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1.
Surg Endosc ; 37(7): 5215-5225, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-36952046

RESUMEN

BACKGROUND: Robotic surgery has gained popularity for the reconstruction of pelvic floor defects. Nonetheless, there is no evidence that robot-assisted reconstructive surgery is either appropriate or superior to standard laparoscopy for the performance of pelvic floor reconstructive procedures or that it is sustainable. The aim of this project was to address the proper role of robotic pelvic floor reconstructive procedures using expert opinion. METHODS: We set up an international, multidisciplinary group of 26 experts to participate in a Delphi process on robotics as applied to pelvic floor reconstructive surgery. The group comprised urogynecologists, urologists, and colorectal surgeons with long-term experience in the performance of pelvic floor reconstructive procedures and with the use of the robot, who were identified primarily based on peer-reviewed publications. Two rounds of the Delphi process were conducted. The first included 63 statements pertaining to surgeons' characteristics, general questions, indications, surgical technique, and future-oriented questions. A second round including 20 statements was used to reassess those statements where borderline agreement was obtained during the first round. The final step consisted of a face-to-face meeting with all participants to present and discuss the results of the analysis. RESULTS: The 26 experts agreed that robotics is a suitable indication for pelvic floor reconstructive surgery because of the significant technical advantages that it confers relative to standard laparoscopy. Experts considered these advantages particularly important for the execution of complex reconstructive procedures, although the benefits can be found also during less challenging cases. The experts considered the robot safe and effective for pelvic floor reconstruction and generally thought that the additional costs are offset by the increased surgical efficacy. CONCLUSION: Robotics is a suitable choice for pelvic reconstruction, but this Delphi initiative calls for more research to objectively assess the specific settings where robotic surgery would provide the most benefit.


Asunto(s)
Laparoscopía , Procedimientos Quirúrgicos Robotizados , Robótica , Cirugía Plástica , Humanos , Diafragma Pélvico/cirugía , Técnica Delphi , Procedimientos Quirúrgicos Robotizados/métodos , Laparoscopía/métodos
2.
Int Urogynecol J ; 34(9): 2197-2206, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37042972

RESUMEN

INTRODUCTION AND HYPOTHESIS: The purpose was to investigate the safety and feasibility of transurethral injections of autologous muscle precursor cells (MPCs) into the external urinary sphincter (EUS) to treat stress urinary incontinence (SUI) in female patients. METHODS: Prospective and randomised phase I clinical trial. Standardised 1-h pad test, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), urodynamic study, and MRI of the pelvis were performed at baseline and 6 months after treatment. MPCs gained through open muscle biopsy were transported to a GMP facility for processing and cell expansion. The final product was injected into the EUS via a transurethral ultrasound-guided route. Primary outcomes were defined as any adverse events (AEs) during follow-up. Secondary outcomes were functional, questionnaire, and radiological results. RESULTS: Ten female patients with SUI grades I-II were included in the study and 9 received treatment. Out of 8 AEs, 3 (37.5%) were potentially related to treatment and treated conservatively: 1 urinary tract infection healed with antibiotics treatment, 1 dysuria and 1 discomfort at biopsy site. Functional urethral length under stress was 25 mm at baseline compared with 30 mm at 6 months' follow-up (p=0.009). ICIQ-UI-SF scores improved from 7 points at baseline to 4 points at follow-up (p=0.035). MRI of the pelvis revealed no evidence of tumour or necrosis, whereas the diameter of the EUS muscle increased from 1.8 mm at baseline to 1.9 mm at follow-up (p=0.009). CONCLUSION: Transurethral injections of autologous MPCs into the EUS for treatment of SUI in female patients can be regarded as safe and feasible. Only a minimal number of expected and easily treatable AEs were documented.


Asunto(s)
Incontinencia Urinaria de Esfuerzo , Incontinencia Urinaria , Humanos , Femenino , Incontinencia Urinaria de Esfuerzo/terapia , Estudios Prospectivos , Uretra/diagnóstico por imagen , Músculos , Resultado del Tratamiento
3.
Int Urogynecol J ; 33(5): 1243-1250, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35006311

RESUMEN

INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). METHODS: RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. RESULTS: Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman's rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. CONCLUSIONS: Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.


