scholarly journals A clinical trial comparing BiVap (Richard Wolf®) saline vaporization of the prostate vs. TwisterTM Diode Laser System in the treatment of benign prostatic obstruction between prostate volume 90 to 150 ml

2021 ◽  
pp. 003693302110722
Author(s):  
Ayhan Karakose ◽  
Yasin Yitgin

Introduction To evaluate the efficacy, safety and postoperative outcomes of the BiVap and Twister systems with benign prostatic obstruction (BPO) in prostate volüm between 90–150 ml. Methods In total, we included 131 patients treated with BiVap system (n = 68) and Twister system (n = 63). Postoperative complications including urinary tract infection, transient hematuria, severe dysuria and fever >38° C, urinary incontinence and urethral stricture were also noted. All patients were evaluated at the postoperative 1st, 3rd, 6th and 12th month and preoperative and postoperative values of IPSS score, QoL score, total PSA, IIEF 15, PVR, Qmax and Qave were compared. Results Preoperative demographic characteristics were similar in the 2 groups. There was observed significant improvement for IPSS, Qmax, Qave, PVR, and QoL score by the postoperative first month compared to the preoperative values in both groups. Maximum improvement in the IPSS, Qmax, Qave, QoL score and PVR were achieved at postoperative 6, 3, 12, 3 and 12th months respectively in group 1. In group 2 maximum improvement in the same parameters were achieved at postoperative 6, 3, 6, 6 and 12th months, respectively. Conclusions BiVap and Twister systems are safe, effective, and useful technique, which can be used in the surgical treatment of BPO between 90–150 ml.

Author(s):  
Ayhan Karaköse ◽  
Yasin Yitgin

Introduction:To evaluate the efficacy, safety and postoperative outcomes of the BiVap saline vaporization and Twister™ Diode Laser systems with benign prostatic obstruction (BPO) in prostate volüm between 90-150 ml. Methods:In total, we included 131 patients treated with BiVap system (n=68) and Twister system (n=63). Postoperative complications including urinary tract infection, transient hematuria, severe dysuria and fever >38° C, urinary incontinence and urethral stricture were also noted. All patients were evaluated at the postoperative 1st, 3rd, 6th and 12th month and preoperative and postoperative values of IPSS score, QoL score, total PSA, IIEF 15, PVR, Qmax and Qave were compared. Statistical analyses were performed with SPSS version 18. A P-value<0.05 was considered significant. Results:Preoperative demographic characteristics were similar in the 2 groups. There was observed significant improvement for IPSS, Qmax, Qave, PVR, and QoL score by the postoperative first month compared to the preoperative values in both groups. Maximum improvement in the IPSS, Qmax, Qave, QoL score and PVR were achieved at postoperative 6, 3, 12, 3 and 12th months respectively in group 1. In group 2 maximum improvement in the IPSS, Qmax, Qave, QoL score and PVR were achieved at postoperative 6, 3, 6, 6 and 12th months, respectively. There was no significant difference between the two groups in terms of IPSS, Qmax, Qave, QoL score, PSA, PVR, IIEF-EF and IIEF-OS during the 1 year follow-up period postoperatively. Conclusions:BiVap and Twister systems are safe, effective, and useful technique, which can be used in the surgical treatment of BPO between 90-150ml.


2019 ◽  
Vol 6 (1) ◽  
pp. e000264 ◽  
Author(s):  
Marcus Klawitter ◽  
Dörte Döpfer ◽  
Theo Broderick Braden ◽  
Ermias Amene ◽  
Kerstin Elisabeth Mueller

Objectives and designThis trial evaluated the effect of bandaging of acute painful ulcerative bovine digital dermatitis (DD) lesion (stage M2) in dairy cows, tested using two different topical treatments.DesignRandomised clinical trial.SettingThis study was conducted using Holstein-Friesian cows ranging in age from heifers to fourth lactation in a single dairy herd and diagnosed with acute ulcerative DD lesions (stage M2) on the first examination (week 0). Cows were randomly assigned into either a non-bandaged or bandaged group across two treatment conditions: topical chlortetracycline spray (CTC) and Intra Hoof-Fit Gel (IHF). Lesions received standardised bandaging and treatment on a weekly basis. Unhealed lesions could receive up to five repeated treatments, at weekly intervals, within a four-week period. Both M-stage and locomotion were also evaluated and scored weekly. Cows with healthily formed skin (stage M0) were deemed healed and subsequently released from the study.ResultsIn total, 163 M2 lesions were diagnosed at week 0. Bandaged M2 lesions had a significantly higher probability of cure than non-bandaged lesions regardless of treatment type (HR: 4.1; P<0.001; 95 per cent CI: 2.5 to 6.8). Most healing occurred within the first three weeks of trial. Furthermore, bandaged lesions (group 2 and group 4) were significantly less likely to progress into the chronic hyperkeratotic or proliferative stage (M4) than non-bandaged lesions in group 1 and group 3 (HR: 0.10; P<0.001; 95 per cent CI: 0.04 to 0.22). Out of concern for the cow’s wellbeing, this study investigated the effects of bandaging on locomotion. Bandaging had no effect on locomotion for either cows treated with CTC (group 1: median Sprecher score, 2; IQR=1–2; group 2: median Sprecher score, 2; IQR=1–3; P=0.3) or IHF (group 3: median Sprecher score, 2; IQR=1–2; group 4: median Sprecher score, 2; IQR=1–3; P=0.3).


