Dataset Information

Medical expulsive therapy for ureter stone using naftopidil: A multicenter, randomized, double-blind, and placebo-controlled trial.

ABSTRACT:

Objectives

A prospective, multicenter, randomized, double-blind, placebo-controlled trial evaluated the effects of naftopidil 75 mg for medical expulsive therapy for a single ureter stone.

Materials and methods

Patients diagnosed with a ureter stone were prescribed aceclofenac 100 mg or a combined medication of tramadol 37.5 mg and acetaminophen 325 mg. Patients then randomly received either naftopidil 75 mg or placebo. Primary endpoint was the stone passage rate at 14 days after medication.

Results

The 150 patients enrolled in 6 institutions randomly received either naftopidil (n = 75) or placebo (n = 75). The percentages of ureter stone passed spontaneously 14 days after medication was 60.9% in the naftopidil group and 53.3% in the placebo group. Stone-free rates and the total use of analgesics showed no significant differences between the two groups. Stone-free rates at 14 days after medication were decreased when maximal stone size was increased: 39.4% (? 5 mm), 15.5% (? 6 mm), and 7.0% (? 7 mm).

Conclusions

The use of naftopidil 75 mg once daily was not effective in increasing spontaneous stone passage rates or reducing analgesic use. The maximal stone size < 6 mm and the follow-up for two weeks would be appropriate for applying medical expulsive therapy to patients with a single ureter stone.

SUBMITTER: Cho SY

PROVIDER: S-EPMC5400235 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

Medical expulsive therapy for ureter stone using naftopidil: A multicenter, randomized, double-blind, and placebo-controlled trial.

Cho Sung Yong SY Na Woong W Lee Sang Wook SW Cho Min Chul MC Oh Jong Jin JJ Lee Sangchul S Park Juhyun J Ahn Soyeon S Jeong Chang Wook CW

PloS one 20170421 4

<h4>Objectives</h4>A prospective, multicenter, randomized, double-blind, placebo-controlled trial evaluated the effects of naftopidil 75 mg for medical expulsive therapy for a single ureter stone.<h4>Materials and methods</h4>Patients diagnosed with a ureter stone were prescribed aceclofenac 100 mg or a combined medication of tramadol 37.5 mg and acetaminophen 325 mg. Patients then randomly received either naftopidil 75 mg or placebo. Primary endpoint was the stone passage rate at 14 days after ...[more]

PMID: 28430785

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Project description:ObjectiveTo assess the efficacy and safety of a remote electrical neuromodulation (REN) device for the acute treatment of migraine.BackgroundThere is a significant unmet need for novel effective well-tolerated acute migraine treatments. REN is a novel acute migraine treatment that stimulates upper arm peripheral nerves to induce conditioned pain modulation - an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions. A recent pilot study showed that REN can significantly reduce headache. We have conducted a randomized, double-blind, sham-controlled study to further evaluate the efficacy and safety of REN for the acute treatment of migraine.MethodsThis was a randomized, double-blind, sham-controlled, multicenter study conducted at 7 sites in the United States and 5 sites in Israel. Two hundred and fifty-two adults meeting the International Classification of Headache Disorders criteria for migraine with 2-8 migraine headaches per month were randomized in a 1:1 ratio to active or sham stimulation. A smartphone-controlled wireless device was applied for 30-45 minutes on the upper arm within 1 hour of attack onset; electrical stimulation was at a perceptible but non-painful intensity level. Migraine pain levels were recorded at baseline, 2, and 48 hours post-treatment. Most bothersome symptoms (MBS) were also recorded. The primary efficacy endpoint was the proportion of participants achieving pain relief at 2 hours post-treatment (improvement from severe or moderate pain to mild or none, or from mild pain to none). Relief of MBS and pain-free at 2 hours were key secondary endpoints.ResultsActive stimulation was more effective than sham stimulation in achieving pain relief (66.7% [66/99] vs 38.8% [40/103]; therapeutic gain of 27.9% [CI95% , 15.6-40.2]; P < .0001), pain-free (37.4% vs 18.4%, P = .003), and MBS relief (46.3% vs 22.2%, P = .0008) at 2 hours post-treatment. The pain relief and pain-free superiority of the active treatment was sustained 48 hours post-treatment. The incidence of device-related adverse events was low and similar between treatment groups (4.8% [6/126] vs 2.4% [3/126], P = .499).ConclusionsREN provides superior clinically meaningful relief of migraine pain and MBS compared to placebo, offering a safe and effective non-pharmacological alternative for acute migraine treatment.

Dataset Information

Medical expulsive therapy for ureter stone using naftopidil: A multicenter, randomized, double-blind, and placebo-controlled trial.

Objectives

Materials and methods

Results

Conclusions

Publications

Medical expulsive therapy for ureter stone using naftopidil: A multicenter, randomized, double-blind, and placebo-controlled trial.

Similar Datasets

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