Transvaginal repair of anterior vaginal wall prolapse with polyvinylidene fluoride (PVDF) mesh: an alternative for previously restricted materials?

INTRODUCTION AND HYPOTHESIS: To study the mid-term safety and functional outcomes of transvaginal anterior vaginal wall prolapse repair using polyvinylidene fluoride (PVDF) mesh (DynaMesh®-PR4) by the double trans-obturator technique (TOT). METHODS: Between 2015 and 2020, we prospectively included women with symptomatic high-stage anterior vaginal wall prolapse with or without uterine prolapse or stress urinary incontinence (SUI) in the study. The patients underwent transvaginal repair of the prolapse using PVDF mesh in two medical centers. We followed all patients for at least 12 months. We recorded the characteristics of vaginal and sexual symptoms, urinary incontinence, and prolapse stage pre- and postoperatively using International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF), and Pelvic Organ Prolapse Quantification (POP-Q) system, respectively. RESULTS: One hundred eight women were included in the final analysis with a mean follow-up time of 34.5 ± 18.6 months. The anatomical success was achieved in 103 (95.4%) patients. There was a significant improvement in patients' vaginal symptoms, urinary incontinence, and quality of life scores postoperatively (p < 0.0001). Only six patients (5.5%) had mesh extrusion, five of whom were managed successfully. The total rates of complications and de novo urinary symptoms were 21.3% and 7.4%, respectively. Significant pain was reported in 17 cases (15.7%). CONCLUSION: Our findings show that using PVDF mesh in the double TOT technique for anterior vaginal wall prolapse repair is a safe procedure with high anatomic and functional success rates and acceptable complication rates in mid-term follow-up.

A comprehensive mental health care program for women with polycystic ovary syndrome: protocol for a mixed methods study.

BACKGROUND: Psychological health is related to the management of polycystic ovary syndrome (PCOS) and is an essential component of self-efficacy and enjoying a healthy lifestyle. Need assessment and plans to improve the psychological health of these women provides significantly valuable information to design an advantageous intervention program to reach that goal. Therefore, this study will conduct to improve the psychological health for women with PCOS through a designed comprehensive care. METHODS: This is an exploratory mixed method study using consecutive qualitative-quantitative methods, including three consecutive phases. In the first phase, a qualitative study will be conducted to assess their needs and will design a care protocol for improving mental health of women with PCOS. Participants in this phase will select by purposive sampling method and data will collect using semi-structured interviews by taking notes at same time. Data will analyze using conventional content analysis method. At second phase, according the information obtained from previous phase and a literature review a comprehensive program to mental health care will be proposed. Then multidisciplinary team will review and finalize it according to priorities. The third phase will follow a quantitative approach using quasi-experimental study with two groups to measure the effectiveness of this program on the women's psychological health. DISCUSSION: Designing a program based on a qualitative study and a review article and updated evidences can lead to improving of these women's psychological health and quality of life. Consequently, we expect to show that mental health program provided by a multidisciplinary team improves reproductive outcomes while at the same time being cost-effective in women with PCOS.

Atorvastatin effect on systemic lupus erythematosus disease activity: a double-blind randomized clinical trial.

We aimed to evaluate the therapeutic effects of atorvastatin on systemic lupus erythematosus disease activity index (SLEDAI). Ninety patients with SLE were consented and randomized to receive either atorvastatin, 20 mg/day, or placebo for 3 months. The primary outcome was change in SLEDAI. Lipids, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were assessed as secondary end points. Analysis was done by "intention to treat" (ITT) as the primary analysis and "treatment completed analysis" (TCA) as the supplementary analysis. Demographic features, baseline characteristics, and distribution of medications were not significantly different between the two groups. Mean SLEDAI score at baseline in both groups was 3 ± 0.5. By TCA and ITT, mean SLEDAI scores decreased to 1.7 ± 0.4 and 2.7 ± 0.5, respectively, in the atorvastatin group and 3 ± 0.4 and 3 ± 0.5, respectively, in the control group. The difference between the two groups after intervention was significant by TCA (P < 0.05) and nonsignificant by ITT analysis (P = 0.1). The effect of atorvastatin therapy on lupus activity was inconclusive.

Spiritual well-being and quality of life of Iranian adults with type 2 diabetes.

