The panty condom: a pilot study of the function and acceptability of an alternative female condom design

2019 ◽  
Vol 30 (11) ◽  
pp. 1080-1086 ◽  
Author(s):  
Mags Beksinska ◽  
Jennifer Smit ◽  
Nonhlanhla Mphili ◽  
Ross Greener ◽  
Virginia Maphumulo
Keyword(s):  
South Africa ◽  
Pilot Study ◽  
Failure Mode ◽  
Lower Cost ◽  
Female Condom ◽  
Clinical Failure ◽  
Primary Endpoints ◽  
Total Female ◽  
The Mean

New female condom (FC) products, different in design and materials that have the potential to lower cost and improve acceptability are being developed. A pilot study of the Panty Condom was conducted among experienced FC users in Durban, South Africa. This pilot function trial enrolled 19 women who were asked to use five Panty Condoms each and collect information on use in a condom diary at home, followed by one follow-up interview. Primary endpoints were total clinical failure and total female condom failure. Non-inferiority of component modes, clinical breakage, non-clinical breakage, slippage, misdirection, and invagination were also determined. Frequencies and percentages were calculated for each failure mode. The mean age of the participants was 27.8 years (SD 4.9). Safety and acceptability data were also assessed. In 95 condom uses nine failure events occurred in eight condoms. Clinical breakage occurred in 8.4% (n = 8) of condoms and slippage in one condom. Total FC failure was 8.4% of all condom uses. Of the eight breakage events there were two reports of the condom ripping during sex and six reports of the condom detaching from the panty. Fifteen women either liked very much or liked somewhat using the Panty Condom. Total clinical failure was approximately twice that seen in other FC functionality studies.

scholarly journals Transpalpebral Electrical Stimulation as a Novel Therapeutic Approach to Decrease Intraocular Pressure for Open-Angle Glaucoma: A Pilot Study

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Félix Gil-Carrasco ◽  
Daniel Ochoa-Contreras ◽  
Marco A. Torres ◽  
Jorge Santiago-Amaya ◽  
Fidel W. Pérez-Tovar ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Intraocular Pressure ◽  
Pilot Study ◽  
Open Angle Glaucoma ◽  
Constant Current ◽  
Open Angle ◽  
Naive Group ◽  
Treatment Naïve ◽  
The Mean

Purpose. To determine the effect on intraocular pressure of transpalpebral specific exogenous voltages in a cohort of open-angle glaucoma patients. Methods. This is a prospective, comparative, and experimental pilot study. The electrical stimuli applied consisted of 10 Hz, biphasic, nonrectangular current pulses (100 μA) delivered from an isolated constant current stimulator. At intake, baseline IOP measurements were obtained from each eye. The measurement was repeated before and after microstimulation until the end of the treatment. Results. Seventy-eight eyes of 46 patients diagnosed with POAG were studied: 58 eyes with maximum tolerated medical treatment and 20 eyes without treatment (naïve). The mean baseline IOP on the treated POAG group was 19.25 mmHg ± 4.71. Baseline IOP on the naïve group was 20.38 mmHg ± 3.28. At the four-month follow-up visit, the mean IOP value on the treatment group was 14.41 mmHg ± 2.06 (P<0.0001). The obtained mean IOP measurement on the treatment-naïve group was 15.29 mmHg ± 2.28 (P<0.0001). Conclusions. The hypotensive response obtained using transpalpebral electrical stimulation on POAG patients, both on treatment-naïve patients and on patients receiving maximum tolerable treatment, was statistically significant when comparing basal IOP measurements to those obtained at the four-month follow-up visit.

Drop in relapse rate of MS by combination therapy of three different phosphodiesterase inhibitors

2000 ◽  
Vol 6 (1) ◽  
pp. 56-58 ◽  
Author(s):  
Akio Suzumura ◽  
Takuya Nakamuro ◽  
Tsukasa Tamaru ◽  
Tetsuya Takayanagi
Keyword(s):  
Pilot Study ◽  
Combination Therapy ◽  
Relapse Rate ◽  
Phosphodiesterase Inhibitors ◽  
Low Concentrations ◽  
Relapsing Remitting ◽  
Experimental Demyelination ◽  
The Mean ◽  
Therapeutic Doses

Phosphodiesterase inhibitors (PDEIs), when used in combination, synergistically suppress TNFa production by various cells and also suppress experimental demyelination at very low concentrations. We conducted a pilot study to determine whether the combination of three PDEIs suppresses the relapse of MS at the usual therapeutic doses. Of the 12 relapsing remitting MS, the mean relapse rate/year dropped remarkably (from 3.08+3.32 to 0.92+1.86) after PDEI treatment. Seven out of 12 (58.3%) were relapse-free in the follow up period (499+142 days). The combination of three PDEIs can be safe and useful strategy for the future treatment of MS.

