Patient preferences for disposable and reusable vaginal specula and their willingness to compromise in the era of climate change: A cross-sectional study.

OBJECTIVE: To evaluate patient satisfaction on gynaecological examination with metal, plastic and biobased plastic vaginal specula, and to investigate whether patients are willing to compromise on comfort for a more sustainable healthcare system. DESIGN: Cross-sectional study: population-based survey. SETTING: Gynaecological outpatient clinics in five Dutch hospitals. POPULATION: Patients during general gynaecology consultation hours. METHODS: A survey containing two questions about patient demographics, four about comfort and five about sustainability and healthcare was distributed. MAIN OUTCOME MEASURES: Comfort score (scale 1-10). SECONDARY OUTCOMES: (1) temperature, size and ease of insertion, (2) willingness to compromise for a more sustainable healthcare system. RESULTS: In all, 196 patients completed the survey. Biobased plastic vaginal specula scored significantly higher on comfort than the metal ones (mean 8.03 ± 1.65 versus 7.26 ± 1.51 respectively; P < 0.001). The biobased plastic vaginal speculum is significantly the most comfortable on temperature, whereas the metal speculum is the least comfortable (P < 0.007). Most patients are willing to compromise on comfort or are open to the reuse of disposables to contribute to a more sustainable healthcare. The majority of patients (77%) urge healthcare organisations to combat climate change. CONCLUSIONS: There is a small but statistically significant difference in favour of a biobased plastic speculum regarding comfort score, although it might be questioned whether this is clinically relevant. Furthermore, patients are willing to compromise on comfort for a more sustainable healthcare, which should be a contributing factor in speculum selection.

International urogynecological consultation chapter 4.1: definition of outcomes for pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: This manuscript of Chapter 4 of the International Urogynecological Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature and makes recommendations on the definition of success in the surgical treatment of pelvic organ prolapse. METHODS: An international group containing seven urogynecologists performed an exhaustive search of the literature using two PubMed searches and using PICO methodology. The first search was from 01/01/2012-06/12/2022. A second search from inception to 7/24/2022 was done to access older references. Publications were eliminated if not relevant to the clinical definition of surgical success for the treatment of POP. All abstracts were reviewed for inclusion and any disagreements were adjudicated by majority consensus of the writing group. The resulting list of articles were used to inform a comprehensive review and creation of the definition of success in the surgical treatment of POP. OUTCOMES: The original search yielded 12,161 references of which 45 were used by the writing group. Ultimately, 68 references are included in the manuscript. For research purposes, surgical success should be primarily defined by the absence of bothersome patient bulge symptoms or retreatment for POP and a time frame of at least 12 months follow-up should be used. Secondary outcomes, including anatomic measures of POP and related pelvic floor symptoms, should not contribute to a definition of success or failure. For clinical practice, surgical success should primarily be defined as the absence of bothersome patient bulge symptoms. Surgeons may consider using PASS (patient acceptable symptom state) or patient goal attainment assessments, and patients should be followed for a minimum of at least one encounter at 6-12 weeks post-operatively. For surgeries involving mesh longer-term follow-up is recommended.

Comparing Single-Incision Midurethral Sling with Bulking Agents for Female Stress Urinary Incontinence: Rationale for a Non-Randomized Controlled Trial.

