Helping doctors utilize the prostate-specific antigen effectively: an online randomized controlled trial (The DUPE trial)

2012 ◽  
Vol 82 (9) ◽  
pp. 633-638 ◽  
Author(s):  
Sam S. Farah ◽  
Matthew Winter ◽  
Sree Appu
Keyword(s):  
Randomized Controlled Trial ◽  
Prostate Specific Antigen ◽  
Controlled Trial ◽  
Specific Antigen ◽  
Randomized Controlled

scholarly journals The safety and efficacy of irreversible electroporation versus tamsulosin in the treatment of benign prostatic obstruction: study protocol and rationale for a randomized controlled trial

2019 ◽  
Author(s):  
Qi-Xiang Song ◽  
Biming He ◽  
Xu Gao ◽  
Chuanliang Xu ◽  
Yinghao Sun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Day Treatment ◽  
Controlled Trial ◽  
Standard Procedure ◽  
Irreversible Electroporation ◽  
Specific Antigen ◽  
Benign Prostatic Obstruction ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Patient Reported

Abstract Background Though transurethral resection of the prostate is still considered to be the ‘‘gold standard’’ procedure for benign prostatic obstruction (BPO), the reported post-operative complication rate is not uncommon. The emerging of minimally invasive focal ablative therapies provide an alternative option for patients who are dissatisfied with medical treatment yet do not willing to take the interventional procedures. Irreversible electroporation (IRE) is a novel focal therapy which can accurately ablate the target tissues with minimum damage to the surrounding structures. The application of IRE in selected patients with prostate cancer has yielded promising results, but no report on BPO has been published. Methods/design This is a single-centered, prospective, randomized controlled trial to evaluate the effectiveness and safety of IRE in treating BPO compare with tamsulosin. We aim to recruit BPO patients who are currently taking tamsulosin but without absolute indications for surgical intervention. Eligible subjects will undergo a 3-day treatment free washout period, followed by baseline assessment. After randomized into IRE group and tamsulosin (0.2mg orally once daily) group, subjects will be followed-up for up to 24 months. The primary clinical outcome is the change in maximum flow rate from baseline at 6 months. Other assessments, including symptom questionnaires, ultrasound, prostatic specific antigen, prostate magnetic resonance image and pressure-flow study, will be carried out at different time points during follow-up. Any perception or patient-reported adverse events in both treatment arms will be documented. Data will be analyzed by a specialist who is blinded to the medical status and treatment modality in order to minimize the potential bias. Discussion This is the first randomized controlled trial evaluating the feasibility of IRE for the treatment of BPO. The outcomes of this study will provide high level of evidence to determine its true clinical value.

scholarly journals Testosterone Replacement in Older Hypogonadal Men: A 12-Month Randomized Controlled Trial

1997 ◽  
Vol 82 (6) ◽  
pp. 1661-1667 ◽  
Author(s):  
Rahmawati Sih ◽  
John E. Morley ◽  
Fran E. Kaiser ◽  
Horace M. Perry ◽  
Ping Patrick ◽  
...  
Keyword(s):  
Grip Strength ◽  
Prostate Specific Antigen ◽  
Controlled Trial ◽  
Specific Antigen ◽  
Older Men ◽  
Control Group ◽  
Randomized Controlled ◽  
Testosterone Administration ◽  
Potential Risks ◽  
To Receive

Abstract A decline in testicular function is recognized as a common occurrence in older men. However data are sparse regarding the effects of hypogonadism on age-associated physical and cognitive declines. This study was undertaken to examine the year-long effects of testosterone administration in this patient population. Fifteen hypogonadal men (mean age 68 ± 6 yr) were randomly assigned to receive a placebo, and 17 hypogonadal men (mean age 65± 7 yr) were randomly assigned to receive testosterone. Hypogonadism was defined as a bioavailable testosterone <60 ng/dL. The men received injections of placebo or 200 mg testosterone cypionate biweekly for 12 months. The main outcomes measured included grip strength, hemoglobin, prostate-specific antigen, leptin, and memory. Testosterone improved bilateral grip strength (P < 0.05 by ANOVA) and increased hemoglobin (P < 0.001 by ANOVA). The men assigned to testosterone had greater decreases in leptin than those assigned to the control group (mean ± sem: −2.0 ± 0.9 ng/dL vs. 0.8 ± 0.7 ng/dL; P < 0.02). There were no significant changes in prostate-specific antigen or memory. Three subjects receiving placebo and seven subjects receiving testosterone withdrew from the study. Three of those seven withdrew because of an abnormal elevation in hematocrit. Testosterone supplementation improved strength, increased hemoglobin, and lowered leptin levels in older hypogonadal men. Testosterone may have a role in the treatment of frailty in males with hypogonadism; however, older men receiving testosterone must be carefully monitored because of its potential risks.

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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