Introduction. Diabetes is a major public health problem. Little is known about the spiritual well-being and its relationship with quality of life (QOL) in Iranian Muslim patients with diabetes. This study investigated the spiritual well-being and QOL of Iranian adults with type 2 diabetes and the association between spiritual well-being, QOL, and depression. Methods. A cross-sectional study was done among 203 patients with type 2 diabetes mellitus in Isfahan, Iran. Quality of life and spiritual well-being were measured using the functional assessment of chronic illness therapy-spiritual well-being (FACIT-Sp). Depression was assessed using the Patient Health Questionnaire-2 (PHQ-2). Descriptive analysis, Pearson's correlation, and multiple regression analysis were performed for statistical assessment. Results. The mean QOL was 61.00 (SD = 9.97) and the mean spiritual well-being was 30.59 (SD = 6.14). Sixty-four percent of our studied population had depressive disorders. There was a significant positive correlation between all QOL subscales and meaning, peace, and total spiritual well-being score. Conclusion. The results of this study showed poor QOL and spiritual well-being and high prevalence of depression in Iranian patients with type 2 diabetes compared to other studies' findings especially western studies. This indicates the need for psychosocial and spiritual support in caring for Iranian patients with diabetes.

Spiritual therapy to improve the spiritual well-being of Iranian women with breast cancer: a randomized controlled trial.

Purpose. The aim of this study was to investigate the role of spiritual therapy intervention in improving the spiritual well-being and quality of life (QOL) of Iranian women with breast cancer. Methods. This randomized controlled clinical trial (RCT) recruited 65 women with breast cancer, randomly assigned to a 6-week spirituality-based intervention (n = 34) or control group (n = 31). Before and after six-week spiritual therapy intervention, spiritual well-being and quality of life (QOL) were assessed using Functional Assessment of Chronic Illness Therapy Spiritual Well-being scale (FACIT-Sp12) and cancer quality-of-life questionnaire (QLQ-C30), respectively. t-test, Paired t-test, pearson's correlation, and hierarchical regression analyses were used for analysis using Predictive Analytic software (PASW, version 18) for Windows. Results. After six spiritual therapy sessions, the mean spiritual well-being score from 29.76 (SD = 6.63) to 37.24 (SD = 3.52) in the intervention group (P < 0.001). There was a significant difference between arms of study (F = 22.91, P < 0.001). A significant positive correlation was detected between meaning and peace with all subscales of functional subscales on European Organization for Research and Treatment of Cancer quality of Life (EORTC QLQ-C30) (P < 0.05). Hierarchical regression analyses of participants indicated that the study arm, pain, and financial impact were significant predictors of spiritual well-being and overall QOL. Social functioning was another significant predictor of spiritual well-being. Conclusion. The results of this randomized controlled trial study suggest that participation in spiritual therapy program is associated with improvements in spiritual well-being and QOL. Targeted interventions to acknowledge and incorporate spiritual needs into conventional treatment should be considered in caring of Iranian patients with breast cancer.

The effect of spiritual therapy for improving the quality of life of women with breast cancer: a randomized controlled trial.

Diagnosis of breast cancer is a devastating psychological experience for a woman. Also, treatments such as radiation therapy may cause psychosocial distress in these patients and threaten their quality of life (QOL). Among several approaches, spirituality has been shown to be significantly associated with improving the QOL. The aim of this study was to assess the role of spiritual therapy intervention in improving the QOL of patients with breast cancer undergoing radiation therapy. This was a randomized controlled trial study undertaken in a radiotherapy clinic, Isfahan, Iran. Between October 2010 and February 2011, 68 patients under radiation therapy were randomized to either spiritual therapy intervention group or control group who received routine management and educational programs. Before and after six weeks of spiritual therapy sessions, the QOL was evaluated using Cancer quality-of-life questionnaire (QLQ)-C30 and breast cancer-specific questionnaire (BR-23). Multivariate, repeated-measures ANOVA, t-test, and Paired t-test were used for analysis using Predictive Analytic Soft Ware (PASW, version 18) for windows. In all, 65 patients actually completed the six-week intervention and were evaluated for the outcome. The mean Global health status score/QOL reached from 44.37 (SD = 13.03) to 68.63 (SD = 10.86), (p = 0.00). There was a statistically significant difference in all functional scales of QLQ-C30 after intervention (p < 0.05). The results of this trial showed that the spiritual therapy program can improve the overall QOL of women with breast cancer; therefore, it could be adopted in comprehensive care programs for women with breast cancer.

