Patient experience of pain during vaginal pessary removal and insertion: a service evaluation study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common problem affecting women, but there is currently a lack of research focusing on patient experience of pessary changes. This study was aimed at capturing the patient perspective of pessary changes and formally assessing pain during pessary removal and insertion. METHODS: A service evaluation request was granted by South Tees Hospitals NHS Trust. Patients undergoing pessary change (ring, shelf, or Gellhorn) in gynaecology outpatient clinics over a 6-month period were asked to rate their pain scores on a ten-point numerical pain-rating scale. Other associated data were collected. RESULTS: Out of 213 women, 58.2% reported that pessary removal was more painful than insertion, 30.5% reported equal pain, and 10.8% reported that insertion was more painful than removal. Pain scores were significantly higher for removal (mean 4.37, median 4, IQR 4-7) than for insertion (mean 2.66, median 2, IQR 2-4, p <0.001). Ring pessaries were significantly less painful to both remove and insert than shelf and Gellhorn pessaries. Smaller pessaries were more painful to both remove and insert. There was no significant difference in pain scores reported by those with or without diagnosed vulval conditions. CONCLUSIONS: Pessary removal causes most women moderate pain, which should be communicated to patients beforehand. Ring pessaries are significantly less painful to change than other pessary types. Clinicians should consider pain as a factor in their decision-making surrounding pessary choice and when counselling patients. Future research should focus on ways to reduce pain during pessary removal.

Impact of intravesical onabotulinumtoxinA (Botox) on sexual function in patients with overactive bladder syndrome: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The association between overactive bladder (OAB) syndrome and sexual dysfunction is well documented. Intra-detrusor onabotulinumtoxinA (Botox) has proven to be effective treatment for OAB syndrome. Our aim was to examine the impact of intravesical Botox injection on sexual function in patients with OAB, by systematically reviewing the literature. METHODS: We reviewed the literature for studies that reported a change in sexual function after Botox treatment in patients suffering from OAB. This review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement using pre-agreed keywords, from database inception to December 2020. Statistical analyses were performed using Review Manager (RevMan; v.5.4). RESULTS: Initial results yielded 455 citations. Seven articles met our inclusion criteria. One article was double-reported, leaving 6 studies in the systematic review. Three observational before-and-after studies used the Female Sexual Function Index (FSFI) with sufficient information, and therefore were included in our meta-analysis. The pooled number of participants in all studies was 119 patients. In the meta-analysis, there was significant improvement in the following domains of the FSFI after Botox injection; desire (mean difference (MD) -0.51, p = 0.02), arousal (MD -0.86, p = 0.02), lubrication (MD -0.57, p = 0.03), orgasm (MD -0.65, p = 0.0003) and satisfaction (MD -0.46, p = 0.05). Pain was the only domain that did not show improvement (MD -0.07, p = 0.79). The total FSFI score was reported in 88 patients (two studies) showing significant improvement (MD -0.77, p = 0.006). CONCLUSIONS: We report a systematic review of the effect of Botox treatment on sexual function in patients with OAB. Although studies are small, the results indicate a positive effect in patients with OAB.

Prevalence of histological abnormalities in hysterectomy specimens performed for prolapse. A systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The practice of histopathological assessment of the uterus following hysterectomy for benign indications including pelvic organ prolapse (POP) surgery is common and often routine. While pathology is not anticipated, the finding of pathology requiring further action is always a concern, in particular CIN (cervical intraepithelial neoplasia) or cervical/uterine malignancy. We aimed to perform a systematic review to understand the prevalence of actionable uterine and cervical pathology in hysterectomy specimens performed for POP. METHODS: A literature search was performed in January 2020 of MEDLINE, Embase and CINAHL using the Healthcare Databases Advanced Search platform. Included studies reported CIN and/or uterine/cervical malignancy in histological assessment of hysterectomy specimens performed purely for POP. Meta-analysis of prevalence was performed using the MetaXL ( www.epigear.com ) add-in for Microsoft Excel. RESULTS: Six hundred seventy-seven records were identified, out of which 34 studies were eligible. Overall prevalence (95% confidence interval [CI]) of endometrial cancer in 33 studies was 0.004 (0.003-0.006), I2 = 41%, number needed to treat (NNT) 1:250. Total actionable uterine pathology was 0.005 (0.003-0.006) in 33 studies, I2 = 35%, NNT = 1:200. Overall prevalence of cervical cancer in 19 papers was 0.001 (0.000-0.002), I2 = 18%, NNT = 1:1000. In 16 studies the overall prevalence of CIN was 0.013 (0.001-0.033), I2 = 95%, NNT = 1:77. Prevalence of total actionable pathology was 0.013 (0.006-0.0023), I2 = 86%, NNT = 1:77. CONCLUSION: The risk of actionable pathology is low, but not negligible. The variation between populations is wide. The prevalence of finding such pathology supports the routine practice of sending all hysterectomy specimens performed for POP for histological assessment.

