What is the best first choice oral drug therapy for OAB?

AIMS: The management of overactive bladder (OAB) involves lifestyle changes and conservative measures in the first instance with the use of liquid/dietary advice, weight loss, and bladder training. Thereafter oral pharmacotherapy is instigated in symptomatic patients. Antimuscarinics and beta 3 agonists form the main classes of drug therapy in this field. Views on what is the best first line OAB treatment is changing based on recent evidence and adverse event profiles of these medications. METHODS: At the ICI-RS meeting 2023, Bristol, UK this topic was discussed and debated as a proposal. The following article summarizes the concepts presented that day as well as the interactive discussion that took place thereafter. RESULTS: OAB guidelines are moving in many circumstances to an either antimuscarinic or beta 3 agonist approach based on patient factors. Several studies have raised concerns on the long-term impact of antimuscarinics, in relation to cognition, dementia, cardiovascular events, and mortality all related to antimuscarinic load. Neither antimuscarinics nor beta 3 agonists have good persistence and adherence rates in the medium to long term. Several barriers also exist to prescribing including guidelines recommending utilizing drugs with the lowest acquisition cost and "step therapy." A newer approach to managing OAB is personalized therapy in view of the many possible etiological factors and phenotypes. These concepts are highlighted in this article. CONCLUSIONS: Current oral pharmacotherapy in managing OAB is limited by adverse events, adherence and persistence problems. Both antimuscarinics and beta 3 agonists are efficacious but most clinical trials demonstrate significant placebo effects in this field. Personalizing treatment to the individual seems a logical approach to OAB. There is a need for better treatments and further studies are required of existing treatments with high quality longer term outcomes.

Should hormone replacement therapy (any route of administration) be considered in all postmenopausal women with lower urinary tract symptoms? Report from the ICI-RS 2023.

AIMS: This International Consultation on Incontinence-Research Society report aims to summarize the evidence and uncertainties regarding the use of hormone replacement therapy by any route in the management of lower urinary tract symptoms (LUTS) including recurrent urinary tract infections (rUTI), with a review of special considerations for the elderly. Research question proposals to further this field have been highlighted. METHODS: An overview of the existing evidence, guidelines, and consensus regarding the use of topical or systemic estrogens in the management of LUTS. RESULTS: There are currently evidence and recommendations to offer topical estrogens to postmenopausal women with overactive bladder symptoms as well as postmenopausal women with rUTIs. Systemic estrogens however have been shown in a meta-analysis to have a negative effect on LUTS and, therefore are not currently recommended. CONCLUSIONS: Although available evidence and recommendations exist for the use of topical estrogens, few women are commenced on these in primary care. There remain large gaps still within our knowledge of the use of estrogens within the management of LUTS, particularly on when it should be commenced, the length of time treatment should be continued for, and barriers to prescribing.

Nocturia in Menopausal Women: The Link Between Two Common Problems of the Middle Age.

