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Prostatic Hyperplasia clinical trials

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NCT ID: NCT01342562 Completed - Clinical trials for Benign Prostatic Hypertrophy

The Effects of Intrathecal Dexmedetomidine on Spinal Anesthesia Using Diluted Low-Dose Bupivacaine for Transurethral Resection of Prostate in Elderly

Start date: November 2010
Phase: N/A
Study type: Interventional

Spinal block is the most common anesthetic technique for transurethral resection of prostatectomy (TURP). Most patients undergoing TURP are elderly and frequently present with cardiopulmonary and endocrine diseases. Low-dose local anesthetic is commonly administer to limit the block level to minimize the hemodynamic changes. However, sometimes it may not provide an adequate level of sensory block. Thus, intrathecal additive is frequently administer with local anesthetic to improve analgesic effect. Dexmedetomidine(DXM), a selective 2-adrenoreceptor agonist, has been used in the epidural space in humans without any reports of neurological deficits. Previous clinical studies showed that intravenous dexmedetomidine administration prolonged the sensory and motor blocks of bupivacaine spinal analgesia. But clinical studies about the use of intrathecal DXM with local anesthesia in humans are scarce in the literature. Kanazi et al. found that 3μg DXM added to 12 mg spinal bupivacaine produced the significant short onset of sensory and motor block as well as significantly longer duration of sensory and motor block than bupivacaine. And Al-Mustafa et al. reported that intrathecal dexmedetomidine as an adjuvant to 12.5mg bupivacaine in spinal anesthesia has a dose dependant effect on the onset and regression of sensory and motor block. In our previous study, low-dose diluted bupivacaine 5 mg provided sufficient anesthetic level when opioid was added with local anesthetic. However, opioid-induced side effects, such as pruritus, nausea, or vomiting, could be an obstacle in common use. The aim of this study is to evaluate whether DXM-low-dose bupivacaine spinal anesthesia can provide the effective spinal anesthesia and postoperative analgesia with minimal side effect compare to the local anesthetic only group. This study was conducted in a randomized, double-blind, controlled fashion. Patients were randomly allocated to DXM group or Saline group. DMT group received hyperbaric bupivacaine 0.5% (1.2 ml) (6 mg) in dextrose 8% solution + DMT 0.3 ml (3 µg)-in total, bupivacaine 0.4% (1.5 ml) intrathecally and Saline group received hyperbaric bupivacaine 0.5% (1.2 ml) (6 mg) in dextrose 8% solution + normal saline 0.3 ml -in total, bupivacaine 0.4% (1.5 ml) intrathecally. After spinal block, the level of sensory block, defined as the dermatomal segment with loss of pain sensation to pin-prick with a 22 G hypodermic needle and cold sensation to alcohol swab was measured every 2 min after intrathecal injection. The investigators recorded the peak sensory block level, time to peak block level from intrathecal injection, blood pressure and heart rate, and analgesic supplementation during operation. The maximum motor block level was assessed according to the modified Bromage scale. During postoperative period, the frequency of analgesic requirement, time to the first analgesic request, and pain scores were evaluated by blind investigator.

NCT ID: NCT01337258 Completed - Cancer Clinical Trials

Economic Analyses of the REDUCE Trial

Start date: January 2010
Phase: N/A
Study type: Observational

The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical trial of the use of dutasteride compared with no chemopreventive treatment. The REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.

NCT ID: NCT01334723 Completed - Clinical trials for Prostatic Hyperplasia

Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

Start date: April 2010
Phase: N/A
Study type: Observational

This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).

NCT ID: NCT01332487 Completed - Clinical trials for Prostatic Hyperplasia

Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

Start date: August 2010
Phase: N/A
Study type: Observational

This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).

NCT ID: NCT01332435 Completed - Clinical trials for Prostatic Hyperplasia

Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

Start date: November 2009
Phase: N/A
Study type: Observational

This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).

NCT ID: NCT01330927 Completed - Nocturia Clinical Trials

Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to establish the dose response relationship of VA106483 and nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic Hypertrophy (BPH) who are likely to present with nocturia.

NCT ID: NCT01330303 Completed - Healthy Volunteers Clinical Trials

SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin

Start date: December 2009
Phase: Phase 1
Study type: Interventional

It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions.

NCT ID: NCT01323998 Completed - Clinical trials for Prostatic Hyperplasia

Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

Start date: April 2010
Phase: N/A
Study type: Observational

This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008)

NCT ID: NCT01314456 Not yet recruiting - Prostate Cancer Clinical Trials

3D Recording of a Trans-rectal Prostate Biopsy

Start date: March 2011
Phase: N/A
Study type: Interventional

Prostate biopsy is performed by multiple consecutive biopsy needle insertion into the prostate gland under a trans-rectal ultrasound probe guidance. Today, the performing physician navigates the needle using a momentary 2D ultrasound image (longitudinal and transverse B mode) without any record of the full prostate boundaries or previous biopsies' location. This study's Objectives are to record the trans-rectal biopsy procedure including the initial scan and the needle biopsy location and to modulate a 3D model of the prostate with accurate display the locations of the various biopsies taken during the procedure.

NCT ID: NCT01301599 Completed - Clinical trials for Benign Prostatic Hyperplasia

Comparison Between Alpha Blocker Monotherapy and 5ARI Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia (BPH)

Start date: January 2011
Phase: Phase 4
Study type: Interventional

This study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia.