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1.
Neurourol Urodyn ; 42(4): 875-885, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36811502

RESUMO

AIMS: Pelvic floor symptoms (PFS), including lower urinary tract symptoms, defecation problems, sexual dysfunction, and pelvic pain, are common in males and females. Comparing pelvic floor musculature (PFM) function between sexes may reveal important differences relevant to clinical care. This study aimed to compare male and female PFM function and to assess the function of both sexes with the number and type of PFS. METHODS: We purposively enrolled males and females aged ≥ 21 years with 0-4 PFS based on questionnaire responses in an observational cohort study. Participants then underwent PFM assessment, and muscle function in the external anal sphincter (EAS) and puborectal muscle (PRM) were compared between sexes. The relationships between muscle function and the number and type of PFS were explored. RESULTS: Of the invited 400 males and 608 females, 199 and 187 underwent PFM assessment, respectively. Compared with females, males more often showed increased EAS and PRM tone during assessments. Compared with males, females more often showed weaker maximum voluntary contraction (MVC) of the EAS and dysfunctional endurance of both muscles; additionally, those with zero or one PFS, sexual dysfunction, and pelvic pain more often showed a weak MVC of the PRM. CONCLUSIONS: Despite a few similarities between males and, females we found differences in muscle tone, MVC, and endurance between male and female PFM function. These findings provide useful insights into the differences in PFM function between males and females.


Assuntos
Distúrbios do Assoalho Pélvico , Disfunções Sexuais Fisiológicas , Feminino , Masculino , Humanos , Diafragma da Pelve , Contração Muscular/fisiologia , Canal Anal , Dor Pélvica
2.
BJOG ; 129(9): 1538-1545, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35460163

RESUMO

OBJECTIVE: To assess the cost-effectiveness of app-based treatment for female stress, urgency or mixed urinary incontinence (UI) compared with care-as-usual in Dutch primary care. DESIGN: A pragmatic, randomised controlled, superiority trial. SETTING: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. POPULATION: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. METHODS: The standalone app included conservative management for UI with motivation aids (e.g. reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. MAIN OUTCOME MEASURES: Costs and cost-effectiveness and -utility were assessed from a societal perspective, based on incontinence impact adjusted life years (IIALYs), quality adjusted life years (QALYs) and medical, non-medical and productivity costs. Information on costs was obtained with the iMCQ and iPCQ questionnaires (medical consumption and productivity cost questionnaires). RESULTS: In all, 262 women were andomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up, respectively. Costs were lower for app-based treatment with € -161 (95% confidence interval [CI -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger incremental cost-effectiveness ratios (ICER: -€3696) and incremental cost-utility ratios (ICUR: €6379). CONCLUSION: App-based treatment is a cost-effective alternative to care-as-usual for women with UI in Dutch primary care. TWEETABLE ABSTRACT: App-treatment for female urinary incontinence cost-effective compared to care-as-usual in general practice after 12 months.


Assuntos
Medicina Geral , Aplicativos Móveis , Incontinência Urinária , Análise Custo-Benefício , Feminino , Humanos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Incontinência Urinária/terapia
3.
BJOG ; 129(9): 1474-1480, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-34437756

RESUMO

OBJECTIVE: To assess the long-term effectiveness of app-based treatment for female stress, urgency or mixed urinary incontinence (UI) compared with care-as-usual in primary care. DESIGN: A pragmatic, randomised controlled, superiority trial. SETTING: Primary care in the Netherlands from 2015 to 2018, follow up at 12 months. POPULATION: Women with two or more UI episodes per week and access to mobile apps, wanting treatment. A total of 262 women were randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended 1 year follow up. INTERVENTIONS: The standalone app included conservative management for UI with motivation aids (e.g. reminders). Care-as-usual was delivered according to the Dutch GP guideline for UI. MAIN OUTCOME MEASURES: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTSqol) with linear regression on an intention-to-treat basis. RESULTS: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6) groups, with a non-significant mean difference of 0.903 (-0.66 to 1.871). CONCLUSION: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of effectiveness after 1 year. TWEETABLE ABSTRACT: App-based treatment for female urinary incontinence is a viable alternative to care-as-usual after 12 months.