INTRODUCTION AND HYPOTHESIS: The aim of this review is to discuss the link between menopause and nocturia and to give an overview of the increasing prevalence, risk factors, causative factors, treatment needs and options for nocturia in peri-menopausal women. METHODS: This opinion article is a narrative review based on the expertise and consensus of a variety of key opinion leaders, in combination with an extensive literature review. This literature search included a thorough analysis of potential publications on both the PubMed Database and the Web of Science and was conducted between November 2022 and December 2022. The following key words were used "nocturia" and "menopause" or "nocturnal frequency and menopause." Moreover, key words including "incidence," "prevalence," "insomnia," "estrogen therapy," "metabolic syndrome," and "hot flushes" were used in combination with the aforementioned key words. Last, the reference lists of articles obtained were screened for other relevant literature. RESULTS: The perimenopause can be a trigger for inducing nocturia. Typically, obesity, body mass index (BMI), and waist circumference are risk factors for developing peri-menopausal nocturia. Presumably the development of peri-menopausal nocturia is multifactorial, with interplay among bladder, sleep, and kidney problems due to estrogen depletion after the menopause. First, impaired stimulation of estrogen receptors in the urogenital region leads to vaginal atrophy and reduced bladder capacity. Moreover, menopause is associated with an increased incidence of overactive bladder syndrome. Second, estrogen deficiency can induce salt and water diuresis through blunted circadian rhythms for the secretion of antidiuretic hormone and the activation of the renin-angiotensin-aldosterone system. Additionally, an increased incidence of sleep disorders, including vasomotor symptoms and obstructive sleep apnea signs, is observed. Oral dryness and a consequent higher fluid intake are common peri-menopausal symptoms. Higher insulin resistance and a higher risk of cardiovascular diseases may provoke nocturia. Given the impact of nocturia on general health and quality of life, bothersome nocturia should be treated. Initially, behavioral therapy should be advised. If these modifications are inadequate, specific treatment should be proposed. Systemic hormone replacement is found to have a beneficial effect on nocturia, without influencing sodium and water clearance in patients with nocturnal polyuria. It is presumed that the improvement in nocturia from hormonal treatment is due to an improvement in sleep disorders.

Mixed urinary incontinence: Are there effective treatments?

The aim of this debate article is to discuss whether effective treatments are available for mixed urinary incontinence (MUI). Because patients with MUI have both stress and urgency urinary incontinence (SUI and UUI) episodes and current treatment guidelines currently recommend treating the predominant symptom first, this article presents standard and emerging treatments for both SUI and UUI before discussing how well these treatments meet the medical needs of patients with MUI. Standard treatments presented include noninvasive options such as lifestyle changes and pelvic floor exercises, pharmacological agents, and surgery. Treatment of all three types of urinary incontinence (UI) is usually initiated with noninvasive options, after which treatment options diverge based on UI subtype. Multiple pharmacological agents have been developed for the treatment of UUI and overactive bladder, whereas surgery remains the standard option for SUI and stress-predominant MUI. The divide between UUI and SUI options seems to be propagated in emerging treatments, with most novel pharmacological agents still targeting UUI and even having SUI and stress-predominant MUI as exclusion criteria for participation in clinical trials. Considering that current treatment options focus almost exclusively on treating the predominant symptom of MUI and that emerging pharmacological treatments exclude patients with stress-predominant MUI during the development phase, effective treatments for MUI are lacking both in standard and emerging practice. Ideally, agents with dual mechanisms of action could provide symptom benefit for both the stress and urgency components of MUI.

International Urogynaecology Consultation chapter 1 committee 4: patients' perception of disease burden of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: This manuscript from Chapter 1 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) reports on the patients' perception of disease burden associated with pelvic organ prolapse. MATERIALS AND METHODS: An international group containing a team of eight urogynaecologists, a physiotherapist and a statistician performed a search of the literature using pre-specified search terms in PubMed and Embase (January 2000 to August 2020). The division of sections within this report includes: (1) perception of POP and the relationship with body image and poor health; (2) a vaginal bulge as it impacts health and wellbeing in women; (3) the impact of POP on sexual life; (4) body image and pelvic floor disorders; (5) POP and mood; (6) appropriate use of treatment goals to better meet patients' expected benefits; (7) using health-related quality of life questionnaires to quantify patients' perception of POP; (8) The financial burden of POP to patients and society. Abstracts were reviewed and publications were eliminated if not relevant or did not include populations with POP or were not relevant to the subject areas as noted by the authors. The manuscripts were next reviewed for suitability using the Specialist Unit for Review Evidence (SURE) checklists for cohort, cross-sectional and case-control epidemiologic studies. RESULTS: The original individual literature searches yielded 2312 references of which 190 were used in the final manuscript. The following perceptions were identified: (1) women were found to have varying perceptions of POP including shame and embarrassment. Some regard POP as consequence of aging and consider there is no effective therapy. (2) POP is perceived as a vaginal bulge and affects lifestyle and emotional wellbeing. The main driver for treatment is absence of bulge sensation. (3) POP is known to affect frequency of sexual intercourse but has less impact on satisfaction. (4) Prolapse-specific body image and genital self-image are important components of a women's emotional, physical and sexual wellbeing. (5) POP is commonly associated with depression and anxiety symptoms which impact HRQoL although are not correlated with objective anatomical findings. (6) Patient-centered treatment goals are useful in facilitating communication, shared decision-making and expectations before and after reconstructive surgery. (7) Disease-specific HRQoL questionnaires are important tools to assess bother and outcome following surgery, and there are now several tools with Level 1 evidence and a Grade A recommendation. (8) The cost of POP to the individual and to society is considerable in terms of productivity. In general, conservative measures tend to be more cost-effective than surgical intervention. CONCLUSIONS: Patients' perception of POP varies in different patients and has a far-reaching impact on their overall state of health and wellbeing. However, recognizing that it is a combination of body image and overall health (which affects mental health) allows clinicians to better tailor expectations for treatment to individual patients. There are HRQoL tools that can be used to quantify these impacts in clinical care and research. The costs to the individual patient (which affects their perception of POP) is an area that is poorly understood and needs more research.