Asunto(s)
Vejiga Urinaria Hiperactiva , Incontinencia Urinaria , Adulto , Femenino , Humanos , Antagonistas Muscarínicos/uso terapéutico , Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/complicaciones , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Incontinencia Urinaria/complicaciones
4.
Int Urogynecol J ; 33(4): 911-918, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34599671

RESUMEN

INTRODUCTION AND HYPOTHESIS: To assess the long-term satisfaction, cure rate and safety of a new titanium-covered transobturator tape compared to polypropylene tape for the treatment of stress urinary incontinence (SUI). METHODS: A prospective study was conducted with 151 patients. Seventy patients underwent transobturator sling surgery with titanium tape from 2011 to 2019, and a historical control group (CG) of 81 patients was treated with a noncoated tape and underwent incontinence surgery from 1999 to 2009. We compared patient-reported outcome measures (PROMs) with the incontinence outcome questionnaire (IOQ). RESULTS: The median follow-up was 2½ years in both groups. Based on responses to the IOQ, a statistically significantly shorter time of recovery (IOQ 15: 21.3 ± 26.4 [TG], 40.2 ± 38.5 [CG], p = 0.02), improvement of sex life (IOQ 13: 34.1 ± 29.4 [TG] vs. 65.3 ± 35.6 [CG], p = 0.01) and less voiding dysfunction (IOQ 19: 30.9 ± 28.1 [CG], 9.3 ± 18.6 [TG], p = 0.01) were observed in the TG. Objectively, no postoperative urinary retention was observed in the TG, but four cases were described in the CG. Ten patients needed a reoperation for SUI in the CG compared to three in the TG (p = 0.03). CONCLUSION: The titanium-covered transobturator sling had superior recovery time, improved sexual function and reduced reoperation rate compared to a historical polypropylene group.


Asunto(s)
Cabestrillo Suburetral , Incontinencia Urinaria de Esfuerzo , Incontinencia Urinaria , Femenino , Humanos , Masculino , Polipropilenos , Estudios Prospectivos , Titanio , Resultado del Tratamiento , Incontinencia Urinaria/cirugía , Incontinencia Urinaria de Esfuerzo/cirugía , Procedimientos Quirúrgicos Urológicos
5.
BJU Int ; 128(5): 586-597, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-33547746

RESUMEN

OBJECTIVES: To better understand the neuropathophysiology of overactive bladder (OAB) in women by characterising supraspinal activity in response to bladder distention and cold stimulation. SUBJECTS/PATIENTS AND METHODS: We recruited 24 female participants, 12 with OAB (median [interquartile range, IQR] age 40 [32-42] years) and 12 healthy controls (HCs) without lower urinary tract (LUT) symptoms (median [IQR] age 34 [28-44] years), and assessed LUT and cognitive function through neuro-urological examination, 3-day bladder diary, urodynamic investigation, and questionnaires. Functional magnetic resonance (MR) imaging using a 3-T scanner was performed in all participants during automated, repetitive bladder filling and draining (block design) with 100 mL body temperature (37 °C) saline using a MR-compatible and MR-synchronised infusion-drainage device until strong desire to void (HIGH-FILLING/DRAINING) and bladder filling with cold saline (4 °C, i.e. COLD). Whole-brain and region-of-interest analyses were conducted using Statistical Parametric Mapping, version 12. RESULTS: Significant between-group differences were found for 3-day bladder diary variables (i.e. voiding frequency/24 h, P < 0.001; voided volume/void, P = 0.04; and urinary incontinence [UI] episodes/24 h, P = 0.007), questionnaire scores (International Consultation on Incontinence Questionnaire-Female LUT symptoms [overall, filling, and UI scores, all P < 0.001]; the Overactive Bladder Questionnaire short form [symptoms and quality-of-life scores, both P < 0.001]; the Hospital Anxiety and Depression Scale [anxiety P = 0.004 and depression P = 0.003 scores]), as well as urodynamic variables (strong desire to void, P = 0.02; maximum cystometric capacity, P = 0.007; and presence of detrusor overactivity, P = 0.002). Age, weight and cognitive function (i.e. Mini-Mental State Examination, P = 1.0) were similar between groups (P > 0.05). In patients with OAB, the HIGH task elicited activity in the superior temporal gyrus, ventrolateral prefrontal cortex (VLPFC), and mid-cingulate cortex; and the COLD task elicited activity in the VLPFC, cerebellum, and basal ganglia. Compared to HCs, patients with OAB showed significantly stronger cerebellar activity during HIGH-FILLING and significantly less activity in the insula and VLPFC during HIGH-DRAINING. CONCLUSIONS: The present findings suggest a sensory processing and modulation deficiency in our OAB group, probably as part of their underlying pathophysiology, as they lacked activity in essential sensory processing areas, such as the insula. Instead, accessory areas, such as the cerebellum, showed significantly stronger activation compared to HCs, presumably supporting pelvic-floor motor activity to prevent UI. The novel findings of the present study provide physiological evidence of the necessity to consider non-bladder aetiologies of bladder symptoms.


Asunto(s)
Encéfalo/diagnóstico por imagen , Encéfalo/fisiopatología , Vejiga Urinaria Hiperactiva/diagnóstico por imagen , Vejiga Urinaria Hiperactiva/etiología , Adulto , Estudios de Casos y Controles , Cognición , Frío , Femenino , Neuroimagen Funcional , Humanos , Imagen por Resonancia Magnética , Pruebas de Estado Mental y Demencia , Solución Salina , Encuestas y Cuestionarios , Vejiga Urinaria/diagnóstico por imagen , Vejiga Urinaria/fisiopatología , Vejiga Urinaria Hiperactiva/fisiopatología , Urodinámica
6.
Neurourol Urodyn ; 40(6): 1402-1413, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-34350610

RESUMEN

AIMS: To systematically evaluate the content and quality of national and international clinical guidelines on pelvic organ prolapse (POP). METHODS: We searched medical databases and organizations websites, to identify national and international guidelines on diagnosis and management of POP. Five authors independently assessed guidelines using the validated AGREE II tool. Its six domains include (1) scope and purpose, (2) stakeholder involvement, (3) rigor of development, (4) clarity of presentation, (5) applicability, and (6) editorial independence. RESULTS: Eight guidelines met the inclusion criteria. Three hundred and thirteen different recommendations were identified. One hundred and ninety-nine recommendations were comparable across guidelines. Thirty-one recommendations were not supported by research evidence. Assessment by history and physical examination using the POP quantification system and consideration of imaging were recommendations featuring in all guidelines. Conservative treatment recommendations namely pelvic floor muscle training and vaginal pessaries were also found in all guidelines. Regarding surgical management, patient counseling, treating only symptomatic POP, consideration of apical fixation during surgical treatment, and use of biological or synthetic implants in recurrent cases were recommendations in all guidelines. Overall, the highest median scores were in the domains "scope and purpose" and "rigor of development". The lowest median score was for applicability (28.3%). Although the median score of "editorial independence" was high (85.4%), variability was also substantial (interquartile range: 12.5-100). CONCLUSION: We identified variations in quality and deficiencies in certain areas, especially "applicability" and "editorial independence." Improvements in these key domains may enhance the quality and clinical impact of clinical practice guidelines.


Asunto(s)
Prolapso de Órgano Pélvico , Guías de Práctica Clínica como Asunto , Femenino , Humanos , Bases de Datos Factuales , Prolapso de Órgano Pélvico/diagnóstico , Prolapso de Órgano Pélvico/terapia
7.
Int Urogynecol J ; 32(7): 1695-1706, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34143238

RESUMEN

INTRODUCTION AND HYPOTHESIS: In evaluating the effectiveness of interventions in perineal trauma research, outcomes reported by patients should have a prominent focus. There is no international consensus regarding the use of either patient-reported outcomes (PROs) or tools used to determine these outcomes (patient-reported outcome measures, PROMs). The objective was to evaluate the selection, reporting and geographical variations of PROs and PROMs in randomised controlled trials (RCTs) on perineal trauma. METHODS: We performed a systematic review of RCTs in perineal trauma research evaluating outcome and outcome measure reporting. We identified PROs and PROMs and grouped PROs into domains and themes, a classification system based on a medical outcome taxonomy. RESULTS: Of 48 included RCTs, 47 reported PROs. In total, we identified 51 PROs. Outcome reporting consistency was low, with 27 PROs reported only once. Nine PROs were reported more than five times, the most frequent being perineal pain, with no geographical variation in reporting. Four themes encompassing 12 domains were identified. The most frequently reported theme was "Clinical", with 25 PROs grouped within four domains. "Resource use" and "Adverse events" themes were rarely reported, with only five PROs. PROMs also exhibited variation. Most common were visual analogue scale (VAS; 100 mm), Cleveland Clinic Continence Score, The Faecal Incontinence Quality of Life scale, VAS (0-10) and the McGill Pain Questionnaire. CONCLUSIONS: Significant heterogeneity in PROs and PROMs was observed among RCTs. Despite inconsistency, PROs are the most prevalent outcome in perineal trauma research. Patient-reported adverse events are underreported. Their use in determining the effectiveness and safety of interventions makes their integration important in perineal trauma core outcome sets. Identification and grouping of outcomes will assist future core outcome consensus studies.