Assuntos
Medicina Geral , Aplicativos Móveis , Incontinência Urinária por Estresse , Incontinência Urinária , Feminino , Humanos , Qualidade de Vida , Incontinência Urinária/terapia , Incontinência Urinária por Estresse/terapia
4.
Neurourol Urodyn ; 41(8): 1739-1748, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35876473

RESUMO

BACKGROUND: Pelvic floor symptoms (PFS), such as lower urinary tract symptoms, defecation disorders, sexual problems, and genital-pelvic pain, are prevalent in men. Thorough physical assessments of the external anal sphincter (EAS) and the puborectal muscle (PRM) are the keys to unraveling the role of muscle dysfunction. OBJECTIVES: To explore associations within and between the EAS and PRM and between muscle (dys-) function and the number of male PFS. METHODS: This cross-sectional study purposively enrolled men aged ≥21 years with 0-4 symptoms from a larger study. After extensive external and internal digital pelvic floor assessment, we explored (1) agreement between muscle function of the EAS versus PRM (using cross tabulation), (2) associations within and between the EAS and PRM (using heatmaps), and (3) associations between muscle function and number of PFS (using a visual presentation [heatmaps] and χ2  tests). RESULTS: Overall, 42 out of 199 men (21%) had completely normal muscle function. Sixty-six (33.2%) had no symptoms, of which 53 (80%) had some degree of muscle dysfunction. No clear dose-response relationship existed between muscle (dys-) function and the number of symptoms. The PRM showed both more dysfunction and severer dysfunction than the EAS. CONCLUSIONS: No clear association exists between muscle dysfunction and the number of symptoms, and the absence of PFS does not indicate normal muscle function for all men. Dysfunction levels are highest for the PRM. Further pelvic floor muscle research is warranted in men with PFS.


Assuntos
Sintomas do Trato Urinário Inferior , Diafragma da Pelve , Humanos , Masculino , Estudos Transversais , Canal Anal , Exame Físico , Dor
5.
Neurourol Urodyn ; 41(8): 1770-1780, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35989534

RESUMO

OBJECTIVES: Researchers and clinicians tend to focus on one pelvic floor symptom (PFS) at the time. However, the pelvic floor acts as one functional unit, increasing the likelihood of concurrent PFS in patients with pelvic floor dysfunction. There is also a paucity of literature on the prevalence of concomitant PFS, especially in males. Therefore, we explored the occurrence of concomitant PFS in community-dwelling males and females. MATERIALS AND METHODS: This prospective observational population-based cohort study included males and females aged ≥16 years from a single Dutch municipality. Participants completed validated questionnaires on lower urinary tract symptoms (LUTS), defecation problems, sexual dysfunction, pelvic pain, and pelvic organ prolapse. Medical general practitioner records were examined. Furthermore, a randomly selected group of non-responders aged <80 years received a short questionnaire, to study response bias. RESULTS: We invited 11 724 people, among which 839 females and 566 males completed the questionnaires. Of the female participants, 286 (34.1%) reported no PFS, and 251 (29.9%) reported two or more PFS. The most prevalent PFS clusters in females were sexual dysfunction and pelvic pain, sexual dysfunction and defecation problems, LUTS and defecation problems, and LUTS, defecation problems, and pelvic pain. Of the male participants, 212 (37.5%) reported no PFS, and 191 (33.7%) reported two or more PFS. The most prevalent clusters in males were sexual dysfunction and LUTS, defecation problems and LUTS, and sexual dysfunction, LUTS, and defecation problems. CONCLUSION: A considerable overlap existed between PFS, with differences in PFS clusters between females and males. Of note, females reported pelvic pain more than males. We conclude that healthcare providers should address all PFS in males and females.


Assuntos
Sintomas do Trato Urinário Inferior , Distúrbios do Assoalho Pélvico , Disfunções Sexuais Fisiológicas , Humanos , Masculino , Feminino , Diafragma da Pelve , Vida Independente , Estudos de Coortes , Inquéritos e Questionários , Dor Pélvica
6.
Fam Pract ; 39(4): 662-668, 2022 07 19.
Artigo em Inglês | MEDLINE | ID: mdl-35018413