Characteristics and Outcomes of Autoimmune Hepatitis from a Tertiary Paediatric Centre, Cape Town, South Africa

2020 ◽  
Vol 66 (4) ◽  
pp. 448-457
Author(s):  
Sawsan Yassin ◽  
Ronalda De Lacy ◽  
Komala Pillay ◽  
Elizabeth Goddard
Keyword(s):  
South Africa ◽  
Autoimmune Hepatitis ◽  
Remission Rate ◽  
Significant Risk ◽  
Red Cross ◽  
Unfavourable Outcome ◽  
Ethical Approval ◽  
Autoimmune Sclerosing Cholangitis ◽  
The Mean

Abstract Objectives To describe the clinical characteristics, biochemical and histological features, outcomes and predictors of prognosis of children with autoimmune hepatitis (AIH) from a paediatric centre in South Africa. Methods Thirty-nine children diagnosed with AIH at Red Cross War Memorial Children’s Hospital between 2005 and 2015 were included. Relevant patient’s data were retrieved from the hospital’s medical records and database. Liver biopsy slides were reviewed. Ethical approval was obtained. Data were analysed using SPSS. Results Females were 29 (74%). Mean age at presentation was 7.27 ± 3.35 years and the mean follow-up was 4.5 ± 2.4 years. Jaundice was present in 97% of patients at presentation. An acute presentation was observed in 26 (67%) even though cirrhosis was detected in 22 (56%). Autoantibody screening was completed in 35 patients, 20 (57%) were AIH-1, 1 (3%) was AIH-2 and 14 (40%) were seronegative AIH. Of the 25 patients who underwent magnetic resonance cholangiography 17 (68%) had associated autoimmune sclerosing cholangitis. The remission rate was 79%. However, 11 children relapsed later. One child required liver transplantation and one demised. Seronegative and seropositive patients have comparable characteristics and outcomes. While a higher alanine transaminase (ALT) level at presentation is a significant predictor of remission, a lower ALT level and cirrhosis are significant risk factors for unfavourable outcome. Overall survival rate was 97%. Conclusion AIH responds well to therapy with excellent survival. Hence, it should be considered in any child presenting with viral screen negative hepatitis and start therapy timeously to prevent disease progression.

scholarly journals Effectiveness of pencil push up therapy in patients with convergence insufficiency: a pilot study

1970 ◽  
Vol 9 (3) ◽  
pp. 157-161
Author(s):  
K Sapkota ◽  
DK Sah ◽  
S Bhattarai ◽  
AK Sharma ◽  
JK Shrestha ◽  
...  
Keyword(s):  
Pilot Study ◽  
Prospective Study ◽  
Symptom Score ◽  
Convergence Insufficiency ◽  
Before And After ◽  
The Mean ◽  
Ocular Morbidity ◽  
Near Work ◽  
Push Up

Background: Convergence insufficiency (CI) is a common ocular morbidity encountered in clinical optometry practice. It decreases the efficacy for near work. Pencil push up therapy (PPT) is frequently used for the treatment of CI. Aim: The aim of the study was to determine the effectiveness of pencil push up exercise in convergence insufficiency patients. Methods: A hospital based interventional longitudinal prospective study was designed. All patients attending BP Koirala Lions Centre of Ophthalmic Studies (BPKLCOS), Nepal from March 1st 2008 to February 28, 2009 with symptomatic convergence insufficiency were included in this study. Near point of convergence (NPC), prism fusion vergence (PFV) and symptom score were measured with RAF ruler, prism bar and symptom questionnaire respectively before and after PPT. Results: Out of 84 patients included in the study, only 23 completed follow up check up. Among them 73% were female and 23% were male. The mean age of patients was 19.93±6.0 years and 73% of the total were students. The improvement in NPC was statistically significant after PPT (p =0.008). The average NPC at first visit was 18.58±7.46 cm while at follow up visit, it was 11±4.6 cm. The PFV and average symptom score were also improved significantly. Conclusion: PPT is beneficial for CI patients. It improves the NPC, PFV and reduces the symptom of the patients. However, the compliance of Nepalese CI patients with PPT is poor. Keywords: NPC; PFV; convergence insufficiency; pencil push up therapy. DOI: http://dx.doi.org/10.3126/hren.v9i3.5583   HR 2011; 9(3): 157-161

scholarly journals Primary vs Secondary Osteochondral Autograft Transplantation in Patients with Large Sized OLT