OBJECTIVES: Midurethral slings are considered the gold standard for the surgical treatment of stress urinary incontinence (SUI), with an efficacy up to 80%. Another therapeutic option is the use of bulking agents, which create an artificial mass in the urethral submucosa, with an efficacy varying from 64% to 74%. Although bulking agents have a lower risk of complications than midurethral sling surgery, they are mainly used in case a midurethral sling is not an option or if midurethral sling surgery failed to cure stress urinary incontinence. In this study, we offer all patients with SUI in secondary care a choice between a single-incision midurethral sling procedure and treatment with a bulking agent. We want to examine patient preference and patient satisfaction for both procedures. We expect that offering both interventions in combination with standardized counselling will result in high patient satisfaction. DESIGN: In this non-randomized controlled trial, 266 patients will be objectively counselled for both interventions, after which all patients will choose between single-incision midurethral slings and polyacrylamide hydrogel (PAHG), followed by the standard care procedure for women with SUI. PARTICIPANTS/MATERIALS, SETTING, METHODS: From January 1, 2021, onward, all consecutive adult patients (between 18 and 80 years of age) attending the outpatient gynaecology department with objectively confirmed, moderate to severe SUI will be eligible for enrolment in this non-randomized study. The primary outcome is patient satisfaction at 1 year, measured by the Patient Global Impression of Improvement; secondary outcomes are patient satisfaction at 3 months, objective and subjective cure at 3 months and 1 year, adverse events, post-operative pain, and cost-effectiveness. Differences in outcome measures will be assessed through logistic and linear regression analyses, both unadjusted and adjusted with covariate adjustment using the propensity score. RESULTS: No results are available yet. LIMITATIONS: The major disadvantage of this study design is the potential confounding bias. We intend to eliminate this bias by applying propensity scoring. CONCLUSION: By designing a non-randomized patient preference trial, we not only expect to demonstrate high patient satisfaction with both interventions but also provide insight into the possible role of PAHG-injections in the treatment of female SUI as a first-choice non-conservative treatment.

The efficacy of botulinum toxin a injections in pelvic floor muscles in chronic pelvic pain patients: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: Chronic pelvic pain (CPP) is a common multifactorial condition affecting 6 to 27% of women aged 18-50 years worldwide. This study was conducted to review and meta-analyse the current literature on the reduction of chronic pelvic pain after botulinum toxin A (BTA) injection. METHOD: In July 2021 we performed a systematic search in PubMed and EMBASE to assess the benefits of BTA injection in pelvic floor muscles in women with chronic pelvic pain. Primary outcome was reduction in visual analogue scale (VAS) after treatment. Secondary outcomes evaluated were: reduction of dyspareunia, pelvic floor resting pressure and quality of life. Identified reports were assessed on quality of reporting and risk of bias. Standardized mean difference (SMD) was used to combine and analyse outcomes of the included studies. RESULTS: Eight studies with 289 participants were considered eligible to be included in this systematic review and meta-analysis. After recalculating SMD into VAS scores (0-100), long-term follow-up (24-26 weeks) showed a significant 15-point improvement in VAS scores (95% CI: 8.8-21.5) for non-menstrual pelvic pain and a 13-point improvement (95% CI: 2.1-24.0) for dyspareunia. BTA injection had a significant effect on pelvic floor resting pressure and quality of life. CONCLUSION: There is limited scientific evidence on the effectiveness of BTA injections in pelvic floor muscles in women with chronic pelvic pain. The available studies show that BTA injections significantly reduce pain levels and improve quality of life at 6 months follow-up. PROSPERO ID: CRD42018105204.

Long-term safety, objective and subjective outcomes of laparoscopic sacrocolpopexy without peritoneal closure.

INTRODUCTION AND HYPOTHESIS: The laparoscopic sacrocolpopexy (LSC) is performed to support DeLancey's level I in patients with pelvic organ prolapse (POP). Although several studies have been conducted on the safety, objective and subjective outcomes of LSC, the specific effect of retroperitonealisation of mesh is unknown. This study is aimed at analysing the safety, objective and subjective outcomes of the LSC without peritoneal closure of mesh. METHODS: The patients included have undergone an LSC for POP between 2004 and 2014. Retrospectively, a cohort of n = 178 was identified and asked to participate in a follow-up study. Chart research was performed. When informed consent was obtained, questionnaires were sent and the patients underwent a physical examination, including a POP-Q assessment. Each complication was scored by four reviewers for possibly being related to the non-peritonealisation of mesh. RESULTS: The data on the outcome cohorts were complete for safety n = 178, objective n = 124, and subjective n = 61. The Patient Global Impression of Improvement (PGI-I) score is provided in 106 questionnaires. In this study, 77 complications were observed in 49 different patients. The total success rate (no reoperation, no descent beyond the hymen and no bulging symptoms) is 59.0% with a median follow-up (IQR) of 35 months (18-51). Seventy-six patients (71.7%) described their condition as being (much) improved after LSC. CONCLUSIONS: Three serious complications observed during the 178 LSCs were, by full consensus, thought to be possibly related to the non-peritonealisation of mesh. More than 70% of the patients found their condition to be (much) improved after the procedure.

