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.

Healthcare professional's choice for surgical management of stress urinary incontinence in a U.K. tertiary hospital.

OBJECTIVE: In July 2018, NHS England, introduced a pause on vaginal mesh, including the mid-urethral sling (MUS) for treatment of stress urinary incontinence (SUI). NICE guidelines recommend MUS as one of the surgical options for SUI. The aim of our study was to investigate healthcare professionals choices for surgical treatment of SUI, if conservative measures failed. STUDY DESIGN: The urogynaecology department at our tertiary level hospital devised a questionnaire using SurveyMonkey. This was distributed via email to 1058 healthcare professionals of different medical backgrounds. The surgical options were based on the NICE guideline and its patient decision making aid. We also used surgical information from the British society of Urogynaecology (BSUG) and British association of urological surgeons (BAUS). RESULTS: We received 214 responses of which 204 were complete. Twenty six percent of replies were from obstetricians and gynaecologists, 36 % had over 20 years experience and 79 % were female. Forty four percent had no previous knowledge of surgical options. Mid-urethral sling was the most popular choice based on description, success and specific complications. Urethral bulking agent was the only option that increased in popularity after describing complications. Twenty two percent would avoid surgery due to the risk of complications. CONCLUSION: This is the first study evaluating healthcare professionals surgical choice for SUI. Despite negative media publicity and NHS pause on MUS, it was still the most popular choice before and after informing of specific complications. The urethral bulking agent was the only surgical treatment, which increased in popularity after considering complications.

Efficacy and Safety of Combination Pharmacotherapy for Patients with Overactive Bladder: A Rapid Evidence Assessment.

CONTEXT: Oral pharmacotherapy consisting of antimuscarinics, ß3-adrenoreceptor agonists, or combinations of these agents forms the mainstay of overactive bladder (OAB) management. OBJECTIVE: To evaluate the efficacy and safety of combination therapy in patients with OAB. EVIDENCE ACQUISITION: A literature search was conducted in June 2018 using Embase, MEDLINE, and Cochrane databases via Ovid and relevant congress abstracts. Studies reporting the efficacy/safety of two antimuscarinics or a ß3-adrenoreceptor agonist plus an antimuscarinic were included. EVIDENCE SYNTHESIS: Publications reported on clinical efficacy, safety, and health-related quality of life (HRQoL) for mirabegron (M) plus solifenacin (S) from three 12-wk randomised controlled trials (RCTs)-SYMPHONY, SYNERGY, and BESIDE-and a 12-mo RCT, SYNERGY II. SYMPHONY reported statistically significant improvements in clinical symptoms and HRQoL with combination therapy versus solifenacin 5 mg (S5) and placebo. In SYNERGY, there were consistent improvements in urinary incontinence (UI) episodes/24 h and micturitions/24 h (coprimary endpoints), and in secondary efficacy parameters with mirabegron 25 mg (M25) + S5 and mirabegron 50 mg (M50) + S5 versus respective monotherapies. In patients with an inadequate response to S5 monotherapy (BESIDE), greater improvements in UI (primary endpoint) were noted for M50 + S5 versus S5 (p = 0.001). Combination therapy was noninferior to solifenacin 10 mg (S10) for reduction in UI and superior to S10 for improvement in micturition frequency (p < 0.001), and resulted in greater improvements from baseline in OAB-5 Dimension scores versus S5 and S10 (p < 0.01). In SYNERGY II, clinically meaningful and sustained improvements in clinical outcomes were observed for M50 + S5 versus M50 or S5. Combination therapy was well tolerated in all four trials. The incidence of adverse events (AEs) was similar across groups, and there were no notable differences in the incidence of specific AEs. Positive efficacy outcomes were observed in five studies of dual antimuscarinic therapy (trospium + solifenacin). CONCLUSIONS: Mirabegron plus solifenacin provides effective, well-tolerated treatment for patients with OAB. Limited data for dual antimuscarinic therapy suggest a benefit in patients with moderate-to-severe symptoms. PATIENT SUMMARY: Overactive bladder (OAB) is treated with medicines called antimuscarinics, such as solifenacin, propiverine, or trospium, or another ß-adrenoreceptor agonist medicine called mirabegron, which works in a different way. We looked at published scientific studies of patients with OAB treated with mirabegron plus solifenacin together, or with two antimuscarinics. We found that mirabegron plus solifenacin can help reduce symptoms and improve quality of life. Patients tolerate this treatment well, with few patients experiencing side effects.