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0000
Author(s):  
Kwang Hwan Park ◽  
Yeokgu Hwang ◽  
Yoo Jung Park ◽  
Dong-Woo Shim ◽  
Jin Woo Lee
Keyword(s):  
Clinical Outcomes ◽  
Bivariate Analysis ◽  
Clinical Failure ◽  
Aofas Score ◽  
Marrow Stimulation ◽  
Kaplan Meier ◽  
Operation Rate ◽  
Significant Difference ◽  
The Mean

Category: Ankle, Arthroscopy, Sports Introduction/Purpose: Osteochondral autograft transplantation (OAT) for large sized osteochondral lesions of the talus (OLT) has presented promising clinical results in recent studies. However, there was no study which has compared clinical outcomes between primary OAT and secondary OAT in the large sized OLT. The purpose of this study is to compare clinical outcomes between patients receiving primary transplantation and patients receiving secondary transplantation after failure of previous marrow stimulation for large sized OLT and investigate prognostic factor affecting clinical failures. Methods: Between 2005 and 2014, 18 patients with large sized OLT (=150 mm2) underwent primary OAT as a primary surgery (primary group) and 28 patients with large sized OLT underwent secondary OAT after a failure of arthroscopic marrow stimulation (secondary group). After arthroscopic inspection and debridement for concomitant soft tissue pathologies, conventional OAT procedures were performed. Clinical outcomes were assessed using visual analog scale (VAS), American Orthopaedic Foot & Ankle Society (AOFAS) scores, Foot and Ankle Outcome Score (FAOS) and re-operation rate. Factors associated with clinical failure were evaluated using bivariate analysis and logistic regression analysis. Survival outcomes were compared using Kaplan-Meier analysis. Results: The mean follow-up time was 6.0 years (range 2.0-10.8) and the mean size of the lesion was 194.9 mm2 (range 151.7- 296.3). There was no significant difference in patients` demographics, and preoperative findings between primary and secondary groups. Postoperative VAS, AOFAS score, FAOS, and re-operation rate had no significant difference between primary and secondary groups at the last follow-up. According to bivariate analysis, significant factor associated with clinical failure was not prior marrow stimulation but more than 225 mm2 of lesion size in preoperative MRI. Logistic regression analysis revealed that preoperative AOFAS score was significant predictor of clinical failure after the OAT in this study. The survival probabilities were not significantly different between primary and secondary groups in Kaplan-Meier plots (P = .947). Conclusion: Outcomes of secondary OAT were comparable to those of primary OAT in the large sized OLT. Therefore, we suggested that symptomatic patients with large sized OLT could be initially treated by either arthroscopic marrow stimulation or OAT and if failed with marrow stimulation, secondary OAT could be considered.

scholarly journals Translating new evidence into clinical practice: a quasi-experimental controlled before–after study evaluating the effect of a novel outreach mentoring approach on knowledge, attitudes and confidence of health workers providing HIV and infant feeding counselling in South Africa

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e034770
Author(s):  
Ameena Goga ◽  
Tanya Doherty ◽  
Samuel Manda ◽  
Tshifhiwa Nkwenika ◽  
Lyn Haskins ◽  
...  
Keyword(s):  
South Africa ◽  
Infant Feeding ◽  
Health Workers ◽  
Likert Scale ◽  
Attitude Score ◽  
Score Difference ◽  
Comparison Groups ◽  
Quasi Experimental ◽  
The Mean

ObjectivesWe report the effectiveness of a mentoring approach to improve health workers’ (HWs’) knowledge, attitudes and confidence with counselling on HIV and infant feeding.DesignQuasi-experimental controlled before–after study.SettingRandomly selected primary healthcare clinics (n=24 intervention, n=12 comparison); two districts, South Africa.ParticipantsAll HWs providing infant feeding counselling in selected facilities were invited.InterventionsThree 1–2 hours, on-site workshops over 3–6 weeks.Primary outcome measuresKnowledge (22 binary questions), attitude (21 questions—5-point Likert Scale) and confidence (19 questions—3-point Likert Scale). Individual item responses were added within each of the attitude and confidence domains. The respective sums were taken to be the domain composite index and used as a dependent variable to evaluate intervention effect. Linear regression models were used to estimate the mean score difference between intervention and comparison groups postintervention, adjusting for the mean score difference between them at baseline. Analyses were adjusted for participant baseline characteristics and clustering at health facility level.ResultsIn intervention and comparison sites, respectively: 289 and 131 baseline and 253 and 114 follow-up interviews were conducted (August–December 2017). At baseline there was no difference in mean number of correctly answered knowledge questions; this differed significantly at follow-up (15.2 in comparison; 17.2 in intervention sites (p<0.001)). At follow-up, the mean attitude and confidence scores towards breast feeding were better in intervention versus comparison sites (p<0.001 and p=0.05, respectively). Controlling for confounders, interactions between time and intervention group and preintervention values, the attitude score was 5.1 points significantly higher in intervention versus comparison groups.ConclusionA participatory, low-intensity on-site mentoring approach to disseminating updated infant feeding guidelines improved HWs’ knowledge, attitudes and confidence more than standard dissemination via a circular. Further research is required to evaluate the effectiveness, feasibility and sustainability of this approach at scale.

