Cost-Effectiveness of 2 Models of Pessary Care for Pelvic Organ Prolapse: Findings From the TOPSY Randomized Controlled Trial.

OBJECTIVES: Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary self-management (SM) when compared with clinic-based care (CBC). A decision analytic model was developed to extend the economic evaluation. METHODS: A randomized controlled trial with health economic evaluation. The SM group received a 30-minute SM teaching session, information leaflet, 2-week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality-adjusted life year (QALY), 18 months post-randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period. RESULTS: There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20 000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net benefit was estimated as £4221, and the probability of SM being cost-effective at 5 years was 69.7%. CONCLUSIONS: Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.

Women's Experiences of Urinary Tract Infections and Impact on Life: An Exploratory Qualitative Study.

IMPORTANCE: Despite high incidences of urinary tract infections (UTIs), little is known about how bothersome symptoms are and the effects on women's life and sexual activity, leaving a gap in our understanding of the physical and emotional effects of UTIs on women. OBJECTIVES: This initial exploratory and descriptive study analyzes women's experiences of UTI and their perceived impact on quality of life. STUDY DESIGN: Qualitative interviews were undertaken with 23 women who had experienced at least 1 UTI, recruited from different settings-primary care, general gynecology clinics, urogynecology clinics, and online via social media. Data were analyzed thematically. RESULTS: Three themes described women's experiences of UTI: Women in all groups reported a wide range of physical symptoms and described the financial and psychological effects of UTIs. These effects seemed worse in women recruited via social media who also reported experiencing strong emotions and worries about close family members. Urinary tract infection support groups were considered useful, with women being grateful for consultations with alternative health practitioners and presuming safety of natural products. CONCLUSIONS: Having a UTI appeared to affect women in a variety of ways, ranging from having different physical symptoms to being psychologically affected by these symptoms, which affected their quality of life in different ways. This research contributes to the growing evidence on how UTIs affect women, specifically further expanding on the impact on women in a range of settings-in the community and different health care settings.

Use of Magnetic Resonance Imaging in women with suspected complications following insertion of implants for pelvic organ prolapse and stress urinary incontinence surgery.

OBJECTIVE: To evaluate the role of Magnetic Resonance Imaging (MRI) in women presenting with suspected implant complications following surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). STUDY DESIGN: Retrospective single-centre cohort study in a designated tertiary referral centre. All women with vaginally and/or abdominally placed implants for POP or SUI who were referred with suspected mesh complications, and investigated with an MRI scan, between January 2018-October 2020 were included in the study. RESULTS: 97 women were identified over this time-period with a total of 123 implants, a median age of 55 years (Range: 34-79) and an average insertion to presentation time of 84 months (Range: 2-300). 78% (74) had one implant in situ, with the remainder having at least 2 in situ. Transobturator tapes (TVT-O/TOT) were the most common implants [35% (43)]. Chronic Pelvic or abdominal pain was the most common clinical symptom [73.2% (71/112 primary complaints)] with provoked tenderness on examination being the most common clinical finding [27.8% (32/115 clinical findings)]. MRI was more likely to detect abdominally placed implants [100% (all 30)] and Retropubic Tapes [89% (16/18)] when compared to Transvaginal POP implants [87.5% (28/32)] and TVT-O/TOT [67% (29/43)]. MRI identified both cases of Sacrocolpopexy mesh rupture as well as all 11 cases of infection (100%). In 91% (10/11) of these cases, MRI revealed the infection to be more widespread than clinical findings initially suspected. Cohen's Kappa demonstrated excellent correlation between MRI and surgical findings in cases with implant related infection, rupture and normal findings (κ = 1; z = 4.58; p = 0.00000459). CONCLUSION(S): MRI can be a useful tool in assessment and management of patients with complications from implants. MRI can detect infection that may be more extensive that is initially clinically apparent in the outpatient setting. Abdominal implants appear to be easier to detect than transvaginal meshes and trans obturator tapes.

Learning from the report of the independent medicines and medical devices safety review: "first do no harm".

This is a review of the learning points from the Independent Medicines and Medical Devices Safety Review,1 chaired by Baroness Julia Cumberlege CBE DL. This system-wide review was initiated by the then Secretary of State for Health and Social Care, following patient-led campaigns. It looked at how the "healthcare system reacted as a whole, and how that response can be made more robust, speedy and appropriate".We aim to highlight the learning points for doctors in Obstetrics and Gynaecology as these are relevant to our current practice and future changes in our healthcare system. These are: Aims of the review: why it was initiated and how it was conductedOverarching themes and missed opportunities to prevent avoidable harmThree clinical scenarios: their histories, issues and adverse events associated with their use and the current response in Scotland The hormone pregnancy test - PrimodosThe anti-epileptic drug - sodium valproateSurgical mesh for prolapse & incontinenceThe recommendations made by the review and implementation guidanceResponses to the review, such as apologies issued by BSUG2/BAUS3/RCOG,4 and compensations schemes such as the Scottish scheme as recommended by the review.