Asunto(s)
Parto , Perineo , Parto Obstétrico , Femenino , Humanos , Evaluación de Resultado en la Atención de Salud , Medición de Resultados Informados por el Paciente , Embarazo
8.
Int Urogynecol J ; 32(11): 2913-2919, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-33830304

RESUMEN

INTRODUCTION AND HYPOTHESIS: Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. METHODS: Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. RESULTS: Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). CONCLUSIONS: Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.


Asunto(s)
Prolapso de Órgano Pélvico , Mallas Quirúrgicas , Humanos , Evaluación de Resultado en la Atención de Salud , Prolapso de Órgano Pélvico/cirugía , Prótesis e Implantes , Resultado del Tratamiento
9.
Skin Pharmacol Physiol ; 34(1): 30-37, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33592607

RESUMEN

BACKGROUND: Chronic vulvar dermatitis (CVD) is the most prevalent disease in gynecologic dermatology. The treatment mainly depends on topical glucocorticoids (TGC) but is challenged by insufficient treatment response. On a histological level, the upregulation of the glucocorticoid receptor ß (GRß), an inhibitor of the active glucocorticoid receptor α (GRα), is discussed as mechanism of glucocorticoid insensitivity. OBJECTIVES: To analyze whether the expression of GRß protein at baseline in keratinocytes may predict responsiveness to TGC in patients with CVD. METHODS: In this retrospective cohort study, clinical and biological data of 25 women with a histological diagnosis of chronic vulvar eczema were analyzed. Randomization was done according to the responsiveness to TGC treatment (responsive vs. nonresponsive). Clinical data and the expression of GRß in the immunohistochemical stained biopsies were examined. RESULTS: Fifty-two percent of women with CVD were nonresponsive to TGC. GRß was abundantly expressed in the cytoplasma of keratinocytes of the vulvar epithelium, but no difference in the level of expression was found among GC responsive and nonresponsive patients in the semiquantitative (p = 0.376) and quantitative analysis (p = 0.894). CONCLUSION: GRß is highly expressed in keratinocytes of the vulvar epidermis affected by CVD, but GRß expression was not increased in patients nonresponsive to TGC compared to responsive patients. Thus, the failure mechanism in nonresponders still remains to be elucidated.


Asunto(s)
Dermatitis/patología , Glucocorticoides/farmacología , Receptores de Glucocorticoides/biosíntesis , Enfermedades de la Vulva/patología , Administración Tópica , Enfermedad Crónica , Femenino , Humanos , Queratinocitos/efectos de los fármacos , Pronóstico , Receptores de Glucocorticoides/antagonistas & inhibidores , Estudios Retrospectivos , Regulación hacia Arriba
10.
Arch Gynecol Obstet ; 303(2): 471-479, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33000294

RESUMEN

PURPOSE: Patients with pelvic floor disorders are growing in number. The aim of this study is to outline the main activities of a urotherapist, an advanced nurse practitioner, in the care of patients with pelvic floor disorders and to evaluate patient satisfaction with the service urotherapists provide. METHODS: The prospective single-center observational study was carried out from July 2016 to June 2018. Parameters used to assess the urotherapist activities included the number of consultations, type of counselling, time frame of consultations and therapy and patient satisfaction. In a subgroup of 38 patients, satisfaction with the urotherapy sessions was evaluated by a questionnaire. RESULTS: Totally, 1709 patients were examined by urogynecologists. Five hundred and fourteen (30%) with chronic pelvic floor disorders were subsequently referred to a urotherapist. Of these patients, 60% were at least 65 years old. The most common pelvic floor disorders (221 patients; 43%) were an overactive bladder, recurrent urinary tract infections, chronic cystitis and pelvic pain syndrome; the second most common pelvic floor disorder was pelvic organ prolapsed (151 patients; 29%). Of the study subgroup comprising 38 patients, 32 (84%) returned the patient satisfaction questionnaire. All 32 patients specified their level of agreement with the urotherapist's professional competence, empathy, temporal availability and quality of advice as "agree to strongly agree." CONCLUSIONS: Management by a urotherapist was highly appreciated. The role of the urotherapist as a care coordinator, their level of autonomy and barriers to the implementation in primary care requires further exploration.