A randomized, placebo-controlled clinical development program exploring the use of litoxetine for treating urinary incontinence.

AIMS: To investigate the safety and efficacy of litoxetine, a serotonin reuptake inhibitor, in treating urinary incontinence (UI) and mixed urinary incontinence (MUI). METHODS: Two randomized, double-blind, placebo-controlled clinical trials (RCT1 and RCT2) were conducted. RCT1, which included 196 women aged 18-75 with MUI randomized 1:1:1:1 to receive 10, 20, or 40 mg litoxetine or placebo orally twice daily (BID) for 12 weeks, investigated the efficacy (including changes in patient reported outcomes) and safety of litoxetine compared to placebo. RCT2, which included 82 men and women aged 18-70 with any UI type randomly assigned 2:1 to receive 30 mg litoxetine or placebo orally BID for 8 weeks including a 2 week dose titration period, investigated the safety (including psychiatric safety) and efficacy of litoxetine compared to placebo. Efficacy was measured as the change in number of incontinence episodes per week and assessed using an analysis of covariance with missing data imputed by Predictive Mean Matching. Safety was assessed by adverse events (AEs) and physical examinations and analyzed using descriptive statistics. RESULTS: The 30-mg and placebo groups in RCT2 showed no difference in frequency of AEs, and litoxetine reduced the number of incontinence episodes per week compared to placebo. Although RCT1 suffered an unexpectedly high placebo response, and therefore did not meet the primary efficacy endpoint, 71% of participants receiving 40 mg litoxetine reported a clinically meaningful improvement in the King's Health Questionnaire. CONCLUSIONS: Litoxetine may be a safe, effective and well-tolerated treatment for patients with UI.

Defining nocturnal polyuria in women.

AIMS: Nocturnal polyuria (NP) is defined by the International Continence Society (ICS) as "excessive production of urine during the main sleep period" and is one of the main causes of nocturia. The ICS recognized that "excessive" is not clearly defined and that this needs to be highlighted in both clinical and research settings. The aim of this study was to identify different definitions of NP and apply them to a population of women attending the Urogynaecology clinic. METHODS: This was a retrospective study of complete bladder diaries collected from women attending a tertiary Urogynaecology Unit. Six different definitions were identified and were divided into "absolute," "relative," and "functional definitions." Prevalence data were calculated and values generated for sensitivity, specificity, positive and negative predictive values when related to women voiding ≥ 2 times per night. RESULTS: Complete bladder diaries were obtained from 1398 women, over 6 years, with a mean age of 57 years. Prevalence varied across the definitions from 21.5% (absolute definition) to 77% (relative definition). Sensitivity ranged from 43% (absolute) to 87% (relative). The definitions that showed the highest combined sensitivity and specificity were the functional definitions. CONCLUSION: From this study it is clear that more work needs to be done to arrive at a consensus for defining NP to enable accurate diagnosis and development of treatment pathways. We propose that a relative definition may provide a more clinically relevant method of defining NP.