The effect of advisory documents on mid-urethral sling case acquisition to the British Society Urogynaecology (BSUG) database in England.

INTRODUCTION AND HYPOTHESIS: Many advisory documents have recommended uploading of all mid-urethral sling (MUS) cases onto the British Society of Urogynaecology (BSUG) or British Association of Urological Surgeons (BAUS) database. The aim of this study was to determine whether these documents have resulted in an increase in database case acquisition for MUS surgery. METHOD: We determined the number of cases uploaded onto the BSUG and BAUS databases and cases acquired by Hospital Episode Statistics (HES) over the period January 2011-March 2017 for the 6 months prior to each document and 6 months afterwards. RESULTS: There was an upsurge in data acquisition in 2013, which then declined after year end. There was a significant upsurge in case acquisition associated with the following documents: NHS Medical Director letter (p < 0.00001), the Healthcare Quality Improvement Partnership (HQIP) audit (p < 0.00001). There was a significant drop in case acquisition following the end of the HQIP audit (p < 0.00001) and the Mesh Working Group Interim report (p = 0.00325). CONCLUSION: There was a significant increase in case acquisition with the HQIP audit and decline after it. The significant increase in case acquisition seen after the NHS MD letter in November 2012 may have been due to an overlap in the data capture between it and the HQIP audit. The levels of case acquisition do not compare to registries that are essentially compulsory and therefore we believe that voluntary databases are not effective for device post-market surveillance.

Episcissors-60™ and obstetrics anal sphincter injury: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The National Health Service (NHS) in England has chosen the Episcissors-60™ as one of the products included in the NHS Innovation Accelerator programme. However, the evidence for its effectiveness is scanty. We therefore set out to systematically review the literature to compare risk of obstetric anal sphincter injury (OASI) in women who had undergone episiotomy with Episcissors-60™ versus those who had an episiotomy with other scissors. METHODS: Electronic search was performed on the Healthcare Databases Advanced Search (HDAS) platform using the MEDLINE, EMBASE and CINHAL search engines up to September 2018. The search words used were 'Episcissors-60' or 'episcissors 60.' Studies were included if patients who had episiotomies with Episcissors-60™ were compared with parallel or historic patients who had episiotomy with other scissors. The only restriction used was "human" studies. RESULTS: Of the initial 21 citations, 4 studies had enough information to be included in the meta-analysis. The number of study participants ranged from 63 to 4314. When comparing 797 patients who had episiotomies with Episcissors-60™ to 1122 patients who had episiotomies with other scissors, there was a significant reduction in OASI: risk difference = -0.04 (95% CI = -0.07 to -0.01; p = 0.005, I2 = 41%). The number needed to treat was 25 (95% CI = 14-100). This was not associated with an increase in episiotomy rate. CONCLUSIONS: We reported the first systematic review on the effect of Episcissors-60™ on OASI rate. Although the studies are few, and of small size and low quality, the results are promising in terms of possible reduction in OASI.

Outcome of surgical management for midurethral sling complications: a multicentre retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: Suspension of midurethral sling (MUS) surgery in the UK has led to a call for further evidence regarding long-term morbidity and the efficacy of treatments when mesh complications are encountered. We reviewed how many patients who underwent MUS surgery in Teesside, UK, returned to theatre due to a complication and what the outcomes were following this surgical intervention. METHODS: All patients coded to have undergone an MUS procedure between 1 January 2010 and 31 December 2014 in Teesside were reviewed retrospectively (n = 924). Case notes were analysed for patients who returned to theatre up until December 2017 due to complications related to their original MUS. RESULTS: Seventy-one of 924 (7.7%) women returned to theatre for some form of surgical intervention. There was a statistically significant difference in return-to-theatre rate between the transobturator and retropubic approach groups (63/661; 9.5%; confidence interval (CI) 7.3-11.8% v 8/263; 3.0%; CI 0.96%, 5.1%, odds ratio (OR) 3.35, p = 0.001); 2.8% (26/924) underwent shortening, reburying, incision or MUS excision; 1.0% (9/924) underwent steroid injection along the MUS tract; 1.7% (16/924) underwent surgical treatment of detrusor overactivity; 3.0% (28/924) required further stress incontinence surgery. The risk of unresolved chronic pain post-MUS surgery following treatment of complications was 0.2% (2/924). CONCLUSIONS: Our results show a reassuringly low rate of mesh removal following MUS surgery. Furthermore, outcomes were good following surgical management of MUS complications. We advocate compulsory registration of all MUS procedures, follow-up data and complications to provide robust long-term evidence for the future.

