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EFFICACY OF BIOAPIGYN OINTMENT FOR PELVIC MUSCLE TONUS IN THE TREATMENT OF STRESS URINARY INCONTINENCE AND VULVOVAGNAL DISORDERS
Abstract
Objectives: The purpose of this work was development, formulation and testing of new herbal ointment for the treatment of stress urinary incontinence and its related symptoms and comparison of its efficiency with the results of pelvic muscle training. The influence of the treatment or training onto vulvo-vaginal disorders was also determined.
Materials and methods: 132 women in the age range from 32 to 77 years were randomly selected into experimental and control group. The experimental group was treated two weeks with Bioapigyn ointment for pelvic muscle tonus (2 g/day) which consisted of the following ingredients: honey; glycerol, Cera flava, oil macerates of the plants Capsella bursa-pastoris, Urtica diodica, Quercus robur, Salvia officinalis, Achillea millefolium, Alchemilla vulgaris, Calendula officinalis, Matricaria chamomilla, Plantago major; essential oils of the plants Melaleuca alternifolia, Thymus vulgaris ct. tymol, Origanum vulgare. Control group was subjected to pelvic muscle training during 24 weeks (three times a week). The degree of incontinence and its impact on the quality of life prior and after the treatment or training was assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF), where maximum score of 21 represents permanent incontinence and 0 no leakage of urine. The volume of residual urine, perineometry and vaginal pH were also determined before and after the treatment or training. For statistical evaluation STATISTICA 11.0 package was used.
Results: The variables with the highest, statistically significant influence onto degree of incontinence and its impact on the quality of life were body mass index and menopause. Significant decrease following the treatment with Bioapigyn ointment was found for ICIQ-UI SF score (from 12.43±4.83 to 8.61±4.92, p<0.00001), residual urine volume (from 8.73±11.18 to 2.78±5.93 mL, p=0.0002) and vaginal pH (from 6.30±0.63 to 5.59±0.50, p= 0.0000). The increase in the muscle strength was also confirmed. In the end of the treatment all the symptoms of vulvo-vaginal disorders disappeared completely in all 66 participants. Control group also showed some improvement in the values of ICIQ-UI SF score, residual urine and perineometry results. However, those changes were not statistically significant. There was no improvement concerning the vaginal pH and the symptoms of vulvo-vaginal disorders.
Conclusion: Preliminary study confirmed the efficiency of Bioapigyn ointment for pelvic muscle tonus in the treatment of stress urinary incontinence as well as the symptoms of vulvo-vaginal disorders due to its components with smooth muscle contraction activity, uterotonic activity as well as pH adjusting, coating, moisturizing and soothing effect. Significantly better results for most of the variables were found in the experimental compared to the control group.
... p=0.1770). In the previous study (Oreščanin et al., 2018), following the six months of PFMT the mean value of ICIQ-UI SF score slightly decreased from 8.34±4.21 to 7.92±4.71, which was not statistically significant. ...
... ICIQ-UI-SF score decreased 9.8%, perineometry parameters increased between 4.3 and 8.3% while residual urine volume decreased for 9.1%. Better results for perineometry parameters were obtained following six months PFMT (Oreščanin et al., 2018) with increase ranging between 7.3 and 26.4%. ...
... Current results for the experimental group were significantly better compared to the previous study (Oreščanin et al., 2018) lasting only two weeks which resulted in 30.7% decrease of the mean value of ICIQ-UI score, 68.2% decrease of residual urine volume, 11.3% decrease of vaginal pH and between 25.3 and 31.7% increase of perineometry parameters. However, two weeks of the treatment were long enough for complete disappearance of vulvo-vaginal complaints. ...