scholarly journals Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Takao Hirano ◽  
Yuichi Toriyama ◽  
Yoshihiro Takamura ◽  
Masahiko Sugimoto ◽  
Taiji Nagaoka ◽  
...  
Keyword(s):  
Open Label ◽  
Treat And Extend ◽  
Corrected Visual Acuity ◽  
Treatment Interval ◽  
Primary Endpoints ◽  
Intravitreal Aflibercept ◽  
Injection Interval ◽  
The Mean ◽  
Treat And Extend Regimen

AbstractThis prospective, open-label, single-arm, non-randomized clinical trial, assessed the efficacy of a 2-year treat-and-extend (T&E) regimen involving intravitreal aflibercept injection (IAI), with the longest treatment interval set to 16 weeks, and adjunct focal/grid laser in diabetic macula edema (DME) patients. We examined 40 eyes (40 adults) with fovea-involving DME from 8 Japanese centers between April 2015 and February 2017. Participants received IAI with an induction period featuring monthly injections and a subsequent T&E period featuring 8–16-week injection interval, adjusted based on optical coherence tomography findings. The primary endpoints were mean changes in the best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Thirty patients (75%) completed the 2-year follow-up. The mean BCVA and CST changed from 60.5 ± 15.6 letters and 499.2 ± 105.6 µm at baseline to 66.6 ± 17.1 letters (P = 0.217) and 315.2 ± 79.0 µm (P < 0.001), respectively, after 2 years. The treatment interval was extended to 12 and 16 weeks in 6.7% and 66.7% of patients, respectively, at the end of 2 years. The T&E aflibercept regimen with the longest treatment interval set to 16 weeks, with adjunct focal/grid laser may be a rational 2-year treatment strategy for DME.

Neurodevelopmental outcome in extremely low birth weight infants in Johannesburg, South Africa

2020 ◽  
Author(s):  
Tanusha Ramdin ◽  
Yoliswa Magadla ◽  
Robin T Saggers ◽  
Aripfani Veronica Mphaphuli ◽  
Rossella M Bandini ◽  
...  
Keyword(s):  
South Africa ◽  
At Risk ◽  
Cerebral Palsy ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Subscale Score ◽  
Extremely Low Birth Weight ◽  
Low Birth Weight Infants ◽  
The Mean

Abstract Background: Improved survival in preterm infants whether due to technological progress or treatment like antenatal steroids, surfactant administration or nasal continuous positive airway pressure (NCPAP) and aggressive resuscitation have raised the question about whether the survivors would be more prone to increased morbidity and adverse neurodevelopmental disability. Methods: This was a prospective follow-up study conducted in the neonatal unit of a tertiary hospital in Johannesburg, South Africa. Bayley scales of infant and toddler development, version III, were conducted on a group of extreme low birth weight infants (ELBWI). The mean composite cognitive, language and motor sub-scales were reported. Infants were considered to be “at risk” if the composite subscale score was below 85 and “disabled” if the composite subscale score was below 70. Infants identified with cerebral palsy were also reported.Results: The mean birth weight of the study group was 858.5grams (95% CI 839.2- 877.8) and the mean gestational age was 27.5 weeks (95% CI 27.1-27.9). The majority of ELBWI enrolled in the study had at least one Bayley at a mean corrected age of 17.09 months (CI 16.04 to 18.14). The mean composite scores for cognition were 98.4 (CI 95.1-101.7), language 90.0 (CI 87.5-92.6) and motor 97.9 (CI 94.8-101.0). All mean scores fell within the normal range, but the composite language score was the lowest. The study did not diagnose cerebral palsy in any of the infants. The study found 28 (36.3%) infants to be “at risk” for neurodevelopmental delay. Significantly more males were classified as “at risk” than females (13/25 (52%) vs. 15/52 (28.8%). Late onset sepsis (sepsis18/37 (48.6%) vs. no sepsis 10/40 (25%) p=0.031) and longer duration of ventilation (median of 12 days (IQR 46) vs. median of 4.0 days (IQR 5) p=0.048) were significantly associated with an “at risk” classification. Conclusion: Rates of early neurodevelopmental impairment have altered minimally despite significant improvements in the overall survival of ELBWI. It is of paramount importance to ensure that early neurodevelopmental outcomes are accurately assessed so as to assist doctors and families in establishing a foundation for advocacy for the immediate intensive care and post discharge follow up.