Assessment of the impact of urogenital prolapse on sexual dysfunction.

Sexual dysfunction is one of the symptoms that motivates women to seek medical help in the management of urogenital prolapse. Conservative or surgical interventions may be offered to treat the prolapse but the question remains as to whether treatment restores sexual function (SF). This article briefly discusses the assessment of SF in women with a urogenital prolapse and reviews the effect of therapeutic interventions on SF.

Digital assessment and quantification of pelvic organ prolapse (DPOP-Q): a randomised cross-over diagnostic agreement trial.

INTRODUCTION: Pelvic Organ Prolapse Quantification (POP-Q) system, measured in centimetres using a ruler (e.g. POPstix®), is recommended to quantify prolapse severity. POPstix® are costly (US $1/ruler). Home-made devices are used instead, but these have not been shown to be reproducible. HYPOTHESIS: Digitally assessed POP-Q (DPOP-Q) is as reliable, reproducible and acceptable as POP-Q assessed using POPstix®. METHODS: In this randomised crossover diagnostic agreement trial, each assessor measured the index finger of their dominant hand using a ruler. At visit one, patients were randomised to either POPstix® POP-Q assessment in a modified lithotomy position or DPOP-Q in both modified a lithotomy and a standing position. After the first clinician conducted this assessment, a second blinded clinician then carried out the remaining assessment on the same patient. For each examination, duration was recorded, along with a patient-completed discomfort score. Twenty-five women were invited for visit two, at which DPOP-Q was recorded by the same clinician who undertook DPOP-Q at the first visit. This allowed evaluation of inter- and intraobserver agreement together with examination acceptability. RESULTS: One hundred and nine women were recruited [median age 55 years, parity 2, body mass index (BMI) 27.1]. Of the 25 patients invited, 23 returned for visit two. DPOP-Q had high interobserver reliability [κ = 0.94, 95 % confidence interval (CI) 0.878-0.996] and intraobserver reliability (α = 0.96) with POPstix®. DPOP-Q was significantly quicker (p = 0.02) and less uncomfortable (p < 0.01) than POPstix® POP-Q. CONCLUSION: DPOP-Q is reliable, acceptable and cost effective.

Defining cure.

This paper is a summary of the presentations made as Proposal 2-"Defining cure" to the 2nd Annual meeting of the ICI-Research Society, in Bristol, 16th June 2010. It reviews definitions of 'cure' and 'outcome', and considers the impact that varying definition may have on prevalence studies and cure rates. The difference between subjective and objective outcomes is considered, and the significance that these different outcomes may have for different stakeholders (e.g. clinicians, patients, carers, industry etc.) is discussed. The development of patient reported outcome measures and patient defined goals is reviewed, and consideration given to the use of composite end-points. A series of proposals are made by authors and discussants as to how currently validated outcomes should be applied, and where our future research activity in this area might be directed.

Is there a discrepancy between patient and physician quality of life assessment?

AIMS: Quality of Life (QoL) assessment remains integral in the investigation of women with lower urinary tract dysfunction. Previous work suggests that physicians tend to underestimate patients' symptoms and the bother that they cause. The aim of this study was to assess the relationship between physician and patient assessed QoL using the Kings Health Questionnaire (KHQ). METHODS: Patients complaining of troublesome lower urinary tract symptoms (LUTS) were recruited from a tertiary referral urodynamic clinic. Prior to their clinic appointment they were sent a KHQ, which was completed before attending. After taking a detailed urogynecological history, a second KHQ was filled in by the physician, blinded to the patient responses, on the basis of their impression of the symptoms elicited during the interview. These data were analyzed by an independent statistician. Concordance between patient and physician assessment for individual questions was assessed using weighted kappa analysis. QoL scores were compared using Wilcoxons signed rank test. RESULTS: Seventy-five patients were recruited over a period of 5 months. Overall, the weighted kappa showed relatively poor concordance between the patient and physician responses; mean kappa: 0.33 (range 0.18-0.57). The physician underestimated QoL score in 4/9 domains by a mean of 5.5% and overestimated QoL score in 5/9 domains by a mean of 6.9%. In particular, physicians underestimated the impact of LUTS on social limitations and emotions (P < 0.05). CONCLUSION: This study confirms that physicians often differ from patients in the assessment of QoL. This is most likely due to a difference in patient-physician perception of "significant" LUTS and clearly demonstrates the importance of patient evaluated QoL in routine clinical assessment.