Pathogens ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. 205 ◽  
Author(s):  
Michel Mandro ◽  
Joseph Nelson Siewe Fodjo ◽  
Alfred Dusabimana ◽  
Deby Mukendi ◽  
Steven Haesendonckx ◽  
...  

Background: There is anecdotal evidence that ivermectin may decrease seizure frequency in Onchocerca volvulus-infected persons with epilepsy (PWE). Methods: In October 2017, a 12-month clinical trial was initiated in rural Democratic Republic of Congo. PWE with onchocerciasis-associated epilepsy experiencing ≥2 seizures/month were randomly allocated to receive, over a one-year period, ivermectin once or thrice (group 1), while other onchocerciasis-infected PWE (OIPWE) were randomized to ivermectin twice or thrice (group 2). All participants also received anti-epileptic drugs. Data was analyzed using multiple logistic regression. Results: We enrolled 197 participants. In an intent-to-treat analysis (data from group 1 and 2 combined), seizure freedom was more likely among OIPWE treated with ivermectin thrice (OR: 5.087, 95% CI: 1.378–19.749; p = 0.018) and twice (OR: 2.471, 95% CI: 0.944–6.769; p = 0.075) than in those treated once. Similarly, >50% seizure reduction was more likely among those treated with ivermectin twice (OR: 4.469, 95% CI: 1.250–16.620) and thrice (OR: 2.693, 95% CI: 1.077–6.998). Absence of microfilariae during the last 4 months increased the odds of seizure freedom (p = 0.027). Conclusions: Increasing the number of ivermectin treatments was found to suppress both microfilarial density and seizure frequency in OIPWE, suggesting that O. volvulus infection plays an etiological role in causing seizures.


2017 ◽  
Vol 9 ◽  
pp. 176 ◽  
Author(s):  
Diah Ayu Maharani ◽  
Alia Ramadhani ◽  
Melissa Adiatman ◽  
Yuniardini Septorini Wimardhani ◽  
Linda Kusdhany ◽  
...  

Objective: This study aimed at comparing the antiplaque, anticalculus, and antigingivitis potentials of a mouth rinse containing essential oil, alcohol,zinc, and fluoride with a mouth rinse containing cetylpyridinium chloride (CPC) 0.1% over 1-, 2-, and 3-month periods.Methods: This study was a double-blind, parallel randomized clinical trial with a 3-day run-in phase. Respondents were asked to gargle twice dailywith 15 ml of mouth rinse for 30 seconds after brushing teeth. Respondents were 80 females with a mean age of 21 years, and a single dental examinerwas employed throughout the study to decrease the variance. Prophylaxis was performed for all respondents before the intervention. Three mouthrinses were tested: Group 1 with the mouth rinse containing CPC 0.1%, Group 2 as the negative control, and Group 3 as the positive control with amouth rinse containing alcohol. Evaluations were conducted by plaque index, gingival index, calculus index, and CariScreen examinations.Results: The clinical trial showed that the mouth rinse with alcohol and the mouth rinse containing CPC 0.1% were effective in inhibiting bacterialbuildup (antiplaque) and have anticalculus properties, but with no statistically significant antigingivitis effect.Conclusion: It was found that the mouth rinse containing alcohol has similar effectiveness with CPC 0.1% mouth rinse, but side effects, such as aburning sensation, were reported in the alcohol-containing mouth rinse.


2015 ◽  
Vol 25 (2) ◽  
pp. 288-295 ◽  
Author(s):  
Koji Nakamura ◽  
Kenjiro Sawada ◽  
Michiyo Sugiyama ◽  
Seiji Mabuchi ◽  
Takeshi Hisamatsu ◽  
...  

