ResearchPad - original-clinical-article https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system]]> https://www.researchpad.co/article/elastic_article_7136 Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long‐term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2‐year outcomes.MethodsA total of 51 subjects were implanted with the Axonics System in a single nonstaged procedure. Subjects had OAB, confirmed on a 3‐day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72 hours). Test Responders were defined as subjects that were responders at 1 month postimplant. The efficacy analysis included therapy responder rates, change in the quality of life, and subject satisfaction reported in Test Responders (n = 30) and all implanted subjects (n = 37) that completed the follow‐up visits. Adverse events (AEs) are reported in all implanted subjects.ResultsAt 2 years, 90% of the Test Responders continued to respond to the therapy based on voiding diary criteria. Satisfaction with therapy was reported by 93% of subjects and 86% found their charging experience acceptable. Of the urinary incontinence Test Responders, 88% continued to be responders at 2 years, and 28% were completely dry. There were no unanticipated (AEs) or serious device‐related AEs.ConclusionsThe Axonics System® provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device‐related AEs. Subjects reported continued satisfaction with their therapy. ]]> <![CDATA[Cough stress tests to diagnose stress urinary incontinence in women with pelvic organ prolapse with indication for surgical treatment]]> https://www.researchpad.co/article/N1a288052-617c-4b47-bdb8-ec5096d7d8f0

Abstract

Aims

To evaluate the diagnostic ability of different cough stress tests (CSTs) in women with pelvic organ prolapse (POP), performed during outpatient urogynaecological exams.

Methods

Prospective, multicentre observational study involving women on waiting lists for POP surgery. With a subjectively full bladder, patients were asked to perform five different CSTs: without prolapse reduction ([a] standing, followed by [b] semilithotomy position); keeping semilithotomy position with prolapse reduced (by [c] posterior speculum, followed by [d] pessary); [e] standing again with the pessary in place. Primary outcome was positive CST in at least one of the five CSTs. Bladder volume was measured and symptoms of stress urinary incontinence (SUI) were detected by two validated questionnaires.

Results

A total of 297 women completed all CSTs and were included in the analyses. Mean (SD) age, parity, and body mass index were 64.8 (9.9) years, 2.7 (1.3) deliveries, and 26.6 (3.4) kg/m2, respectively. In total, 99 women (33.3%) reported SUI symptoms. At least one positive CST was recorded in 152 patients (51.1%), and in 90 (59.2%) of these 152, a positive CST was observed only when POP was reduced (occult SUI). The CST was positive in 92 (92.9%) of the 99 patients with coexisting SUI symptoms and in 60 (30.3%) of the 205 asymptomatic patients. The percentage of patients with a positive CST was significantly lower when bladder volume was <200 mL vs ≥200 mL (P = .046).

Conclusions

The identification of urinary leakage cases with CSTs is best achieved using multiple different patient positions, different prolapse reduction methods, and bladder volumes ≥200 mL.

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<![CDATA[Vesomni improves the quality of life in men with lower urinary tract symptoms in routine clinical practice in Europe]]> https://www.researchpad.co/article/N82be2c4e-40c8-426b-affa-8470c52c1a87

Abstract

Aim

To evaluate the impact of Vesomni/Urizia/Volutsa, a fixed‐dose combination tablet containing 6 mg solifenacin (antimuscarinic) and 0.4 mg tamsulosin (α‐blocker), on health‐related quality of life (HRQoL) and treatment satisfaction in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine clinical practice.

Methods

EUROPA was a noninterventional study of men with LUTS/BPH not responding to monotherapy who were prescribed Vesomni in routine clinical practice. Data were collected retrospectively (1 year) and prospectively (1 year). Assessments were performed at baseline, weeks 4 to 8, weeks 9 to 18 (optional), weeks 19 to 39 (optional), and Weeks 40 to 52. The primary endpoint was change from baseline in HRQoL, as assessed by the Overactive Bladder Questionnaire (OAB‐q) symptom bother subscale score. Change from baseline in OAB‐q total and coping, sleep, and social interaction subscale scores, treatment satisfaction‐visual analog scale (TS‐VAS), International Prostate Symptom Score (IPSS), and European Quality of Life 5‐Dimension‐5‐Level (EQ‐5D‐5L) questionnaire were also evaluated.