RESUMO

OBJECTIVE: Health care expenditures for children with functional constipation (FC) are high, while conservative management is successful in only 50% of the children. The aim is to evaluate whether adding physiotherapy to conventional treatment (CT) is a cost-effective strategy in the management of children with FC aged 4-18 years in primary care. METHODS: A cost-effectiveness analysis was performed alongside a randomized controlled trial (RCT) with 8-month follow-up. Costs were assessed from a societal perspective, effectiveness included both the primary outcome (treatment success defined as the absence of FC and no laxative use) and the secondary outcome (absence of FC irrespective of laxative use). Uncertainty was assessed by bootstrapping and cost-effectiveness acceptability curves (CEACs) were displayed. RESULTS: One hundred and thirty-four children were randomized. The incremental cost-effectiveness ratio (ICER) for one additional successfully treated child in the physiotherapy group compared with the CT group was €24,060 (95% confidence interval [CI] €-16,275 to €31,390) and for the secondary outcome €1,221 (95% CI €-12,905 to €10,956). Subgroup analyses showed that for children with chronic laxative use the ICER was €2,134 (95% CI -24,975 to 17,192) and €571 (95% CI 11 to 3,566), respectively. At a value of €1,000, the CEAC showed a probability of 0.53 of cost-effectiveness for the primary outcome, and 0.90 for the secondary outcome. CONCLUSIONS: Physiotherapy added to CT as first-line treatment for all children with FC is not cost-effective compared with CT alone. Future studies should consider the cost-effectiveness of physiotherapy added to CT in children with chronic laxative use. TRIAL REGISTRATION: The RCT is registered in the Netherlands Trial Register (NTR4797), on the 8th of September 2014. The first child was enrolled on the 2nd of December 2014. https://www.trialregister.nl/trial/4654.


Assuntos
Constipação Intestinal , Modalidades de Fisioterapia , Criança , Constipação Intestinal/terapia , Análise Custo-Benefício , Humanos , Atenção Primária à Saúde , Resultado do Tratamento
7.
Am J Obstet Gynecol ; 224(2): 187.e1-187.e10, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32795428

RESUMO

BACKGROUND: Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding. OBJECTIVE: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding. STUDY DESIGN: This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function. RESULTS: We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups. CONCLUSION: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.


Assuntos
Contraceptivos Hormonais/administração & dosagem , Técnicas de Ablação Endometrial/métodos , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Menorragia/terapia , Adulto , Feminino , Humanos , Menorragia/fisiopatologia , Pessoa de Meia-Idade , Países Baixos , Satisfação do Paciente , Qualidade de Vida , Retratamento , Saúde Sexual , Resultado do Tratamento
8.
Ann Fam Med ; 19(2): 102-109, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33685871

RESUMO

PURPOSE: Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting. METHODS: The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis. RESULTS: A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment. CONCLUSIONS: App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.


Assuntos
Terapia por Exercício , Aplicativos Móveis , Atenção Primária à Saúde/métodos , Qualidade de Vida/psicologia , Telemedicina , Incontinência Urinária/terapia , Adulto , Idoso , Estudos de Equivalência como Asunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Incontinência Urinária/psicologia
9.
J Pediatr ; 216: 25-31.e2, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31732133

RESUMO

OBJECTIVE: To determine the effectiveness of physiotherapy plus conventional treatment compared with conventional treatment alone for the treatment of functional constipation in children age 4-17 years in primary care. STUDY DESIGN: Pragmatic randomized controlled trial with 8 months follow-up. Primary care physicians recruited children diagnosed with functional constipation (n = 234), and pediatricians recruited newly referred children with a diagnosis of functional constipation (n = 11). Conventional treatment comprised toilet training, nutritional advice, and laxative prescribing, whereas physiotherapy focused on resolving dyssynergic defecation. The primary outcome was treatment success over 8 months, defined as the absence of functional constipation (Rome III criteria) without laxative use. Secondary outcomes included the absence of functional constipation irrespective of continuation of laxative use and global perceived treatment effect. RESULTS: Children were allocated to conventional treatment plus physiotherapy or conventional treatment alone (67 per group), mean (SD) age was 7.6 (3.5) years. Results of longitudinal analyses in the intention-to-treat population showed that the treatment success percentage was not statistically improved by adding physiotherapy to conventional treatment (adjusted relative risk [aRR] 0.80, 95% CI 0.44-1.30). At 4 months, fewer children receiving physiotherapy had treatment success (17%) than children receiving conventional treatment alone (28%), but this had equalized by 8 months (42% and 41%, respectively). The percentage of children without functional constipation, irrespective of continuation of laxative use, was not statistically different between groups over 8 months (aRR 1.12, 95% CI 0.82-1.34). Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73). CONCLUSIONS: We find no evidence to recommend physiotherapy for all children with functional constipation in primary care. TRIAL REGISTRATION: Netherlands Trial Registry: NTR4797.