scholarly journals Ratio between Height and Thickness of the Buccal Tissues: A Pilot Study on 32 Single Implants

2019 ◽  
Vol 7 (2) ◽  
pp. 40 ◽  
Author(s):  
Davide Farronato ◽  
Mattia Manfredini ◽  
Francesco Mangano ◽  
Giada Goffredo ◽  
Marco Colombo ◽  
...  
Keyword(s):  
Pilot Study ◽  
Major Axis ◽  
Significance Level ◽  
Soft Tissue Thickness ◽  
Mucosal Thickness ◽  
Bone Level ◽  
Platform Switching ◽  
The Mean ◽  
Single Crowns

Background: Previous studies have suggested that mucosal height is related to the bone level and soft tissue thickness. The purpose of this pilot study was to investigate the ratio between the height and width of the tissues around single implants with a conical connection and platform switching. Methods: All patients receiving single implants (Anyridge®, MegaGen, Gyeongbuk, South Korea) and restored with single crowns, in a three-month period, were included in this study. After a provisionalization of 12 months, precision impressions were taken and stone casts were poured for measurements. For each implant, two values were collected at the buccal site: the mucosal height (MH), calculated from the vestibular shoulder of the implant to the upper gingival margin of the supra-implant tissue; and the mucosal thickness (MT), calculated from the vestibular shoulder of the analogue to the external mucosa point perpendicular to the implant major axis. Mean, standard deviation (SD), and confidence intervals (CI 95%) for MH and MT, as well as their ratios, were calculated. Correlation between MH and MT was assessed by Pearson’s correlation coefficient, with significance level set at 0.05. Results: 32 single Anyridge® implants were eligible for this evaluation. The mean MH was 3.44 mm (±1.28), the mean MT was 3.29 (±1.46). The average of the ratio between MH and MT of the supra-implant mucosa was therefore 1:1.19 (±0.55). The relation between MH and MT was statistically significant at p ≤ 0.01 (Pearson two-tailed 95% CI). Conclusions: Our study found a constant relationship between width and height of the peri-implant mucosa. However, our results are different from those of Nozawa et al., who found a ratio of 1:1.5 between height and thickness of the peri-implant tissues. This may be determined by the different sample and follow-up period, as well as by the implants used in our study.

Short to Medium-Term Results with Two Types of Proximally Porous-Coated Long-Stemmed Femoral Components in Revision Surgery

1998 ◽  
Vol 8 (3) ◽  
pp. 121-128 ◽  
Author(s):  
E. Garcia-Cimbrelo ◽  
J. Cordero ◽  
J. Alonso-Biarge
Keyword(s):  
Revision Surgery ◽  
Bone Ingrowth ◽  
Bone Defects ◽  
Clinical Failure ◽  
Medium Term ◽  
Survivorship Analysis ◽  
Kaplan Meier ◽  
The Mean ◽  
Grade 3

Results using 30 long-stemmed femoral components in revision surgery were analyzed. There were 15 PCA (Howmedica) and 15 BIAS (Zimmer). The mean age was 50 years (range, 23 to 65 years) for the PCA group and 61 years (range, 35 to 75 years) for the BIAS group. The mean follow-up was 5.2 years (range, 2.5 to 10 years). Using the Endoklinik classification, there were 2 cases of Grade 1 bone defects, 16 cases of Grade 2, and 12 cases of Grade 3. Morcellized graft was used in 21 cases. A Kaplan-Meier survivorship analysis was carried out. The probabilities of re-revision, clinical failure, and loosening were 23%, 32% and 80% at eight years. Subsidence was very common, with means of 15mms in the PCA group and 19mms in the BIAS group. In the grafted cases, minor resorption was found in 17 cases and major resorption in 4 cases. Because of the frequency of poor results using these prostheses, due to failure to obtain bone ingrowth, even in femora with a good bone stock, we do not recommend their use in revision surgery. The results for the PCA and BIAS group were similar.

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