Results

Five hundred and eighty‐nine patients were enrolled. The mean changes in adjusted mean (95% confidence interval [CI]) OAB‐q symptom bother subscale scores were −16.40 (−24.31, −8.49) at weeks 4 to 8 and −19.59 (−28.26, −10.92) at weeks 40 to 52; at weeks 40 to 52, changes were clinically meaningful in 84.6% of patients. Adjusted mean (95% CI) change from baseline to weeks 40 to 52 were 15.02 (7.35, 22.69), 19.37 (10.86, 27.89), 18.65 (7.44, 29.86), 9.85 (3.90, 15.81), and 16.09 (9.07, 23.11) for concern, coping, sleep, social interaction, and total, respectively. TS‐VAS, IPSS, and EQ‐5D‐5L all improved, and treatment persistence at weeks 40 to 52 was 77.1%. Urinary retention was reported in four (0.7%) patients.

Conclusions

Vesomni was well‐tolerated and improved HRQoL and treatment satisfaction in patients with LUTS/BPH.

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<![CDATA[Abnormal vaginal microbiome associated with vaginal mesh complications]]> https://www.researchpad.co/article/N8a1b5b38-aaf3-4da4-a6c1-c85bdf54e5f7

Abstract

Aims

To identify differences in the vaginal microbiomes of women after transvaginal mesh (TVM) surgery for pelvic organ prolapse with and without mesh‐associated complications.

Methods

Patients with complications were eligible as cases, patients without as controls. DNA was isolated and the V1‐2 region of the 16S ribosomal RNA gene was amplified and sequenced. Overall richness was quantified using Chao1. Overall diversity was expressed as Shannon diversity and screened for group differences using analysis of variance. Multivariate differences among groups were evaluated with functions from R.

Results

We recruited 14 patients after mesh exposure, 5 after contraction, and 21 as controls. The average number of operational taxonomic unit was 74.79 (SD ± 63.91) for controls, 57.13 (SD ± 58.74) after exposures, and 92.42 (SD ± 50.01) after contractions. Total 89.6% of bacteria in controls, 86.4% in previous exposures, and 81.3% in contractions were classified as either Firmicutes, Proteobacteria, or Actinobacteria (P < .001). Veillonella spp. was more abundant in patients after contraction (P = .045). The individual microbiomes varied, and we did not detect any significant differences in richness but a trend towards higher diversity with complications.

Conclusions

The presence of Veillonella spp. could be associated with mesh contraction. Our study did not identify vaginal microbiotic dysbiosis as a factor associated with exposure. Larger cohort studies would be needed to distinguish the vaginal microbiome of women predisposed to mesh‐related complications for targeted phenotyping of patients who could benefit from TVM surgery.

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<![CDATA[Scientific evidence for pelvic floor devices presented at conferences: An overview]]> https://www.researchpad.co/article/Naacac44d-7447-4367-b9eb-f2a26b84cc91

Abstract

Aims

An increasing number of diagnostic and therapeutic medical devices are available to help patients and physicians manage pelvic floor symptoms in women. Many of these are presented at scientific conferences, and in the absence of a gold standard for evaluation, marketing has become more prominent than scientific evaluation. The goal of this study was to (a) provide an overview of pelvic floor devices for women that have been presented at recent annual meetings of leading scientific societies and (b) to summarize and review the scientific evidence underpinning these devices.

Methods

Manual searches were performed of all abstracts presented in 2016 and 2017 at annual meetings of the International Continence Society, the International Urogynecological Association, the European Association of Urology, and the American Urological Association. The exhibition floor of the 2017 International Continence Society was also searched. Subsequently, literature searches of both the MEDLINE and Embase databases were performed in November 2018 to identify original full‐text publications related to the identified devices.

Results

We identified 11 devices from these sources, which were mainly used for the control of urinary incontinence. Only seven of these pelvic floor devices were covered by publications, with no full‐text records identified for the remaining four devices.

Conclusions

Sample sizes were small and there was a lack of convincing evidence for most devices. Despite this, many devices were available in the market. Our findings indicate that the process for introducing these new devices is in stark contrast with the strict requirements for introducing new drug classes.

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<![CDATA[Gonadal shield: is it the Albatross hanging around the neck of developmental dysplasia of the hip research?]]> https://www.researchpad.co/article/5c37bb67d5eed0c484499c2c

Abstract

Purpose

Prospective randomized controlled trials and long-term studies are essential future directions for building ­evidence-based practices in developmental dysplasia of the hip (DDH), however, sufficient attrition in data (> 20%) can introduce bias deteriorating research quality. Pelvic radiography is synonymous with DDH assessment and so are ­Gonadal Shield (GS) recommendations with pelvic radiography. ­Nonetheless, losses to diagnostic information and inadequate protection have been increasingly implicated to GS usage, with significantly worse implications in female patients. Understandably for DDH, a disease with 80% female prevalence, the impact of GS usage on quality of radiographs and readability of radiological data may be drastic. This study aims to objectively define the implications of GS recommendations in DDH patients.