Assuntos
Constipação Intestinal/terapia , Laxantes/uso terapêutico , Modalidades de Fisioterapia , Criança , Pré-Escolar , Defecação , Feminino , Humanos , Masculino , Atenção Primária à Saúde , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento
10.
Neurourol Urodyn ; 37(7): 2167-2176, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29392749

RESUMO

AIMS: We aim to assess whether a purpose-developed mobile application (app) is non-inferior regarding effectiveness and cost-effective when used to treat women with urinary incontinence (UI), as compared to care as usual in Dutch primary care. Additionally, we will explore the expectations and experiences of patients and care providers regarding app usage. METHODS: A mixed-methods study will be performed, combining a pragmatic, randomized-controlled, non-inferiority trial with an extensive process evaluation. Women aged ≥18 years, suffering from UI ≥ 2 times per week and with access to a smartphone or tablet are eligible to participate. The primary outcome will be the change in UI symptom scores at 4 months after randomization, as assessed by the International Consultation on Incontinence Modular Questionnaire UI Short Form. Secondary outcomes will be the change in UI symptom scores at 12 months, as well as the patient-reported global impression of improvement, quality of life, change in sexual functioning, UI episodes per day, and costs at 4 and 12 months. In parallel, we will perform an extensive process evaluation to assess the expectations and experiences of patients and care providers regarding app usage, making use of interviews, focus group sessions, and log data analysis. CONCLUSION: This study will assess both the effectiveness and cost-effectiveness of app-based treatment for UI. The combination with the process evaluation, which will be performed in parallel, should also give valuable insights into the contextual factors that influence the effectiveness of such a treatment.


Assuntos
Aplicativos Móveis/economia , Atenção Primária à Saúde , Qualidade de Vida , Projetos de Pesquisa , Incontinência Urinária/terapia , Adolescente , Adulto , Idoso , Análise Custo-Benefício , Terapia por Exercício/métodos , Feminino , Grupos Focais , Humanos , Pessoa de Meia-Idade , Encaminhamento e Consulta , Inquéritos e Questionários , Incontinência Urinária/economia , Adulto Jovem
11.
J Pediatr Gastroenterol Nutr ; 67(6): 726-731, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30095575

RESUMO

OBJECTIVE: Functional constipation (FC) has a major impact on the health-related quality of life (HRQoL) of children. The aim of this study was to evaluate parent-child agreement on HRQoL in children (8-17 years) with FC in primary care. METHODS: Children diagnosed with FC by their clinician were eligible. HRQoL was measured with the Defecation Disorder List (DDL, score 0-100), and the EuroQol-5-Dimension-Youth Visual Analogue Scale (EQ-5D-Y-VAS, scale 0-100). Parent-child agreement was examined with discrepancy scores, intraclass correlation coefficients and Bland-Altman plots. RESULTS: Fifty-six children, median age of 10 years (IQR 8-12) and their parents were included. Parent-child agreement at a group level was good, with an intraclass correlation coefficient of 0.80 (95% confidence interval 0.67 to 0.88) for the DDL, and 0.78 (95% confidence interval 0.65 to 0.87) for the EQ-5D-Y-VAS. Mean discrepancy scores for the DDL and EQ-5D-Y-VAS were small: -2.6 and -2.9, implying that parents were slightly more positive about the HRQoL than their children. Bland-Altman plots showed considerable discordance between individual parent-child pairs. Limits of agreement were -19.7 and 14.6 for the DDL and -27.6 and 21.8 for the EQ-5D-Y-VAS. CONCLUSIONS: There is good parent-child agreement on HRQoL in children with FC at group level. However, a substantial number of parent-child pairs differed considerably on their rating of the HRQoL of the child. Therefore, we recommend clinicians, if they want to have an impression of the impact of the FC on the HRQoL of the child, to ask both the child and the parent(s).