Asunto(s)
Fuerza Muscular/fisiología , Enfermeras Practicantes/psicología , Satisfacción del Paciente/estadística & datos numéricos , Trastornos del Suelo Pélvico/rehabilitación , Incontinencia Urinaria/rehabilitación , Adulto , Enfermería de Práctica Avanzada , Anciano , Conducta Cooperativa , Femenino , Humanos , Relaciones Interprofesionales , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Atención al Paciente , Trastornos del Suelo Pélvico/epidemiología , Prolapso de Órgano Pélvico/epidemiología , Dolor Pélvico/epidemiología , Estudios Prospectivos , Encuestas y Cuestionarios , Vejiga Urinaria Hiperactiva/epidemiología , Infecciones Urinarias/epidemiología
11.
Neurourol Urodyn ; 39(3): 880-889, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-32040864

RESUMEN

AIMS: In the current climate of evidence-based health care, the aim of this meta-synthesis was to collect and systematically analyse data from primary qualitative studies on pelvic organ prolapse (POP), to identify patient-centered perspectives on the natural course of POP. Information acquired in this study may be useful for ongoing research towards the development of core outcome sets (COS) in pelvic floor disorders. METHODS: A CHORUS Working Group performed a standardized search of three different databases (Medline, Embase, Scopus), from inception to October 2019. We selected qualitative studies on women's perspectives on POP that were published in the English language. Three reviewers independently evaluated the quality of eligible papers and highlighted recurrent themes based on patient perspectives. RESULTS: Eighteen qualitative studies including a total of 497 patients were assessed in this analysis. Our study revealed five superordinate themes, recurrently encountered in qualitative studies on POP: awareness of POP (6 studies), communication (9 studies), treatments (10 studies), effects on quality of life (6 studies), and self-image (3 studies). Five out of 10 quality criteria were met by all the studies included, based on an assessment performed using the critical appraisal skills program. CONCLUSIONS: This is the first synthesis of qualitative studies that address POP-related experiences of women, highlighting five superordinate themes, of which treatment was the most commonly reported one. This synthesis' findings may guide quantitative research priorities and will hopefully contribute to the development of a COS for POP.


Asunto(s)
Medición de Resultados Informados por el Paciente , Trastornos del Suelo Pélvico/fisiopatología , Trastornos del Suelo Pélvico/psicología , Prolapso de Órgano Pélvico/fisiopatología , Prolapso de Órgano Pélvico/psicología , Calidad de Vida , Femenino , Humanos , Investigación Cualitativa
12.
BMC Pregnancy Childbirth ; 20(1): 376, 2020 Jun 26.
Artículo en Inglés | MEDLINE | ID: mdl-32591018

RESUMEN

BACKGROUND: More than 85% of women sustain different degrees of trauma during vaginal birth. Randomized controlled trials on childbirth pelvic floor trauma have reported a wide range of outcomes and used different outcome measures. This variation restricts effective data synthesis, impairing the ability of research to inform clinical practice. The development and use of a core outcome set (COS) for childbirth pelvic floor trauma aims to ensure consistent use of outcome measures and reporting of outcomes. METHODS: An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women's Health, including academic community members, researchers, healthcare professionals, policy makers and women with childbirth pelvic floor trauma will lead the development of this COS. Relevant outcome parameters will be identified through comprehensive literature reviews. The selected outcomes will be entered into an international, multi-perspective online Delphi survey. Subsequently and based on the results of the Delphi surveys consensus will be sought on 'core' outcomes. DISCUSSION: Dissemination and implementation of the resulting COS within an international context will be supported and promoted. Embedding the COS for childbirth pelvic floor trauma within future clinical trials, systematic reviews, and clinical practice guidelines is expected to enrich opportunities for comparison of future clinical trials and allow better synthesis of outcomes, and will enhance mother and child care. The infrastructure created by developing a COS for childbirth pelvic floor trauma could be leveraged in other settings, for example, advancing research priorities and clinical practice guideline development.