ObjectiveRemoval of the ovaries is common during surgery for endometrial cancer. However, because loss of the ovaries can cause several health problems in patients, strategies for the prevention of such problems need to be established. Hence, we decided to conduct a multicenter randomized clinical trial to assess the effect of raloxifene on bone mineral density (BMD), bone metabolism, and the lipid profile of patients who had undergone surgery for patients with endometrial cancer.Materials and MethodsPatients with endometrial cancer were enrolled after treatment. The participants were randomized into 2 groups: group 1 included 39 women who received alfacalcidol (1 μg/d) alone and group 2 included 37 women who received alfacalcidol and the test drug, raloxifene hydrochloride, at a dose of 60 mg/d. The BMD of lumbar spine and femoral neck, serum bone markers, as well as lipid profile parameters were evaluated at enrollment as well as 6, 12, and 24 months after the enrollment. The primary efficacy end point was the percentage change from baseline to 24 months in lumbar spine (L2-L4) and femoral neck BMD.ResultsSixty-four women completed the 24-month study. At 24 months, the lumbar and femoral neck BMDs were significantly increased in group 2 compared with group 1 (3.5% vs −0.8% and 2.3% vs −2.8%, respectively). In group 2, low-density lipoprotein-cholesterol levels were significantly reduced by 13.6% and serum N-terminal telopeptide of type I collagen as well as bone-specific alkaline phosphatase values were significantly reduced by 16.7% and 25.7%, respectively. The patients who received adjuvant therapy for endometrial cancer showed a significantly higher response to raloxifene (5.8% vs 1.9%). Recurrence was detected in 2 (2.6%) patients in group 1. No severe adverse events were noted in any patient during the study period.ConclusionsRaloxifene exerts positive effects on BMD, bone metabolism, and lipid profile parameters and could provide an improved therapeutic option for patients with endometrial cancer.


2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Andri M. T. Lubis ◽  
Rangga B. V. Rawung ◽  
Aida R. Tantri

Acute pain is the most common early complication after total knee arthroplasty causing delayed mobilization and increased demands of morphine, leading to higher operative cost. Several studies have assessed the effectiveness, side-effects, and ease of use of various analgesics. Preemptive analgesia with combined celecoxib and pregabalin has been reported to yield positive outcomes. In this randomized, double-blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. Group 1 was given celecoxib 400mg and pregabalin 150mg 1 hour before the operation, Group 2 was given celecoxib 200mg and pregabalin 75mg twice daily starting from 3 days before the operation, and Group 3 was given a placebo. The outcome was measured with Visual Analog Scale, knee range of motion, and postoperative mobilization. There was a significant difference in postoperative morphine usage between the groups that were administered with preemptive analgesia and the placebo group, but no significant difference was found between Group 1 and Group 2 that were given preemptive analgesia at different doses. ROM and postoperative mobilization were not significantly different among the three groups. Two patients in the first group, one patient in the second group, and one patient in the third group developed nausea. Preemptive analgesia is proven to reduce postoperative usage of morphine independent of the dosage. We recommend the use of combined celecoxib and pregabalin as preemptive analgesia after the total knee arthroplasty procedure. This trial is registered with NCT03523832 (ClinicalTrials.gov).


Author(s):  
A. A. Zvyagin ◽  
V. S. Demidova ◽  
G. V. Smirnov

The article presents the results of a prospective, single-center observational clinical trial, in which biomarker levels were compared in patients with sepsis.Objective: to evaluate the dynamics of the level of presepsin, procalciotonin and C-reactive protein in two groups - the dead and the surviving patients with sepsis.Materials and methods. The study consistently included 41 patients with a diagnosis of sepsis (based on the concept of "Sepsis-3"), divided into two groups: group 1 (21 people) – survivors, group 2 (20 people) – dead. Patients in both groups received conventional intensive therapy for sepsis. In addition to the standard laboratory and instrumental examination, patients in the dynamics were monitored for the level of presepsin, procalcitonin, C-reactive protein.Results. The average level of presepsin in group 1 and group 2 was 1718.00 and 3266.50 pg/ml, respectively, with half of the values being within (Me (25.75) 1021.00–3231.00 and 1618.50–7469.00 pg/ml. The average level of procalcitonin in group 1 and group – 0.995 and 4.465 ng/ml, respectively, while Me (25.75) 0.49–4.44 and 1.625–19.30 ng/ml. The average level of C-reactive protein in group No. 1 and group No. 2 is 95.5 and 215.0 mg/l, respectively, with Me (25.75) 64.00–155.00 and 155.00–264.00 mg/l. When comparing the values of biomarkers in the two groups of patients, significant differences were found (p-value for presepsin, procalсitonina and C-reactive protein are, respectively 0.000008, 0.000242, 0.0000001).