Objective/Purpose: The purpose of this work was the assessment of the clinical efficacy and safety of Bioapigyn® vaginal ointment for pelvic muscle tonus compared to pelvic floor muscle training in alleviating the symptoms of stress, urge and mixed urinary incontinence and vulvo-vaginal disorders in child-bearing and menopausal & postmenopausal women. Materials and Methods: The experimental group consisted of 66 women was treated 28 days with Bioapigyn® ointment for pelvic muscle tonus (2.5 mL/day). The control group also consisted of 66 participants was subjected to pelvic floor muscle training during 28 days (five times a day). ICIQ-UI SF score, the residual urine volume, perineometry, the total score of vulvo-vaginal symptoms and vaginal pH were determined before and after the treatment or training. Results: Following the treatment with Bioapigyn® ointment ICIQ-UI-SF score decreased 54.9%, perineometry parameters increased between 31.5 and 34.3%, residual urine decreased for 76.9% and vaginal pH for 14.2%. All the symptoms of vulvo-vaginal disorders disappeared completely in all participants. The control group showed no changes in vaginal pH or the improvement concerning the vulvo-vaginal complaints. ICIQ-UI-SF score decreased for 4.3%, residual urine volume for 9.1% while perineometry parameters increased between 4.3 and 8.3%. Conclusion/Discussion: Bioapigyn® vaginal ointment for pelvic muscle tonus alleviate the symptoms of incontinence by tightening and firming of the smooth muscles of the pelvic floor thanks to the ingredients with smooth muscles contraction/relaxation and astringent properties. Low pH, high osmolarity, viscosity, greasiness and coating effect of the ointment eradicated vulvo-vaginal complaints.
The purpose of this work was development, formulation and testing of new herbal ointment for the treatment of stress urinary incontinence and its related symptoms. 50 women in the age range from 36 to 73 years were treated 8 weeks with vaginal ointment (2 g/day) which consisted of the following ingredients: oil macerates of the plants Capsella bursa-pastoris, Urtica diodica, Quercus robur, Quercus infectoria, Corylus avellana, Ocimum basilicum, Salvia officinalis, Achillea millefolium, Calendula officinalis, Matricaria chamomilla, Hypericum perforatum, Alchemilla vulgaris, Thymus serpyllum, Plantago major, Symphytum officinale; essential oils of the plants Melaleuca alternifolia, Cymbopogon martinii, Cinnamomum camphora ct. cineol, Eugenia caryophylata, Thymus vulgaris ct. tymol, Origanum vulgare; honey; glycerin and Cera flava. The degree of incontinence and its impact on the quality of life prior and after the therapy was assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), where maximum score of 21 represents permanent incontinence and 0 no leakage of urine. Sexual gratification was assessed by the Pelvic organ prolepses / urinary Incontinence / Sexual Questionnaire (PISQ-12). The variables with the highest, statistically significant influence onto degree of incontinence and its impact on the quality of life were were Urine leak and related symptoms, Menopause, Frequent urinary tract infections, Age and Number of childbirth. Significant improvement concerning both, incontinence (p<0.0001) and sexuality (p<0.0003) was observed following two weeks of the application. In the end of the study the mean value of ICIQ-UI score decreased from 10.3±4.2 to 1.1±1.0 while PISQ-12 increased from 21.0±2.9 to 28.4±3.2. Following the eight weeks of the therapy 66% of the patients were completely dry, while other 34% exhibited only slight problems (ICIQ-UI score range 1-3). After only 7 days of the application the symptoms like burning, vaginal discharge, vaginal dryness and painful sexual intercourse decreased significantly while in the end of the treatment disappeared completely. ABSTRACT KEYWORDS : herbal ointment, stress urinary incontinence, olive oil extracts, medicinal plants, essential oils INTRODUCTION The International Continence Society Standardization of Terminology of Lower Urinary Tract Dysfunction established clinical definition of stress urinary incontinence (SUI) as the complaint of involuntary leakage during effort or exertion, or on sneezing or coughing (Luber, 2004). Its prevalence ranged between 4% and 35% depending on the country with age, obesity, and smoking as the most significant risk factors (Luber, 2004). Nygaard and Heit, 2004 reported that SUI occurs at least weekly in one third of adult women. Among 20,000 Chinese women in the age range from 20 to 99 years the prevalence of SUI was 18.9% (Zhu et al., 2009) and the significant risk factors are age, vaginal delivery, multiparty, alcohol consumption, central obesity constipation, chronic pelvic pain, history of respiratory disease, gyne-cological events, pelvic surgery, and perimenopause and postmeno-pause status. Among 1700 French women employed in academic hospital, 12.4% of them reported SUI (Peyrat et al., 2002). The pregnancy , particularly previous vaginal delivery and hysterectomy represented the significant risk factors. The prevalence of SUI reported by Minassian et al., 2008 among 2,875 adult women was 23.7%. The obtained significant risk factors were age, ethnic background, weight, parity and hysterectomy. Among 83,355 American nurses at the age range from 37 to 54 years 43% of them reported incontinence. Identified risk factors were age, race/ethnicity, body mass index, parity, smoking, type 2 diabetes mellitus, and hysterectomy (Danforth et al., 2006). A world wide survey conducted by McPhil, 2004 reviled the highest percentages of women with SUI in UK (41%) and Canada (42%) and the lowest percentage was obtained in Spain (23%) while the mean value for all tested countries was 32%. Two-thirds of the symptomatic women were younger than 50. Higher prevalence of SUI (Brown, et al., 1999) was obtained among postmenopausal women (56%).