Translation and validation of the Persian version of the functional assessment of chronic illness therapy-Spiritual well-being scale (FACIT-Sp) among Muslim Iranians in treatment for cancer.

OBJECTIVE: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp) scale is a valid and reliable instrument to provide an inclusive measure of spirituality in research and clinical practice. The aim of this study was to translate and investigate the reliability and validity of the Persian version of the FACIT-Sp. METHOD: The 12 item spiritual well-being subscale of the FACIT-Sp Version 4 was translated into the Persian language, Farsi, using the FACIT translation methodology. The questionnaire was administered to a diverse sample of 153 patients in treatment for cancer. Internal consistency was assessed by Cronbach's α coefficient, confirmatory factor analysis (CFA) was applied to assess construct validity, and regression analysis was used to assess the predictor role of the FACIT-Sp in health-related quality of life (HRQOL). RESULTS: Cronbach's α reliability coefficient for the FACIT-Sp subscales ranged from 0.72 to 0.90. The CFA generally replicated the original conceptualization of the three subscales of the FACIT-Sp12 (Peace, Meaning, and Faith). All three subscales significant predicted HRQOL. SIGNIFICANCE OF RESULTS: The Persian version of the FACIT-Sp scale is a reliable and valid tool for the clinical assessment of, and research into, the spiritual well-being of Muslim Iranian and Farsi-speaking patients in other regions of the world who are in treatment for cancer.

Spiritual well-being and quality of life in Iranian women with breast cancer undergoing radiation therapy.

PURPOSE: Psychological distress and morbidity are common consequences of diagnosis and treatment of breast cancer and associated with poor quality of life (QOL). Spiritual well-being is an important aspect of QOL, but little is known about the spiritual well-being and its relationship with QOL in patients of different cultures such as Iranian Muslim patients. The aim of this study was to investigate the association of QOL and spirituality among patients with breast cancer undergoing radiation therapy. METHODS: This was a cross-sectional study which was conducted in the Breast Cancer Research Center of St. S. Al-Shohada Hospital, Isfahan, Iran. Spiritual well-being was measured using the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp12). The European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and its supplementary breast cancer questionnaire (QLQ-BR23) were used to assess the quality of life of patients. Descriptive analysis, Pearson's correlation, and multiple regression analysis were performed for statistical assessment. RESULTS: In all, 68 patients fulfilled the study's inclusion criteria and were interviewed. The mean global QOL was 41.42 (SD = 18.02), and the mean spiritual well-being was 28.41 (SD = 6.95). There was a significant positive correlation between general QOL and total spiritual well-being scores. Also, spiritual well-being, social functioning, pain, and arm symptoms were significant predictors of global QOL. DISCUSSION: The results of this study provide evidence that breast cancer survivors in Iran experience a poor quality of life across a broad spectrum of health domains, particularly social, emotional, and spiritual, indicating that psychosocial-spiritual support should be considered in caring for patients with breast cancer.

Association of vitamin D deficiency and coronary artery disease with cardiovascular risk factors.

BACKGROUND: Vitamin D deficiency is a prevalent condition in many countries. The aim of this study is to elucidate whether deficient vitamin D status is associated with coronary artery disease considering cardiovascular risk factors. MATERIALS AND METHODS: We measured 25 (OH) D serum levels in 57 patients that were diagnosed with coronary artery disease upon coronary angiography and 62 individuals in the control group who were matched for age and sex with the patients and examined the association between serum 25 (OH) D and coronary artery disease with regard to cardiovascular risk factors. RESULTS: The odds ratio of being affected by coronary artery disease in individuals with vitamin D deficiency (25 (OH) D < 30 ng/ml) was 5.8 (1.77 - 18.94) after adjustment with cardiovascular risk factors, i.e., blood pressure, diabetes, smoking, obesity, physical activity and high blood cholesterol in comparison with the control group. CONCLUSION: Low levels of 25 (OH) D are associated with prevalent coronary artery disease independent of cardiovascular risk factors. Further investigations could demonstrate the need for vitamin D supplementations in order to prevent atherosclerosis.