2020 ◽  
Author(s):  
Huan Liu ◽  
Jun Jin ◽  
Qiao Chen ◽  
Zhongmin Li

Abstract BackgroundThe incidence of thyroid nodules increased significantly, but the mortality rate of thyroid cancer remained stable or even decreased. However, surgical treatment of thyroid nodules is more aggressive, including the number and scope of surgery. the purpose of our study was to evaluate whether unilateral thyroid nodules affect the malignancy risk of contralateral thyroid nodules. Methods We conducted a retrospective study on all patients with thyroid nodules in a tertiary hospital within one year. Unilateral and bilateral thyroid nodules were the control group and the experimental group, respectively. Based on the TI-RADS grades, the experimental group and the control group were divided into two subgroups. We used chi-square test or Fisher's exact test to evaluate whether there were statistical differences in the incidence and pathological types of thyroid cancer between the experimental group and the control group. Results Our study showed that there was no significant difference in malignant risk between the experimental group 1 and the control group 1, and the experimental group 2 and the control group 2 (20%vs35%, p=0.724, 63.16%vs76.32%, p=0.297, respectively). Both the a-side thyroid of the experimental group and the control group were papillary thyroid carcinoma, including micropapillary thyroid carcinoma, and there was no difference in the proportion of micropapillary thyroid carcinoma (p = 0.200, 0.620, respectively). Conclusions There is no evidence that bilateral thyroid nodules affect each other in terms of malignant risk, that is, in bilateral thyroid nodules, unilateral thyroid cancer does not change the malignant risk of contralateral thyroid nodules.This study has been registered with the Chinese Clinical Trial Registry, clinical trial registration number: ChiCTR2000038611, registration time: 2020-09-26.


2019 ◽  
Vol 13 (3) ◽  
pp. 183-191
Author(s):  
Prerna Y. Shirke ◽  
Abhay P. Kolte ◽  
Rajashri A. Kolte ◽  
Pranjali V. Bawanakar

Background. Atorvastatin (ATV), which belongs to the statin class of drugs, is the formidable inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. This clinical trial evaluated and compared the clinical and radiographic changes in chronic periodontitis (CP) patients, obtained through 1.2% ATV as an adjunct to scaling and root planing (SRP) in the treat-ment of intraosseous defects. Methods. Twenty CP patients, with a minimum of one pair of bilateral intraosseous, were randomly selected for this split-mouth study. Group 1 included 20 sites treated with SRP and subgingival delivery of a placebo gel, whereas an equal number of sites in group 2 were treated by SRP along with subgingival delivery of 1.2% ATV gel. The plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD) and clinical attachment level (CAL) were evaluated at baseline and 3- and 6-month intervals, while the intraosseous defect was assessed at baseline and 6-month interval using cone-beam computed tomography (CBCT). Paired t-test was used to determine statistical significance. Results. A greater reduction in the mean PPD and gain in CAL was found in group 2 compared to group 1 at 3- and 6-month intervals. Furthermore, a significantly greater bone fill was obtained in group 2 (1.70±0.54 mm) compared to group 1 (0.22±0.43 mm) after six months.Conclusion. ATV, as an adjunct to SRP, enhanced periodontal regeneration, as a noninvasive way to treat periodontal in-traosseous defects.


1970 ◽  
Vol 2 (1) ◽  
pp. 29-34 ◽  
Author(s):  
Nupur Thakur ◽  
Geeta Gurung ◽  
Ashma Rana

Aim: To determine whether short term bladder catheterisation for 24 hrs after vaginal hysterectomy for prolapse would be more advantageous to routinely practiced 3 days catheterisation. Method: Randomized comparative study was done as thesis topic in Gynaecological Ward of TU Teaching Hospital, Maharajgunj, Kathmandu from 30th October 2004 to 2nd November 2005. A total of 100 women were included in this study. Prior to surgery at OT table, and before giving prophylactic antibiotics urine samples were collected from metal catheter for routine analysis. They were randomized into two groups. In groups 1 (n=50) transurethral catheter was removed after 24 hrs of surgery. In group 2 (n=50) catheter was removed on 3rd post operative day. Urine culture was taken before removal of the catheter. Residual volume of urine after the first voiding was measured by transabdominal ultrasound. Recatheterisation for three more days was considered whenever residual volume exceeded 200ml. Result: Recatheterisation was not needed in either groups for residual volume >200ml. Regarding recatheterisation 4 needed them after 2-3 hrs of first voiding. Among these 4 women, cause of urinary retention was accountable for pelvic haematoma leading to pelvic abscess in one case, which belonged to group 1 where as urinary tract infection was responsible for urinary retention in group 2. There were no explainable causes in two cases. But urinary tract infection was seen in two cases in group 1 and 11 cases in group 2 (P value 0.017). Conclusion: This study has shown that short term catheterisation is more beneficial in terms of lower incidence of urinary tract infection (2 Vs 11) and related febrile morbidity as compared to long term catheterisation. Key words: Uterovaginal prolapse, pelvic floor repair with vaginal hysterectomy, catheterisation.   doi:10.3126/njog.v2i1.1473 N. J. Obstet. Gynaecol Vol. 2, No. 1, p. 29 - 34 May -June 2007


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