The purpose of this work was to test the efficiency of newly developed herbal pessaries for the treatment
of the squamous endocervical metaplasia compared to the conventional treatment with albothyl pessaries. The influence of the predictor variables on the outcome of the therapy was also assessed. 192 women in
the age range from 20 to 59 years (38.2±8.2) represented experimental group and 30 women ranging from 24 to 59 years (39.4±7.9) represented control group, both diagnosed with squamous endocervical metaplasia were included in the study. The patients from the experimental group were treated locally for 10 days with herbal pessaries containing macerates (Calendula officinalis, Matricaria chamomilla, Lavandula officinalis, Hypericum perforatum L., Achilea millefolium, Thymus serpyllum, Salvia officinalis, Mentha piperita L., Symphytum officinale, Plantago major L., Alchemilla vulgaris) and essential oils (Melaleuca alternifolia, Thymus vulgaris, Pelargonium graveolens, Cympobogon martinii, and Origanum vulgare L.) The patients were treated 10 days with either albothyl (control group) or herbal pessaries (experimental group). New herbal pessaries showed significantly higher efficiency ( =8.39; P=0.0038) in eradication of metaplasia compared to albothyl. Total clearance was observed in 91.15% and 66.67% of the patients in the xperimental
and control group, respectively. Among the predictor variables, health status of the patients had the highest,
statistically significant influence on the outcome of the therapy. The synergistic effect of the medicinal plants with well known wound healing, anti-inflammatory, antimicrobial and antiviral properties could be responsible for high treatment potential of the pessaries. This new product could present good alternative to the conventional treatment of squamous endocervical metaplasia due to high treatment efficiency and no observed side effects during the therapy.
The main purpose of this work was to test the efficiency of newly developed herbal pessaries to prevent
antibiotic-associated yeast infection during the treatment of Ureaplasma urealytium with doxycycline. Besides, the influence of the pessaries on the efficacy of the treatment of other bacterial, yeast and viral infections as well as low grade cervical intraepithelial lesions was also assessed. 93 women in the age range from ranged 19 to 64 years (34.4±9.3) represented experimental group and 97 women ranging from 22 to 60 years (32.7±6.3) represented control group, both infected with Ureaplasma urealytium were included in the study. The patients from the experimental group were treated with doxycycline for 12 days and locally for 10 days with new herbal pessaries while the control group was treated with doxycycline and gyno-daktarin pessaries. Significantly higher efficiency was obtained for the experimental group (x2=8.39; P=0.0038) in eradication of U. urealytium (91.5%) compared to the control group (69.1%). Besides, complete eradication of M. hominis and C. trachomatis was also observed in the experimental group. All the swabs were negative to Candida sp. following the treatment with herbal pessaries compared to 26.8% positive swabs in the case of gyno-daktarin treatment. A significant improvement was also observed in the results of Pap test following the treatment with new herbal pessaries (x2 = 23.3; P < 0.0000). Among the predictor variables, the type of the therapy had the highest, statistically significant influence on the outcome of the therapy. The synergistic effect of the medicinal plants with well known wound healing, anti-inflammatory, antimicrobial and antiviral properties could be responsible for high treatment potential of the pessaries. This new product is superior to miconazole in the prevention of antibiotic-associated yeast infection.
Menopause is suspected with age, cessation of menstruation for more than a year and presence of symptoms. The diagnosis of menopause is confirmed by follicle stimulating hormone (FSH) levels >40 IU/L. Few studies have focused on vaginal pH for menopausal diagnosis. It is a simple, non-invasive and inexpensive method for this purpose.
The following study is to correlate the serum follicle stimulating hormone (FSH) level with vaginal pH estimation in menopause.