Assuntos
Constipação Intestinal/psicologia , Pais/psicologia , Atenção Primária à Saúde/estatística & dados numéricos , Qualidade de Vida , Inquéritos e Questionários/estatística & dados numéricos , Adolescente , Criança , Correlação de Dados , Feminino , Humanos , Masculino , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos Testes
12.
J Pediatr Gastroenterol Nutr ; 67(5): 552-560, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30212423

RESUMO

OBJECTIVE: The aim of the review is to perform a systematic review of the literature examining the prevalence of bladder symptoms in children with functional constipation (FC) and to compare the prevalence of those symptoms between children with and without FC. METHODS: In this systematic review 4 databases were searched to July 2018. Studies investigating the prevalence of bladder symptoms in children aged 4 to 17 years with FC were included. There was no language restriction. Two reviewers independently extracted data and assessed study quality. Clinical heterogeneity between studies was investigated. Prevalence rates of bladder symptoms in children with FC were calculated. Relative risks were calculated to compare the prevalence of bladder symptoms between children with and without FC. RESULTS: Among 23 studies of children with FC, 22 reported the prevalence bladder symptoms (12,281 children) and 7 reported the prevalence of urinary tract infections (UTIs) (687 children). The prevalence rates of single bladder symptoms, lower urinary tract symptoms (LUTS), and UTI varied between 2% to 47%, 37% to 64%, and 6% to 53%. The relative risks were 1.24 to 6.73 for 20 single bladder symptoms (12 studies) and 2.18 to 6.55 for UTI (2 studies). The 95% confidence intervals indicated significance in 14 of 20 single bladder symptoms. CONCLUSIONS: Bladder symptoms seem common in children with FC, but the reported prevalence varies greatly. Children with FC are more likely to have bladder symptoms than children without FC. We recommend that clinicians be aware of concomitant bladder symptoms in children presenting with FC.


Assuntos
Constipação Intestinal/complicações , Sintomas do Trato Urinário Inferior/epidemiologia , Doenças da Bexiga Urinária/epidemiologia , Infecções Urinárias/epidemiologia , Adolescente , Criança , Pré-Escolar , Constipação Intestinal/patologia , Feminino , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Masculino , Prevalência , Bexiga Urinária/patologia , Doenças da Bexiga Urinária/etiologia , Infecções Urinárias/etiologia
13.
BMC Pediatr ; 18(1): 249, 2018 07 31.
Artigo em Inglês | MEDLINE | ID: mdl-30064408

RESUMO

BACKGROUND: Our aim was to design a study to evaluate the effectiveness and cost-effectiveness of adding physiotherapy to conventional treatment for children with functional constipation in primary care. Physiotherapy is focusing on improving the coordination between the pelvic floor and abdominal musculature during bowel movement, while conventional treatment is mainly focusing on symptomatic relief of symptoms, therefore, we expect the effects of physiotherapy will be more sustainable than the effects of conventional treatment. In this paper we describe the final study design and how the design was adapted, to overcome recruitment problems. METHODS: We designed a randomized controlled trial of children aged 4-17 years with functional constipation diagnosed by a general practitioner or pediatrician. Children in the intervention group received physiotherapy plus conventional treatment, and those in the control group received conventional treatment only. Follow-up measurements took place at 4 and 8 months. The primary outcome was treatment success defined according to the Rome-III criteria as the absence of functional constipation, with no laxative use. Secondary outcomes were absence of functional constipation irrespective of laxative use, quality of life, global perceived effect, and costs. Children were recruited from September 2014 to February 2017. Initially, we aimed to include children with recent symptom onset. However, in the first phase of enrollment we were confronted with an unforeseen recruitment problem: many children and their parents refused randomization because physiotherapy was considered too burdensome for the stage of disease. Therefore, we decided to also include children with a longer duration of symptoms. In total 134 children were included. DISCUSSION: The target number of participants is achieved. Therefore, the results may change thinking about the management of functional constipation in children. TRAIL REGISTRATION: Netherlands Trial Register ( NTR4797 ), registered 8 September 2014.


Assuntos
Constipação Intestinal/terapia , Modalidades de Fisioterapia , Adolescente , Criança , Pré-Escolar , Terapia Combinada , Constipação Intestinal/dietoterapia , Constipação Intestinal/fisiopatologia , Análise Custo-Benefício , Feminino , Seguimentos , Humanos , Laxantes/uso terapêutico , Masculino , Seleção de Pacientes , Modalidades de Fisioterapia/economia , Qualidade de Vida , Projetos de Pesquisa , Treinamento no Uso de Banheiro
14.
Am J Obstet Gynecol ; 216(4): 397.e1-397.e7, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-27751796