Longitudinal 3.0T MRI analysis of changes in lymph node volume and apparent diffusion coefficient in an experimental animal model of metastatic and hyperplastic lymph nodes.

PURPOSE: To perform a longitudinal analysis of changes in lymph node volume and apparent diffusion coefficient (ADC) in healthy, metastatic, and hyperplastic lymph nodes. MATERIALS AND METHODS: Three groups of four female Copenhagen rats were studied. Metastasis was induced by injecting cells with a high metastatic potential in their left hind footpad. Reactive nodes were induced by injecting Complete Freund Adjuvant (CFA). Imaging was performed at baseline and at 2, 5, 8, 11, and 14 days after tumor cell injection. Finally, lymph nodes were examined histopathologically. RESULTS: The model was highly efficient in inducing lymphadenopathy: subcutaneous cell or CFA inoculation resulted in ipsilateral metastatic or reactive popliteal lymph nodes in all rats. Metastatic nodal volumes increased exponentially from 5-7 mm(3) at baseline to 25 mm(3) at day 14, while the control node remained 5 mm(3). The hyperplastic nodes showed a rapid volume increase reaching a plateau at day 6. The ADC of metastatic nodes significantly decreased (range 13%-32%), but this decrease was also seen in reactive nodes. CONCLUSION: Metastatic and hyperplastic lymph nodes differed in terms of enlargement patterns and ADC changes. Enlarged reactive or malignant nodes could not be differentiated based on their ADC values.

The influence of the b-value combination on apparent diffusion coefficient based differentiation between malignant and benign tissue in cervical cancer.

PURPOSE: To analyze the influence of different b-value combinations on apparent diffusion coefficient (ADC)-based differentiation of known malignant and benign tissue in cervical cancer patients. MATERIALS AND METHODS: A total of 35 patients with stage IB1, IB2, IIA cervical cancer underwent a 3.0T MRI scan prior to radical hysterectomy and pelvic lymph node dissection. Conventional T1- and T2-weighted sequences and a diffusion-weighted sequence (b = 0, 150, 500, 1000 seconds/mm(2)) were performed. Regions-of-interest (ROI) were drawn on ADC maps derived from five different b-value combinations (0, 500; 0, 150, 500; 0, 1000; 0, 150, 500, 1000; 150, 500, 1000 seconds/mm(2)). The influence of the b-value combination on ADC-based differentiation of benign and malignant tissue was analyzed using receiver-operating-characteristics curves. RESULTS: For all b-value combinations, ADCs were significantly lower (P < 0.001) in cervical malignancies (1.15 +/- 0.21.10(-3); 1.10 +/- 0.21.10(-3); 0.97 +/- 0.18.10(-3); 0.97 +/- 0.23.10(-3) and 0.85 +/- 0.18.10(-3) mm(2)/second respectively to the aforementioned b-value combinations) than in benign cervix (2.08 +/- 0.31.10(-3); 2.00 +/- 0.29.10(-3); 1.62 +/- 0.23.10(-3); 1.54 +/- 0.21.10(-3) and 1.42 +/- 0.22.10(-3) mm(2)/second respectively). The diagnostic accuracy was high for all b-value combinations and without statistical differences between the combinations. CONCLUSION: ADC-based differentiation of benign from malignant cervical tissue is independent of the tested b-value combinations. The results support the inclusion and possible pooling of studies using different b-value combinations in meta-analyses on ADC-based tissue differentiation in cervical cancer.