Asunto(s)
Parto Obstétrico/efectos adversos , Evaluación de Resultado en la Atención de Salud/métodos , Trastornos del Suelo Pélvico/terapia , Proyectos de Investigación , Consenso , Técnica Delphi , Femenino , Humanos , Diafragma Pélvico/lesiones , Embarazo , Participación de los Interesados , Resultado del Tratamiento
13.
Neurourol Urodyn ; 38(2): 509-524, 2019 02.
Artículo en Inglés | MEDLINE | ID: mdl-30431183

RESUMEN

The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life-changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta-analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. AIMS: We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. METHODS: Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. RESULTS: Seventy-one randomized trials were included. Twenty-four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. CONCLUSIONS: Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium- and long-term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues.


Asunto(s)
Ensayos Clínicos como Asunto/normas , Prolapso de Órgano Pélvico/cirugía , Investigación/normas , Mallas Quirúrgicas , Vagina/cirugía , Femenino , Procedimientos Quirúrgicos Ginecológicos/métodos , Humanos , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Resultado del Tratamiento , Prolapso Uterino/cirugía
14.
Int Urogynecol J ; 30(11): 1795-1805, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31073635

RESUMEN

INTRODUCTION AND HYPOTHESIS: Interstitial cystitis (IC) and bladder pain syndrome (BPS) are challenging and encompassing hypersensitivity disorders of the lower urinary tract. A variety of national and international guidelines have been published including guidance on nomenclature, definitions, etiopathology, diagnostics and treatment. A lack of universally established clinical guidance is apparent. The aim of this review is to evaluate key guidelines on this area of practice, identify variations, compare their recommendations and grade them using AGREE II. METHODS: Literature searches were performed using the PUBMED and CINAHL database from January 1, 1983, to December 1, 2018, referring to the search strategy of AUA. Ten national and international guidelines were included into the analysis. We assessed the guidelines with the updated AGREE II. RESULTS: Symptoms congruent in all guidelines are: pain, pressure, discomfort and frequency, urgency and nocturia. Urinalysis is a prerequisite for diagnostics, cystoscopy for most and urodynamics not part of the routine assessment. Treatment options are recommended stepwise. The highest level of evidence and consensus was identified for oral therapies. Nine guidelines had an overall quality score ≥ 50% and three scored ≥ 70% (AUA, GG, RCOG). CONCLUSIONS: The guidelines are congruent in symptom reporting, quite congruent in diagnostics and vary to a high degree on treatment recommendations. The complexity of BPS and emerging evidence indicate the need for regular updating of the guidelines and a wider consensus.


Asunto(s)
Cistitis Intersticial , Cistitis Intersticial/diagnóstico , Cistitis Intersticial/etiología , Cistitis Intersticial/terapia , Humanos , Internacionalidad , Guías de Práctica Clínica como Asunto , Terminología como Asunto
15.
Arch Gynecol Obstet ; 299(4): 993-1000, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30707361

RESUMEN

BACKGROUND: Previous studies using botulinum toxin type A (BT) to treat provoked vestibulodynia (PVD) reported conflicting findings, possibly attributable to singular injections or low doses. We assessed PVD treatment effectiveness with high-dose single injections of BT (50 or 100 units) versus placebo, and then repeat BT 100 U injections over 6 months. METHODS: This was a randomized, double-blind, three-arm, placebo-controlled study with 33 PVD patients. BT 50 U (arm A), 100 U (arm B) or saline (arm C) were injected subcutaneously into the dorsal vulvar vestibulum and pain was assessed after 3 months. The investigation proceeded as an unblinded exploratory analysis, in which symptomatic patients received a BT 100 U injection. Symptomatic patients in arm C received a second BT 100 U injection at the 6-month visit. Symptoms were measured at 3-month cycles using: (1) cotton swab-provoked visual analogue scale (VAS), (2) von Frey filaments, and (3) Marinoff dyspareunia scale. RESULTS: The three groups were comparable in terms of demographics and baseline clinical characteristics. Three months after the initial injection, no significant differences in pain were observed among the study arms, yet significant improvements occurred within all groups using the von Frey filaments test. Results from the exploratory analyses showed repeat injections of 100 U BT over 6 months led to significant pain reduction (VAS and von Frey filaments). Fifty-eight percent (7/12) of patients assessable after repeat injections were symptom-free or had ≥ 2 VAS reduction. Adverse events were minor and no serious adverse events occurred during the RCT or exploratory analysis. CONCLUSIONS: PVD symptoms after one subcutaneous injection of BT (50 or 100 units) did not significantly differ compared to placebo, yet all three study arms experienced a reduction in pain 3 months after a single injection. Exploratory analyses indicated that repeat high-dose BT injections may significantly reduce pain over 6 months. TRIAL REGISTRATION: This trial was registered with the Swiss Medical Agency (reference number: 2007DR2102) in 2007.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Dispareunia/tratamiento farmacológico , Vulvodinia/tratamiento farmacológico , Adulto , Toxinas Botulínicas Tipo A/farmacología , Femenino , Humanos , Masculino , Resultado del Tratamiento , Vulvodinia/patología , Adulto Joven
16.
Ther Umsch ; 73(9): 529-534, 2019.
Artículo en Alemán | MEDLINE | ID: mdl-31113318