Methods

Pelvis radiographs of all DDH patients under the hip surveillance programme at a tertiary care hospital with a written protocol for GS usage were evaluated. Images were reviewed for gender, GS presence, adequate gonadal protection and obstruction of essential anatomical landmarks for pelvic indices.

Results

In all, 131 pelvis radiographs with DDH diagnoses (age: 1.25 to 6 years; 107 female, 24 male pelvises) were reviewed. Only 42.67% (56) of pelvis radiographs used GS despite the presence of a clear protocol. Useful anatomical landmarks were obstructed in 58.9% of radiographs with GS present. Lost diagnostic information was more common in female patients than male patients (68.1% versus 11.1%, p < 0.01). GS was ineffective at gonadal protection in 73.2% (41) of the pelvises with worse protection in female patients (78.7% vs 44.4%; p = 0.03).

Conclusions

Ironically, essential anatomy was obstructed in all the adequately protected female pelvises. Routine GS usage results in substantial attrition of radiographic data in DDH patients.

Level of Evidence

III

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<![CDATA[Epidemiology of developmental dysplasia of the hip within the UK: refining the risk factors ]]> https://www.researchpad.co/article/5b2a56ad463d7e330b8cec2f

Purpose

The epidemiology and risk factors for developmental dysplasia of the hip (DDH) are still being refined. We investigated the local epidemiology of DDH in order to define incidence, identify risk factors, and refine our policy on selective ultrasound screening.

Methods

With a cohort study design, data were prospectively recorded on all live births in our region from January 1998 to December 2008. We compared data on babies treated for DDH with data for all other children. Crude odds ratios (ORs) were calculated to identify potential risk factors. Logistic regression was then used to control for interactions between variables.

Results

There were 182 children born with DDH (with a total of 245 dysplastic hips) and 37,051 without. The incidence was 4.9 per 1000 live births. Female sex (adjusted OR 7.2, 95% confidence interval [CI] 4.6–11.2), breech presentation (adjusted OR 24.3, 95% CI 13.1–44.9), positive family history (adjusted OR 15.9, 95% CI 11.0–22.9) and first or second pregnancy (adjusted OR 1.8, 95% CI 1.5–2.3) were confirmed as risk factors (p < 0.001). In addition, there was an increased risk with vaginal delivery (adjusted OR 2.7, 1.6–4.5, p < 0.001) and post-maturity (OR 1.7, 1.2–2.4, p < 0.002).

Conclusions

One in 200 children born within our region requires treatment for DDH. Using both established and novel risk factors, we can potentially calculate an individual child’s risk. Our findings may contribute to the debate regarding selective versus universal ultrasound screening.

Level of Evidence

Prognostic Study: Level 1.

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<![CDATA[Does physical therapy prevent post-operative delay in return of function following tension-band plating?]]> https://www.researchpad.co/article/5af54cac463d7e2082fbdec9

Purpose

The clinical outcomes and complications of tension-band plating have been well documented, and commonly include a post-operative delay in return of function. We performed a retrospective comparison study to evaluate the capacity of immediate post-operative physical therapy to prevent this post-operative delay in return of function.

Methods

Sixty-seven consecutive growth-deformity patients who were treated with tension-band plating at a single institution fulfilled the study criteria. Patients were allocated into two treatment groups: no post-operative physical therapy and immediately post-operative physical therapy. All patients were evaluated for delayed return of function, which was defined as use of crutches, lack of >90° flexion and full extension of the knee, or persistent pain requiring medication at the initial 2-week follow-up visit. Rates of delayed function were compared between the two treatment groups.

Results

Among the study participants, 48 patients had no physical therapy and 19 patients had immediate post-operative physical therapy. Eighteen patients in the no physical therapy group reported a delay (37.5 %) while only 2 patients in the physical therapy treatment group reported a delay (10.5 %); p = 0.0386.

Conclusions

Delayed return of function dramatically affects pediatric patients, causing unnecessary absence from school and strain on the caregiver. Therefore, it is important to identify treatment modalities to help mitigate the complications of surgery. We conclude that the use of immediate post-operative physical therapy statistically significantly helps patients to return more rapidly to their functional level.

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