The effect of percutaneous tibial nerve stimulation (PTNS) on sexual function: a systematic review and meta-analysis.

INTRODUCTION: Percutaneous tibial nerve stimulation (PTNS) is now an established treatment of pelvic floor dysfunction such as overactive bladder, faecal incontinence or voiding dysfunction. Prevalence of female sexual dysfunction is high in this group. We aim to examine the effect of PTNS on sexual function in this patient group by systematically reviewing the literature and pooling the data in a meta-analysis. METHODS: The literature search was conducted using the MEDLINE, Embase and CINAHL databases. Initial results yielded 74 citations. From these, nine articles met our inclusion criteria. Two articles were doubly reported, leaving seven studies in the systematic review. Only four studies reported sufficient information to be included in our meta-analysis. RESULTS: Three studies were randomised controlled trials, and five were before-after studies. The number of participants in each study ranged from 11 to 220. Four out of seven studies reported a positive effect of PTNS on sexual function. In the meta-analysis of four studies there was a significant improvement in general sexual function with PTNS (p = 0.04, SMD -0.41, CI[-0.79, -0.03], I2 = 0%). In a subgroup analysis of the bowel domain of sexual function, there was a significant improvement with PTNS (p = 0.03, MD 17.7, CI [1.92, 33.47], I2 = 0%). CONCLUSION: We report a systematic review on the effect of PTNS on sexual function. Although the studies are of small size, the results are promising in terms of a positive effect of PTNS on sexual function, and we recommend further research in this area.

Sacral neuromodulation and sexual function: a systematic review and meta-analysis of the literature.

INTRODUCTION AND HYPOTHESIS: Sexual function is being increasingly recognized as an important patient-reported outcome. Sacral neuromodulation (SNM) is a treatment with an expanding list of indications. The effect of sacral neuromodulation on sexual function has been examined in a number of studies with variable results. In this review, we aim to systematically review the literature and pool the data if appropriate. METHODS: The literature search was conducted primarily on the Healthcare Databases Advanced Search (HDAS) platform using the Medline, EMBASE and CINHAL search engines. Of 196 initial citations, 17 articles met our predefined inclusion criteria. Thirteen studies reported enough information to be included in our meta-analysis. RevMan5 software was used for analysis. RESULTS: Eight of 17 studies reported a positive effect of SNM on sexual function. Pooled analysis of data from 11 studies involving 573 patients before SNM and 438 patients after SNM showed significant improvement in sexual function (SMD = -0.39; 95% CI: -0.58 to -0.19; p = 0.0001). The results remained significant in most subgroup analyses except in patients suffering from fecal incontinence. CONCLUSIONS: SNM in women with pelvic floor disorders, especially bladder dysfunction, seems to have a positive effect on sexual function. This needs to be verified in adequately powered primary research using sexual function as the primary outcome.

One normal void and residual following MUS surgery is all that is necessary in most patients.

INTRODUCTION AND HYPOTHESIS: There is considerable variation worldwide on how the assessment of voiding function is performed following midurethral sling (MUS) surgery. There is potentially a financial cost, and reduction in efficiency when patient discharge is delayed. Using our current practice of two normal void and residual (V&R) readings before discharge, the aim of this retrospective study was to evaluate the likelihood of an abnormal second V&R test if the first V&R test was normal in order to determine if a policy of discharge after only one satisfactory V&R test is reasonable. METHODS: Data from 400 patients who had had MUS surgery with or without other procedures were collected. Our unit protocol included two consecutive voids of greater than 200 ml with residuals less than 150 ml before discharge. The patients were divided into the following groups: MUS only, MUS plus anterior colporrhaphy (AR) plus any other procedures (MUS/AR), and MUS with any non-AR procedures (MUS+). RESULTS: Complete datasets were available for 335 patients. Once inadequate tests (low volume voids <200 ml) had been excluded (28% overall), the likelihood of an abnormal second V&R test if the first test was normal was 7.1% overall, but 3.6% for MUS, 11.5% for MUS/AR and 8.6% for MUS+. CONCLUSION: The findings in the MUS-only group indicate that it is probably safe to discharge patients after one satisfactory V&R test, as long as safety measures such as 'open access' are available so that patients have unhindered readmission if problems arise.