Observer variation of magnetic resonance imaging and diffusion weighted imaging in pelvic lymph node detection.

AIM: Conventional MRI and the recently developed diffusion weighted imaging (DWI) technique both are being used for the detection of pelvic lymph node metastasis in gynaecologic cancers. Little is known about the reproducibility of DWI. This study assesses the reproducibility of pelvic lymph node detection by conventional MRI and DWI. MATERIALS AND METHODS: 17 patients with gynaecological malignancies eligible for curative surgery were selected as population of interest. They had undergone preoperative conventional MRI and DWI on a 3.0T MR scanner. All images were evaluated by two experienced radiologists. Inter- and intra-observer agreements were assessed, and whether lymph node size and region were related to reproducibility. Differences were tested by Chi-square statistics. RESULTS: The reproducibility ranged between 42% and 65% for the two observers and for the two imaging tests, conventional MRI and DWI. Higher percentages of agreement were found for larger lymph nodes, i.e. for long as well as short axis diameter exceeding 5mm. Also, agreement was better for lymph nodes in the external iliac region and the obturator region compared to detection of lymph nodes in the common iliac area. Results for the newer technique, DWI, were comparable to the results of the more conventional MRI sequences. CONCLUSION: Reproducibility of MRI and DWI in the detection of pelvic lymph nodes in patients with a gynaecological malignancy was similar. For lymph nodes exceeding 5mm in both long and short axis diameter the agreement was considerably better than for smaller nodes.

Detection of lymph node metastases by gadolinium-enhanced magnetic resonance imaging: systematic review and meta-analysis.

BACKGROUND: Gadolinium-based contrast agents are used with magnetic resonance imaging (MRI) to highlight tumor vascularity in organs. They are also widely used for primary tumor visualization. We conducted a systematic review and meta-analysis of the existing evidence of the accuracy of gadolinium-enhanced MRI for staging lymph node metastases. METHODS: We systematically searched the MEDLINE, Cochrane, CANCERLIT, and EMBASE databases for studies published in English or German from January 1, 1988, to January 1, 2008, that assessed the diagnostic accuracy of gadolinium-enhanced MRI in the evaluation of lymphatic metastases compared with histopathologic examination as the reference test. Based on a priori-defined clinical considerations, we studied three subgroups of studies: those that used a single malignancy criterion and those that used multiple malignancy criteria with or without contrast highlighting. Summaries of MRI sensitivity and specificity for detecting lymph node metastases were calculated using a bivariate regression model. All statistical tests were two-sided. RESULTS: The literature search yielded 43 full-text papers that were considered for inclusion in the meta-analysis. We performed quantitative pooled analyses on the 32 studies that provided data on patient-level diagnosis. The weighted estimates of sensitivity and specificity for all studies combined were 0.72 (95% confidence interval [CI] = 0.66 to 0.79) and 0.87 (95% CI = 0.82 to 0.91). Estimates of sensitivity and specificity were essentially unchanged for studies that used a single malignancy criterion (0.71 [95% CI = 0.61 to 0.79] and 0.88 [95% CI = 0.80 to 0.93], respectively; n = 11 studies) or multiple malignancy criteria without contrast enhancement (0.70 [95% CI = 0.58 to 0.79] and 0.86 [95% CI = 0.68 to 0.94], respectively; n = 6 studies). The sensitivity increased to 0.84 (95% CI = 0.70 to 0.92), with a specificity of 0.82 (95% CI = 0.72 to 0.89) for the nine studies that incorporated contrast enhancement in their multiple malignancy criteria. Six studies did not define the malignancy criteria they used. CONCLUSIONS: The overall accuracy of gadolinium-enhanced magnetic resonance imaging for the detection of nodal metastases is moderate. Incorporating contrast enhancement in the malignancy criteria substantially improves the accuracy of this diagnostic test.