RESUMEN

Female pelvic floor: anatomy and normal function Abstract. In the course of evolution, the complex interaction of anatomical structures of the pelvic floor has led to bladder and bowel continence, sexual sensations and reproduction. All these functions and abilities play an important individual and social role, thanks to which higher interactions have become possible. For a better understanding of these functions, underlying anatomical concepts are essential. The knowledge gained through dissection of corpses in earlier centuries is now being expanded through modern imaging techniques and image processing. In the following article, we want to give readers an overview of the anatomically important structures and the functions of the pelvic floor.


Asunto(s)
Diafragma Pélvico , Femenino , Humanos , Diafragma Pélvico/anatomía & histología , Diafragma Pélvico/fisiología
17.
Ther Umsch ; 73(9): 541-546, 2019.
Artículo en Alemán | MEDLINE | ID: mdl-31113319

RESUMEN

Etiology, Diagnosis, and Management of Female Bladder Outlet Obstruction Abstract. Bladder outlet obstruction affects up to every fourth woman. This condition is causing difficulties to void. Patients complain about frequency, an urge to void, or they describe the feeling of post-void residual urine. Increased post-void residual urine or a pathological micturition pattern with increased pressure or pathological flow curves are suggestive for a bladder outlet obstruction. Common causes are genital organ prolapse, previous incontinence surgery, or dysfunctional voiding. Correspondingly, the underlying etiology is determining therapy: surgical correction of the pelvic organ prolapse usually eliminates the obstructive situation; a tightly placed incontinence sling should be loosened or incised, while dysfunctional disorders can be well addressed by pelvic floor rehabilitation.


Asunto(s)
Diafragma Pélvico/fisiopatología , Obstrucción del Cuello de la Vejiga Urinaria , Retención Urinaria , Emociones , Femenino , Humanos , Obstrucción del Cuello de la Vejiga Urinaria/diagnóstico , Obstrucción del Cuello de la Vejiga Urinaria/etiología , Obstrucción del Cuello de la Vejiga Urinaria/terapia , Urodinámica
18.
Neurourol Urodyn ; 36(2): 507-513, 2017 02.
Artículo en Inglés | MEDLINE | ID: mdl-26485226

RESUMEN

AIM: Apical prolapse includes descent of the uterus, vagina cuff, or rarely solely of the cervix. It is estimated that women have an 11-19% life-time risk of undergoing surgery for POP. This rate is projected to increase over the next 2-3 decades. In this FIGO working group report we address the conservative and surgical treatment options for apical prolapse. METHODS: The FIGO working group "Pelvic Floor Medicine and Reconstructive Surgery" describes the different treatments for apical prolapse based on the literature evidence, the cost-effectiveness, the degree of difficulty and summed them up with an experts recommendation. RESULTS: Among the conservative treatment options, pessaries are the most successful options since centuries with a low complication rate and low costs. Among the vaginal operative procedures the sacrospinous ligament fixation (SSLF) and the uterosacral ligament suspension (USLS) show comparable outcomes and efficacy with a different, however, rather low complication pattern and a favorable cost-benefit profile. Sacrocolpopexy, independent on the open abdominal, laparoscopic, or robotic-assisted laparoscopic technique has a good durability and quality of life performance. The minimal invasive techniques are as effective as the open abdominal techniques and there is no difference in mesh exposure. CONCLUSION: Vaginal procedures are well described procedures with favorable outcomes and cost-benefit profiles. Sacral colpopexy has a high-effectivity; data on the route of performance and long-term outcome are awaited. The cost with mesh implants are higher compared to the operations with autologous tissue or any conservative treatment and further studies are recommended to evaluate the cure rates in the span of decades and the possible long-term mesh complications. Neurourol. Urodynam. 36:507-513, 2017. © 2015 Wiley Periodicals, Inc.