Martius graft for TOT extrusion: a case series.

INTRODUCTION: The management of mid-urethral tape extrusion is inconsistent. We believe that we present here the first case series detailing the use of the Martius graft for trans-obturator tape (TOT) extrusion. METHODS: Five women had a Martius graft for TOT extrusion. Data were obtained retrospectively from case notes and a review postoperatively to investigate the results in the short and intermediate term. RESULTS: All extrusions were greater than 1 cm in diameter and situated between the midline and the lateral vaginal sulcus. In 3 women the tape extrusion was discovered at 6-12 weeks postoperatively and 2 presented with symptoms again after 12 months. Following the Martius graft, there was no ipsilateral recurrence of tape extrusion or exposure. Postoperatively, 2 women received oral antibiotics. Two women developed de novo sexual problems, which had resolved at follow-up. CONCLUSIONS: It is promising that all the tape extrusions were successfully treated with a Martius Graft, thus preserving tape function. There was a high incidence of minor complications initially, but there was minimal long-term morbidity and no cosmetic dissatisfaction. We believe that testing this proposition in a larger case series will provide better evidence.

Give It Up For Baby: outcomes and factors influencing uptake of a pilot smoking cessation incentive scheme for pregnant women.

BACKGROUND: The use of incentives to promote smoking cessation is a promising technique for increasing the effectiveness of interventions. This study evaluated the smoking cessation outcomes and factors associated with success for pregnant smokers who registered with a pilot incentivised smoking cessation scheme in a Scottish health board area (NHS Tayside). METHODS: All pregnant smokers who engaged with the scheme between March 2007 and December 2009 were included in the outcome evaluation which used routinely collected data. Data utilised included: the Scottish National Smoking Cessation Dataset; weekly and periodic carbon monoxide (CO) breath tests; status of smoking cessation quit attempts; and amount of incentive paid. Process evaluation incorporated in-depth interviews with a cross-sectional sample of service users, stratified according to level of engagement. RESULTS: Quit rates for those registering with Give It Up For Baby were 54% at 4 weeks, 32% at 12 weeks and 17% at 3 months post partum (all data validated by CO breath test). Among the population of women identified as smoking at first booking over a one year period, 20.1% engaged with Give It Up For Baby, with 7.8% of pregnant smokers quit at 4 weeks. Pregnant smokers from more affluent areas were more successful with their quit attempt. The process evaluation indicates financial incentives can encourage attendance at routine advisory sessions where they are seen to form part of a wider reward structure, but work less well with those on lowest incomes who demonstrate high reliance on the financial reward. CONCLUSIONS: Uptake of Give It Up For Baby by the target population was higher than for all other health board areas offering specialist or equivalent cessation services in Scotland. Quit successes also compared favorably with other specialist interventions, adding to evidence of the benefits of incentives in this setting. The process evaluation helped to explain variations in retention and quit rates achieved by the scheme.This study describes a series of positive outcomes achieved through the use of incentives to promote smoking cessation amongst pregnant smokers.

Proteolytic activation of the cytotoxic phenotype during human NK cell development.

NK cells induce apoptosis in target cells via the perforin-mediated delivery of granzyme molecules. Cytotoxic human NK cells can be generated by IL-15-mediated differentiation of CD34(+) cells in vitro and these cultures have been used extensively to analyze the development of the NK cell surface phenotype. We have used NK cell differentiation in vitro together with protease-deficient human NK cells to analyze the acquisition of the cytotoxic phenotype. Granzymes are synthesized as inactive zymogens and are proteolytically activated by the cysteine protease cathepsin C. Cathepsin C is also synthesized as a zymogen and activated by proteolysis. We show that human NK cells generated in vitro undergo granule exocytosis and induce the caspase cascade in target cells. IL-15 and stem cell factor (IL-15 plus SCF) induced the expression of the granzyme B and perforin genes and the activation of cathepsin C and granzyme B zymogens. Perforin activation is also mediated by a cysteine protease and IL-15 plus SCF-mediated differentiation was accompanied by perforin processing. However, cathepsin C-deficient human NK cells revealed that perforin processing could occur in the absence of cathepsin C activity. The combination of IL-15 plus SCF is therefore sufficient to coordinate the development of the NK cell surface phenotype with the expression and proteolytic activation of the cytotoxic machinery, reflecting the central role of IL-15 in NK cell development.