RESUMO

BACKGROUND: The Pelvic Floor Distress Inventory-20 is used to evaluate symptoms and treatment effects in women with pelvic floor disorders. To interpret changes in the scores of this inventory, information is needed about what patients and clinicians perceive as the minimal important (meaningful) change. Although this change in the inventory score has been investigated previously in women who have undergone pelvic floor surgery, the results could not be generalized to women with milder symptoms (ie, lower scores) who often require only conservative treatment. OBJECTIVE: We aimed to estimate the minimal important change in the Pelvic Floor Distress Inventory-20 that was needed to demonstrate clinical improvement in women who qualify for conservative pelvic floor treatment. STUDY DESIGN: The data of 214 women aged ≥55 years were used. All participants were from 2 randomized controlled trials that compared conservative prolapse treatments in primary care in The Netherlands. The degree of prolapse was assessed with the use of the Pelvic Organ Prolapse Quantification system; participants completed the Pelvic Floor Distress Inventory-20 at baseline and at 12 months, with a global perception of improvement question at 12 months. To assess both the patient perspective and the clinical perspective, 2 anchors were assessed: (1) the global perception of improvement was considered the anchor for the patients' perspective, and (2) the difference in the degree of prolapse was considered the anchor for the clinical perspective. Provided that the anchors were correlated by at least 0.3 to the Pelvic Floor Distress Inventory-20 change scores, we estimated the following minimal important changes: (1) the optimal cutoff-point of the receiver operating characteristics curve that discriminates between women with and without improvement in the global perception of improvement scale and (2) the mean Pelvic Floor Distress Inventory-20 change score of participants who improved 1 assessment stage. We then calculated the smallest detectable change to check whether the minimal important change was larger than the measurement error of the questionnaire. RESULTS: Using the global perception of improvement as the anchor, we found a minimal important change for improvement of 13.5 points (95% confidence interval, 6.2-20.9). The Pelvic Organ Prolapse Quantification change scores correlated poorly to the Pelvic Floor Distress Inventory-20 change scores and therefore could not be used as an anchor. The smallest detectable change at the group level was 5.5 points. Thus, the minimal important change was larger than the smallest detectable change at the group level. CONCLUSION: In women with relatively mild pelvic floor symptoms, an improvement of 13.5 points (or a 23% reduction) in the Pelvic Floor Distress Inventory-20 score can be considered clinically relevant. This minimal important change can be used for clinical trial planning and evaluation of treatment effects in women whose condition is considered suitable for conservative treatment.


Assuntos
Prolapso de Órgão Pélvico/terapia , Índice de Gravidade de Doença , Inquéritos e Questionários , Idoso , Tratamento Conservador , Terapia por Exercício , Feminino , Humanos , Pessoa de Meia-Idade , Diafragma da Pelve , Pessários , Curva ROC
15.
Int Urogynecol J ; 28(2): 307-313, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27525693

RESUMO

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common condition. There is inconsistency between predictors of unsuccessful pessary fitting in urological/gynaecological clinics. Research in general practice is scarce. The aim was to estimate the proportion of women in general practice with a symptomatic pelvic organ prolapse and unsuccessful pessary fitting, and to identify characteristics associated with unsuccessful pessary fitting. METHODS: A cross-sectional study in general practice (n = 20) was carried out among women (≥55 years) with symptomatic prolapse (n = 78). Multivariate logistic regression analysis was used to identify predictors of unsuccessful pessary fitting. RESULTS: In total, 33 women (42 %) had unsuccessful pessary fitting. Factors associated with unsuccessful pessary fitting were age (per year, OR 0.93 [95 % CI 0.87-1.00]), body mass index (per kg/m2, OR 1.14 [95 % CI 1.00-1.30]), and having underactive pelvic floor muscles (OR 2.60 [95 % CI 0.81-8.36]). CONCLUSIONS: Pessary fitting was successful in 58 %, indicating that pessary treatment may be suitable for many, but not for all women in general practice with symptomatic prolapse. The condition of the pelvic floor probably plays a role in the success of pessary fitting, as demonstrated by the association with underactive pelvic floor muscles, and body mass index. The association with age may reflect the higher acceptance of conservative treatments for prolapse in older women. This is the first study on predictive factors for unsuccessful pessary fitting in general practice. Therefore, further research should seek to confirm these associations before we can recommend the use of this information in patient counselling.


