% versus 55% (p = 1.000) with clinically significant cancer in 22.5% versus 35% (p = 0.217). Acute urinary retention (AUR) occurred in 5% of GA and 2.5% of LA patients (p = 1.000). The GA cohort spent longer in theater and in recovery with a median of 93.5 min versus 57 min for the LA group (p = <0.0001). Conclusion: This study demonstrates that transperineal biopsy is safely performed under LA with no difference between the cohorts in relation cancer detection or AUR. LA biopsy also consumed less theater and recovery resources. A further larger prospective randomized controlled trial is required to confirm the findings of this study.

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.

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.

Urinary and faecal incontinence: psychological factors and management recommendations.

BACKGROUND: Urinary and faecal incontinence substantially impacts upon physical health and is associated with significant psychological distress and reduced quality of life. Due to stigma and embarrassment, many patients do not present for management of their incontinence. AIM: The objective of this article is to summarise the forms and causes of urinary and faecal incontinence, highlight the psychological mechanisms and psychopathology associated with incontinence, and provide management recommendations. CONCLUSION: Urinary and faecal incontinence can have a significant impact on an individual's psychological wellbeing and quality of life. Psychological factors may either contribute to or arise from incontinence and should be addressed as part of the overall management plan.