Shifting the treatment paradigm in idiopathic overactive bladder.

PURPOSE: Overactive Bladder (OAB) is a common condition that is known to have a significant impact on Health Related Quality of Life (HRQoL). Whilst all patients will initially benefit from lifestyle modifications and behavioural therapy in the first instance drug therapy remains integral in management pathways. The purpose of this review paper is to reappraise the evidence based approach to the management of OAB in addition to exploring a new treatment algorithm for the escalation of treatment in those patients with refractory symptoms. DESIGN: Literature Review RESULTS: Antimuscarinic drugs are currently the most commonly used medication although the introduction of mirabegron, a ß3 agonist, has provided an alternative and also allowed combination therapy in those patients who have failed to improve on primary therapy or who have troublesome side effects. For those patients with symptoms of refractory OAB more invasive therapies including OnabotulinumtoxinA, sacral neuromodulation and Percutaneous Tibial Nerve Stimulation (PTNS) may be indicated. CONCLUSION: We propose a new, evidence based, treatment algorithm for the management of OAB in patients who remain refractory to first line therapy.

The use of 3D ultrasound in comparing surgical techniques for posterior wall prolapse repair: a pilot randomised controlled trial.

The most appropriate method for repairing posterior vaginal wall prolapse is still debatable. Women with symptomatic prolapse scheduled to undergo surgical repair in the posterior compartment were randomised to standard posterior colporrhaphy (SPC) or fascial and vaginal epithelial plication (FEP). Participants were assessed with the Prolapse Quality of Life (P-QOL) questionnaire, pelvic organ prolapse quantification (POP-Q) examination and three-dimensional ultrasound (3D US) prior to surgery and 6 months postoperatively. The research hypothesis is that 3D US of the pelvic floor is a reliable tool in comparing the anatomical outcomes of the two different surgical techniques. Differences in anatomical outcomes, assessed clinically and by ultrasonographic evaluation, were compared between the two groups using the Independent Mann-Whitney U-test and the Wilcoxon signed-rank sum test. Twenty-two women were included in the analysis. Six months postoperatively, women in the FEP arm had better anatomical outcomes compared to those who had undergone SPC (p = .02). Repeatability of the ultrasound technique was confirmed, showing moderate to very good agreement in all parameters and the 3D US evaluation was corroborated with the clinical examination, showing a greater reduction in the urogenital size in the FEP group.Impact statementWhat is already known on this subject? The low cost and universal availability of the ultrasound (US) makes it the most commonly used diagnostic modality. The ability to see beyond surface anatomy is important and useful in the assessment of the posterior vaginal wall prolapse and the obstructed defaecation, where this method may replace the defaecation proctography (Dietz 2019). Recent advances in pelvic floor ultrasonography (3D US) have achieved repeatability in the measurement of the levator hiatal (LH) dimensions, introducing a valid and readily available tool for researchers and clinicians (Dietz et al. 2005). Ultrasound may distinguish a true rectocele due to the weakening of the rectovaginal fascia from an enterocele, a rectal intussusception, or just a deficient perineum (Guzman Rojas et al. 2016).What do the results of this study add? Our study demonstrates that 3D translabial pelvic floor ultrasound is a useful and reliable tool in assessing the anatomical outcome of prolapse surgery.What are the implications of these findings for clinical practice and/or further research? Our study demonstrates that 3D translabial ultrasound of the pelvic floor is a useful and reproducible method in evaluating the anatomical outcomes of surgical repair for posterior wall prolapse. Genital hiatus (GH) and levator hiatus (LH) dimensions measured by ultrasound can be used as surrogate anatomical markers in comparing the efficacy of different surgical techniques.

Is there enough evidence to justify the use of laser and other thermal therapies in female lower urinary tract dysfunction? Report from the ICI-RS 2019.