This is a cross-sectional descriptive study conducted in 173 women aged 31-60 years with menopausal symptoms who attended the Menopausal Clinic of our hospital from January 2012 to January 2013. Vaginal pH was measured using pH micro-meter strips and serum FSH levels were measured using immunoassay methods. The data obtained was then analyzed using Statistical Package for the Social Sciences software (version 17) and results were evaluated statistically by the Chi-square and Kappa tests. P ≤ 0.05 was considered to be statistically significant.
According to our study of the 173 women studied, mean FSH level was 46.5 IU/L and mean vaginal pH was 5.3. If the menopausal hallmark is considered to be vaginal pH >4.5 and serum FSH ≥40 IU/L, the sensitivity of vaginal pH for menopausal diagnosis was 84.9% and of serum FSH is 77.4%, respectively.
Vaginal pH is a simple, accurate and cost-effective tool that can be suggested as a suitable and better alternative to serum FSH estimation for the diagnosis of menopause.
Capsella bursa-pastoris (L.) Medik. (Brassicaceae) is a wild herb with high nutritional value that can be eaten raw or cooked. A metabolomic study was performed with different extracts of its aerial parts that were tested concerning their antiradical, acetylcholinesterase inhibitory and antibacterial activities. Phenolic compounds were identified and quantified by HPLC-DAD, organic acids and amino acids were determined by HPLC-UV, while free fatty acids and sterols were analysed by GC-ITMS. The vegetal material was rich in kaempferol-3-O-rutinoside (mean value 2247.09 mg/kg of dry plant), quinic acid (95628.00 mg/kg of dry plant), arginine (mean value of 1.18 mg/kg of dry plant), palmitic acid (284.48 mg/kg) and β-sitosterol (28%). The extracts presented a concentration-dependent antiradical activity (against DPPH, O2- and LOO), being most effective against NO (EC25 0.20 µg/mL). In addition, the extracts were also acetylcholinesterase inhibitors and antibacterial active, revealing that, besides the plant's good nutritional value, it presents important biological properties as well.
Aqueous extracts of leaves of different hazel (Corylus avellana L.) cultivars (Cv. M. Bollwiller, Fertille de Coutard and Daviana), were analysed by reversed-phase HPLC/DAD for the definition of their phenolic composition. Antioxidant potential was assessed by the reducing power assay, and the scavenging effect on DPPH (2,2-diphenyl-1-picrylhydrazyl) radicals and β-carotene linoleate model system. Their antimicrobial capacity was also tested against Gram positive (Bacillus cereus, Bacillus subtilis, Staphylococcus aureus) and Gram negative bacteria (Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae) and fungi (Candida albicans, Cryptococcus neoformans). Eight phenolic compounds were identified: 3-, 4- and 5-caffeoylquinic acids, caffeoyltartaric acid, p-coumaroyltartaric acid, myricetin-rhamnoside, quercetin 3-rhamnoside and kaempferol 3-rhamnoside. A p-coumaric acid, three myricetin and one quercetin derivatives were also detected. The hazel leaves extract presented high antioxidant activity in a concentration-dependent way, in general with similar behaviour of all cultivars. Gram positive bacteria revealed to be very sensitive to hazel leaf extract (MIC 0.1 mg/ml for B. cereus and S. aureus and 1 mg/ml for B. subtilis). However, Gram negative and the fungi displayed much lower sensitivity, being P. aeruginosa and C. albicans resistant at 100 mg/ml. Cv. M. Bollwiller exhibited the most potent antimicrobial activity.