Assuntos
Prolapso de Órgão Pélvico/terapia , Pessários/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Fatores Etários , Idoso , Índice de Massa Corporal , Estudos Transversais , Feminino , Humanos , Pessoa de Meia-Idade , Diafragma da Pelve/fisiologia , Análise de Regressão , Fatores de Risco , Resultado do Tratamento
16.
Fam Pract ; 34(6): 673-678, 2017 11 16.
Artigo em Inglês | MEDLINE | ID: mdl-28586411

RESUMO

Background: Heavy menstrual bleeding (HMB) is a common problem in women of reproductive age. In 2008, the Dutch guideline for general practitioners (GPs) was revised to recommend the levonorgestrel intrauterine system (LNG-IUS) as a first-choice treatment for HMB. However, GP prescribing practices have not been studied in depth. Objectives: To investigate the incidence and initial treatment of HMB in general practice, and to identify if there were changes in prescribing practices after the revision of the national guideline in 2008. Methods: Retrospective analysis of data from the Registration Network Groningen, the Netherlands. We selected data for prescriptions and referrals related to women consulting their GP for HMB between 2004 and 2013. We calculated the incidence rates and investigated potential trends in prescribing over time, with particular attention to the prescribing of LNG-IUS. Results: Over 10 years, 881 women consulted their GP for HMB, with a mean annual incidence of 9.3 per 1000 person years (95% confidence interval: 8.5-10.2). Most women received hormonal treatment (406/881; 46%) within three months of diagnosis, but many (387/881; 44%) received no medication. The LNG-IUS was prescribed for 2.4%, but there was no significant increase in the number of prescriptions over time. Conclusion: In this cohort, most women with HMB were treated with oral hormone therapy, and few received the LNG-IUS. If patients are to benefit from the LNG-IUS, further research is needed into the reasons for this lack of change in prescribing practices.


Assuntos
Guias como Assunto , Menorragia/tratamento farmacológico , Menorragia/epidemiologia , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Feminino , Medicina Geral/estatística & dados numéricos , Humanos , Incidência , Dispositivos Intrauterinos Medicados/estatística & dados numéricos , Levanogestrel , Países Baixos/epidemiologia , Sistema de Registros , Estudos Retrospectivos
19.
J Sex Med ; 11(7): 1757-65, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24735276

RESUMO

INTRODUCTION: Knowledge on the sexual health of patients with urinary incontinence in primary care is scarce; therefore, the impact of urinary incontinence on sexual functioning was examined in community-dwelling older women. AIM: The aim of this study was to provide primary health care professionals with more information on the sexual health of older women with urinary incontinence, which can be used to discuss this sensitive topic during a consultation. METHOD: A cross-sectional survey among the 350 women aged ≥55 years participating in a primary care trial on urinary incontinence was conducted. MAIN OUTCOME MEASURES: Among patients with a partner, sexual problems of the sexually active patients were described as well as reasons for not being sexually active. A multivariate logistic regression model was performed to identify factors that are predictors of sexual activity, and odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. RESULTS: Of all participants with a partner, 68% (95% CI: 61-74) were sexually active. Of these, 25% (95% CI: 17-35) felt restricted in (or avoided) sexual activity because of their urinary incontinence. Urine leakage during sexual activity was present in 26% (95% CI: 19-34). The most frequent reason for not being sexually active was a physical problem of their partner (28%, 95% CI: 18-40); only 5% (95%-CI: 2-13) reported that urinary incontinence was a reason for not having sex. Increasing age was the only independent (negative) predictor of sexual activity (OR: 0.95, 95%-CI: 0.90-1.00). CONCLUSIONS: Most of these older women with urinary incontinence were sexually active, if they had a partner. The main reason for not being sexually active was a partner-related problem. Although for only 5% was urinary incontinence the main reason for not having sex, about 25% of the sexually active women reported a negative influence of urine loss on their sex life. This implies that assessing sexual function is relevant in older women with urinary incontinence.


Assuntos
Disfunções Sexuais Psicogênicas/etiologia , Incontinência Urinária/psicologia , Idoso , Coito/psicologia , Estudos Transversais , Feminino , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Razão de Chances , Ensaios Clínicos Controlados Aleatórios como Assunto , Comportamento Sexual/psicologia , Comportamento Sexual/estatística & dados numéricos
20.
Lancet ; 389(10067): 336-337, 2017 01 28.
Artigo em Inglês | MEDLINE | ID: mdl-28010990
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