AIMS: There is increasing evidence to suggest that thermomodulation may have a role in the management of women with lower urinary tract dysfunction (LUTD) and there has been widespread adoption of laser and radiofrequency (RF) therapies within clinical practice. However, in many areas of LUTD, the data are still limited and there remains a need for further evaluation of the safety and efficacy of thermal therapy. The aim of this study proposal is to report the findings of the International Consultation on Incontinence Research Society to clarify our current knowledge regarding the evidence for thermal therapy in LUTD and to set research priorities for the future. METHODS: Literature review based on the search terms: "laser," "radiofrequency," "genitourinary syndrome of the menopause" or "urogenital atrophy," "stress urinary incontinence (SUI)," "pelvic organ prolapse," "OAB" or "overactive bladder," and "urinary tract infection." RESULTS: The current available evidence, though of low or very low quality, appears promising for the use of laser therapy in the management of genitourinary syndrome of the menopause, there are some data to suggest a possible role in SUI although very little evidence for urogenital prolapse. At present, the evidence supporting the use of laser in OAB and recurrent urinary tract infection is limited or lacking, while the available evidence for RF in the management of all forms of LUTD is much less robust. CONCLUSIONS: Laser and RF are being introduced clinically as a minimally invasive, low-risk interventions for women with LUTD although at present, the evidence supporting usage is limited. Consequently, there is an urgent need to demonstrate the safety and efficacy with prospective long-term studies including sham studies and comparative studies with current standard therapy.

Can we replace the catheter when evaluating urinary residuals?

AIMS: To test the different formulae to calculate the bladder volume using ultrasound; the accuracy of patients hearing/feeling "bubbles" at the end of urodynamics testing as a measure of being empty; and how good we are at estimating PVR using X-ray at the end of video urodynamics testing. METHODS: This was a prospective cohort study. Using Sonosite 180 plus, bladder volumes were calculated as, height × width × depth × proportionality constant (0.52, 0.625, 0.65, and 0.7) Patients were asked whether the patient heard or felt "bubbles" at the end of the investigation. Each patient was fluoroscopically screened and the clinician estimated the volume and compared with single-use catheter volume. RESULTS: A total of 85 patients were assessed. All four formulae were significantly correlated. The PC, 0.52, correlated best (r = 0.938, P < 0.001) with no significant difference with the actual volumes ( P = 0.275). The "bubbles test" had a positive predictive value of 93%. A video postvoid residual (PVR) estimation significantly correlated with catheterised bladder volume ( r = 0.842, P < 0.001). There was no significant difference between the estimated and actual bladder volumes ( P = 0.579). CONCLUSION: This study showed that although all four formulae correlated significantly, the PC of 0.52 was the only formula without a significant difference from the actual volume. More work is needed to produce patient individualised PC. Our clinicians were able to accurately estimate the PVR on X-ray. This study has identified the best formula to accurately estimate bladder volume and that video estimation along with the "bubbles" test can avoid unnecessary intervention.

Do we need better information to advise women with stress incontinence on their choice of surgery? Report from the ICI-RS 2018.

AIMS: The regulatory warnings about the safety of the synthetic midurethral slings (MUS) had a significant effect on how patients and physicians approach surgical management of stress urinary incontinence (SUI). In this changing landscape, the purpose of this research Think Tank (TT) was to provide an update of the current knowledge about the safety and efficacy of SUI surgery, to review patient goals and expectations and to identify factors affecting the decision making for surgery. METHODS: This is a consensus report of the proceedings of TT3: "Do we need better information to advise women with stress incontinence on their choice of surgery?" from the annual International Consultation on Incontinence-Research Society (ICI-RS), June 2018. RESULTS: Despite the body of evidence supporting the continued use of MUS, the short follow-up of most of the studies and the lack of "real life" data regarding pain and sexual dysfunction make the development of recommendations challenging. Women with SUI are often happy to "trade" efficacy for a procedure with less associated morbidity and therefore it is not always the procedure with the highest success rate that is ultimately chosen. However, a number of factors influence treatment decision and there is limited evidence about what level of all these factors women are willing to tolerate for a given success rate, or how much success they are willing to trade for a lower complication rate. CONCLUSIONS: The ICI-RS proposed research questions which may be able to assist in improving the counseling and management of women with SUI.

Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study.

AIMS: SYNERGY II was a 12-month phase III trial in patients with overactive bladder (OAB) symptoms that investigated the safety and efficacy of the combination of mirabegron and solifenacin in comparison with each monotherapy. This analysis evaluated the trial findings using four age subgroups (<65, ≥65, <75, and ≥75 years). METHODS: Eligible patients were ≥18 years with symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for ≥3 months. Patients were randomized to receive once-daily solifenacin succinate and mirabegron (5 mg/50 mg; combination), solifenacin succinate, or mirabegron (4:1:1). Safety evaluations: treatment-emergent adverse events (TEAEs), vital signs, and electrocardiogram, post-void residual volume, and laboratory assessments. Primary efficacy variables: change from baseline to end of treatment in number of incontinence episodes/24 h and micturitions/24 h. RESULTS: Of 1794 patients (full analysis set), 614 (34.2%) and 168 (9.4%) were ≥65 and ≥75 years old, respectively. Overall, 856 (47.2%) patients experienced ≥1 TEAE. Higher TEAE incidences were typically observed for the combination versus both monotherapies (eg, constipation) and in the older versus younger age groups (eg, urinary tract infection). Increases in mean pulse rate from baseline of >1 bpm were noted in the combination and mirabegron younger age groups only. No clinically significant findings were observed in the other safety parameters. The efficacy variables improved with all treatments and the greatest improvements were typically observed with combination therapy. CONCLUSIONS: Mirabegron and solifenacin combination therapy was a well-tolerated and effective treatment for patients with OAB symptoms irrespective of their age.

Is our current understanding and management of nocturia allowing improved care? International Consultation on Incontinence-Research Society 2018.

AIMS: Nocturia or waking at night, to urinate is a common cause of awakenings and may lead to sleep disturbance, impaired somatic health, impaired quality of life, and increased mortality. The aim of this report is to point out and discuss the aspects and issues that need to be addressed to improve the care of nocturia. METHODS: This paper is a report of the presentations and subsequent discussion of a Think Tank session at the annual International Consultation on Incontinence-Research Society (ICI-RS) in June 2018 in Bristol. RESULTS AND CONCLUSION: Nocturia is a known risk factor for in-hospital falls. Unfortunately, its assessment in acutely hospitalized (older) people is not the current practice and ward-based care plans are not tailored to this symptom. A new care pathway for hospitalized patients who have nocturia should be considered. More research into the relation of cardiovascular disorders and nocturnal polyuria (NP) is warranted and management of NP patients may be improved by involving a cardiologist in their management. There is definitely a need for phenotyping nocturia in relation to bladder capacity, filling phase, and emptying phase symptoms and how to treat the different phenotypes. In the near future, smart automated monitoring devices and applications might help us to diagnose and treat nocturia with less efforts.

Narrated video demonstrating the procedure of videourodynamics.

AIMS: To present a narrated video designed to demonstrate the steps involved in the procedure of videourodynamics. METHODS: The technique shown and described in this teaching video is that performed in the urogynaecology Department at King's College Hospital, London. The equipment utilizes fluid filled lines and external pressure transducers which provide accurate and consistent results. RESULTS: The advantage of videocystourolodraphy is that as well as incorporating screening fluoroscopy with a cystometric trace, simultaneous assessment of lower urinary tract anatomy and morphology and function is possible. CONCLUSION: Videourodynamics or videocystourogrpahy is a diagnostic tool that incorporates urodynamics with imaging of the lower urinary tract which occurs simultaneously. Thus both functional anatomy and physiology can be assessed.

Does assessing urethral function allow the selection of the optimal therapy for recurrent SUI? Report from the ICI-RS 2017.