Perinatally, and between menarche and menopause, increased levels of estrogen cause large amounts of glycogen to be deposited in the vaginal epithelium. During these times, the anaerobic metabolism of the glycogen, by the epithelial cells themselves and/or by vaginal flora, causes the vagina to become acidic (pH similar to 4). This study was designed to test whether the characteristics of acid production by vaginal flora in vitro can account for vaginal acidity. Eight vaginal Lactobacillus isolates from four species-L. gasseri, L. vaginalis, L. crispatus, and L. jensenii-acidified their growth medium to an asymptotic pH (3.2 to 4.8) that matches the range seen in the Lactobacillus-dominated human vagina (pH 3.6 to 4.5 in most women) (B. Andersch, L. Forssman, K, Lincoln, and P. Torstensson, Gynecol. Obstet. Investig. 21:19-25, 1986; L. Cohen, Br. J. Vener. Dis. 45:241-246, 1969; J. Paavonen, Scand. J. Infect. Dis. Suppl. 40:31-35, 1983; C. Tevi-Benissan, L. Belec, M. Levy V. Schneider-Fauveau, A. Si Mohamed, M.-C. Hallouin, M. Matta, and G. Gresenguet, Clin. Diagn. Lab. Immunol. 4:367-374, 1997). During exponential growth, all of these Lactobacillus species acidified their growth medium at rates on the order of 10(6) protons/bacterium/s. Such rates, combined with an estimate of the total number of lactobacilli in the vagina, suggest that vaginal lactobacilli could reacidify the vagina at the rate observed postcoitally following neutralization by the male ejaculate (W. H. Masters and V. E. Johnson, Human sexual response, p. 93, 1966). During bacterial vaginosis (BV), there is a loss of vaginal acidity, and the vaginal pH rises to >4.5. This correlates with a loss of lactobacilli and an overgrowth of diverse bacteria. Three BV-associated bacteria, Gardnerella vaginalis, Prevotella bivia, and Peptostreptococcus anaerobius, acidified their growth medium to an asymptotic pH (4.7 to 6.0) consistent with the characteristic elevated vaginal pH associated with BV. Together, these observations are consistent with vaginal Bore, rather than epithelial cells, playing a primary role in creating the acidity of the vagina.
Objectives:
The primary objective of this study was to evaluate the correlation among symptoms, signs, and the number of lactobacilli in postmenopausal vaginal atrophy. The secondary objective was to develop a new parameter to improve the correlation.
Study design:
A cross-sectional descriptive study.
Methods:
Naturally postmenopausal women aged 45-70 years with at least one clinical symptom of vaginal atrophy of moderate to severe intensity were included in this study. All of the objective parameters (vaginal atrophy score, vaginal pH, the number of lactobacilli, vaginal maturation index, and vaginal maturation value) were evaluated and correlated with vaginal atrophy symptoms. A new parameter of vaginal atrophy, vaginal atrophy symptoms II, was developed and consists of the two most bothersome symptoms (vaginal dryness and dyspareunia). Vaginal atrophy symptoms II was analyzed for correlation with the objective parameters.
Results:
A total of 132 naturally postmenopausal women were recruited for analysis. Vaginal pH was the only objective parameter found to have a weak correlation with vaginal atrophy symptoms (r = 0.273, p = 0.002). The newly developed vaginal atrophy symptoms II parameter showed moderate correlation with vaginal pH (r = 0.356, p < 0.001) and a weak correlation with the vaginal atrophy score (r = 0.230, p < 0.001). History of sexual intercourse within 3 months was associated with a better correlation between vaginal atrophy symptoms and the objective parameters.
Conclusion:
Vaginal pH was significantly correlated with vaginal atrophy symptoms. The newly developed vaginal atrophy symptoms II was associated with a better correlation. The vaginal atrophy symptoms II and vaginal pH may be better tools for clinical evaluation and future study of the vaginal ecosystem.
Objective: To determine the prevalence of stress, urge, and mixed urinary incontinence and associated risk factors in postmenopausal women. Methods: Before enrollment in a 4-year, randomized trial of combination hormone therapy to prevent coronary heart disease, 2763 participants completed questionnaires on prevalence and type of incontinence. We measured factors potentially associated with incontinence including demographics, reproductive and medical histories, height, weight, and waist-to-hip circumference ratio. We used multivariate logistic models to determine independent associations between those factors and weekly incontinence by type. Results: The mean (+/- standard deviation [SD]) age of the participants was 67 +/- 7 years; 89% were white and 8% were black. Fifty-six percent reported weekly incontinence. In multivariate analyses, the prevalence of weekly stress incontinence was higher in white than black women (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.6, 5.1), in women with higher body-mass index (BMI) (OR 1.1 per 5 units, 95% CI 1.0, 1.3), and higher waist-to-hip ratio (OR 1.2 per 0.1 unit, 95% CI 1.0, 1.4). The prevalence of weekly urge incontinence was higher in older women (OR 1.2 per 5 years, 95% CI 1.1, 1.3), diabetic women (OR 1.5, 95% CI 1.1, 2.0) and women who had reported two or more urinary tract infections in the prior year (OR 2.0, 95% CI 1.1, 3.6). Conclusion: Stress and urge incontinence are common in postmenopausal women and have different risk factors, suggesting that approaches to risk-factor modification and prevention also might differ and should be specific to types of incontinence. (C) 1999 by The American College of Obstetricians and Gynecologists.