Asunto(s)
Procedimientos Quirúrgicos Ginecológicos/métodos , Prolapso de Órgano Pélvico/cirugía , Pesarios , Procedimientos de Cirugía Plástica/métodos , Femenino , Humanos , Laparoscopía/métodos , Calidad de Vida , Mallas Quirúrgicas
19.
Planta Med ; 83(16): 1274-1280, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28437806

RESUMEN

An earlier prospective, randomised, placebo-controlled clinical trial had suggested that Bryophyllum pinnatum might have potential in the treatment of overactive bladder. Here we investigated the effects of B. pinnatum leaf press juice, fractions enriched in flavonoids and bufadienolides, and a flavonoid aglycon mixture and individual aglycons on detrusor contractility as a major target in overactive bladder treatment. The strength of the detrusor contractions was investigated using porcine muscle strips stimulated with KCl. B. pinnatum leaf press juice increased the contraction force of muscle strips. Treatment with the flavonoid-enriched fraction had almost no effect on contractility, while the bufadienolide-enriched fraction and flavonoid aglycons led to a concentration-dependent lowering of the contraction force. The data indicate that several components of B. pinnatum leaf press juice may contribute to the inhibitory effect on detrusor contractility, which in turn provides support to overactive bladder treatment with B. pinnatum.


Asunto(s)
Kalanchoe , Extractos Vegetales/uso terapéutico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Animales , Bufanólidos/uso terapéutico , Femenino , Flavonoides/uso terapéutico , Técnicas In Vitro , Kalanchoe/química , Masculino , Relajación Muscular/efectos de los fármacos , Porcinos
20.
BMC Geriatr ; 17(1): 17, 2017 01 13.
Artículo en Inglés | MEDLINE | ID: mdl-28086759

RESUMEN

BACKGROUND: Specific knowledge of urinary incontinence (UI) and its interrelation with physical and cognitive health is essential to working towards prevention of UI and to improving quality of treatment and care. The purpose of this study was to determine the association between UI and the activities of daily living (ADL) hierarchy scale, the cognitive performance scale (CPS) and comorbid conditions. METHODS: The cross-sectional retrospective analysis of 357 nursing homes in Switzerland was based on data of the Minimum Data Set of the Resident Assessment Instrument 2.0 (RAI-MDS). The analysis examined the effect of ADL hierarchy scale, CPS, joint motion and comorbidities on UI. Women ≥65 years were included (n = 44'811; January 2005 to September 2014) at the time of admission to a nursing home. Statistical analysis was done by means of descriptive statistics and logistic regression analysis. RESULTS: The prevalence of UI was 54.7%, the mean ADL hierarchy scale (± SD) 2.42 ± 3.26 (range = 0-6), the mean CPS 1.95 ± 1.67 (range = 0-6). There was a gradual increase in the odds ratio (OR) for UI depending on the ADL hierarchy scale, from the hierarchy scales of "supervised" to "total dependence" of 1.43 - 30.25. For CPS, the OR for UI from "borderline intact" to "very severe impairment" was 1.35 - 5.99. Considering the interaction between ADL and CPS, all ADL hierarchies remained significantly associated with UI, however for CPS this was the case only in the lower hierarchies. Of the 11 examined comorbid conditions, only diabetes mellitus (OR 1.19), dementia (OR 1.01) and arthrosis/arthritis (OR 1.53) were significantly associated with UI. CONCLUSION: The study indicated that impairment in ADL performance is strongly associated with UI, more than CPS performance and comorbidities. Physical more than cognitive training in order to improve or at least stabilize ADL performance could be a way to prevent or reduce the process of developing UI.


Asunto(s)
Actividades Cotidianas/psicología , Cognición , Hogares para Ancianos , Casas de Salud , Incontinencia Urinaria/epidemiología , Incontinencia Urinaria/psicología , Anciano , Anciano de 80 o más Años , Cognición/fisiología , Estudios Transversales , Demencia/diagnóstico , Demencia/epidemiología , Demencia/psicología , Ejercicio Físico/fisiología , Ejercicio Físico/psicología , Femenino , Humanos , Masculino , Estudios Retrospectivos , Suiza/epidemiología , Incontinencia Urinaria/diagnóstico
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