AIMS: The management of recurrent stress urinary incontinence following failed previous continence surgery remains challenging. Whilst the role of urodynamic investigations has been questioned in the management of primary stress incontinence there is a widely held view that women with recurrent symptoms require further investigation although there is no agreement regarding which tests are required. We sought to understand what testing is recommended prior to managing this difficult cohort of patients. METHOD: This research proposal was presented at the International Consultation on Incontinence Research Society (ICI-RS) in order to clarify our current knowledge regarding the assessment of urethral function and to set research priorities for the future. RESULTS: Whilst the majority of clinicians would advocate urodynamic evaluation of women with recurrent stress incontinence following previous surgery there is no consensus of opinion as to which tests should be performed, on whom or where. The available evidence to date suggests that urethral function tests do have a role with regard to prognosis following surgery and also in planning the most appropriate surgical intervention. CONCLUSION: The ICI-RS developed a list of research questions which may be able to assist in improving the investigation and management of women with recurrent SUI. Questions included whether patients felt the information gained via urethral function tests had an important role in their counseling regarding outcome of repeat SUI surgery.

Laparoscopic mesh repair of a labial hernia.

AIMS: To present a narrated video designed to demonstrate the steps involved in a laparoscopic mesh repair of a labial hernia. METHODS: This was in a 76-year-old woman who presented with a small bowel hernia in to her left labium majus. In 2014 she had a robotically assisted radical cystectomy for bladder cancer with anterior exenteration. She developed the hernia in February 2015 and initially a vaginal approach was attempted to repair the hernia (with layered non-absorbable sutures to close the fascia over the defect) at her local hospital, although this was unsuccessful. A laparoscopic repair with mesh on the 10 May 2016 was undertaken at our unit. RESULTS: This was a complex case requiring a multi disciplinary approach and individualised care. The need for a mesh was obvious: however, the use of both synthetic and biological meshes to achieve an optimum result was unique and highly successful. CONCLUSION: In this instance a minimally invasive laparoscopic approach where initial adhesiolysis was performed and then a synthetic mesh sandwiched in between two biological porcine meshes provided a unique management solution. The patient was seen 8 weeks post operatively and at 14 months after the procedure. She had complete resolution of her symptoms with no residual hernia.

Patient-reported outcomes from SYNERGY, a randomized, double-blind, multicenter study evaluating combinations of mirabegron and solifenacin compared with monotherapy and placebo in OAB patients.

AIMS: To evaluate patient-reported outcomes (PROs) of combinations of solifenacin and mirabegron compared with solifenacin and mirabegron monotherapy and with placebo in patients with overactive bladder (OAB) from the SYNERGY trial. METHODS: Following a 4-week placebo run-in, period patients (≥18 years) with OAB were randomized 2:2:1:1:1:1 to receive solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg + mirabegron 50 mg, (combination 5 + 50 mg), solifenacin 5 mg, mirabegron 25 mg, mirabegron 50 mg or placebo for 12 weeks, followed by a 2-week washout period. At each visit, PROs related to quality of life, symptom bother, and treatment satisfaction were assessed, including OAB-q Symptom Bother score, health-related quality of life (HRQOL) Total score, treatment satisfaction-visual analogue scale (TS-VAS), and patient perception of bladder condition (PPBC) questionnaires. RESULTS: Overall, 3527 patients were randomized into the study, with 3494 receiving double-blind treatment. At end of treatment (EoT), both combination groups showed greater improvements in OAB-q Symptom Bother score compared with the monotherapy groups (nominal P < 0.001). Statistically significant improvements in HRQOL Total scores were observed in the combination groups versus monotherapy groups (P ≤ 0.002). For both combination groups, the OAB-q Symptom Bother score responder rates at EoT were statistically significantly higher versus mirabegron monotherapy (P < 0.05). The mean adjusted changes from baseline to EoT for PPBC were greater in the combination groups compared with monotherapy groups. CONCLUSIONS: PROs showed that combination therapy provided clear improvements and an additive effect for many HRQOL parameters, including OAB-q Symptom Bother score, HRQOL Total score, and PPBC.