Dataset Information

TAS-303 effects on urethral sphincter function in women with stress urinary incontinence: phase I study.

ABSTRACT:

Introduction and hypothesis

TAS-303, which selectively inhibits noradrenaline reuptake, was developed for treating stress urinary incontinence (SUI). The proximal urethra mainly comprises smooth muscle fibers in which ?1 adrenergic receptors are abundant. This study was conducted to evaluate the effect of TAS-303 on urethral function and its safety profile in female patients with SUI.

Methods

In total, 16 women (age, 20-64 years) with SUI and?>?5.0 g of leakage in the 1-h pad test at screening were randomized and administered the assigned treatment in a double-blind manner. The primary end point was change in the maximal urethral closure pressure (MUCP) at 6 h post-dose. The secondary end point was change in the urethral closure pressure of the entire urethra and each urethral region (proximal, middle, and distal) at 6 h post-dose. The results were analyzed using a t-test.

Results

The mean change ± standard deviation in MUCP at 6 h post-dose was 3.473?±?12.154 cmH₂O for TAS-303 and 2.615?±?9.794 cmH₂O for placebo (between-group difference: 0.858 cmH₂O, P?=?0.8047). The mean changes ± standard deviation in urethral closure pressure of the proximal urethra at 6 h after the administration of TAS-303 18 mg and placebo were 3.863?±?10.941 and 1.634?±?12.093, respectively (between-group difference: 2.229 cmH₂O, P?=?0.5976).

Conclusions

No significant difference in MUCP and urethral closure pressure was found between TAS-303 and placebo. However, the change in the proximal urethral closure pressure with TAS-303 was larger than that with placebo. This suggests that TAS-303 has pharmacological effects on urethral sphincteric function.

SUBMITTER: Yono M

PROVIDER: S-EPMC7902327 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

TAS-303 effects on urethral sphincter function in women with stress urinary incontinence: phase I study.

Yono Makoto M Irie Shin S Gotoh Momokazu M

International urogynecology journal 20201010 3

<h4>Introduction and hypothesis</h4>TAS-303, which selectively inhibits noradrenaline reuptake, was developed for treating stress urinary incontinence (SUI). The proximal urethra mainly comprises smooth muscle fibers in which α1 adrenergic receptors are abundant. This study was conducted to evaluate the effect of TAS-303 on urethral function and its safety profile in female patients with SUI.<h4>Methods</h4>In total, 16 women (age, 20-64 years) with SUI and > 5.0 g of leakage in the 1-h pad test ...[more]

PMID: 32747975

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Project description:ImportanceElectroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited.ObjectiveTo assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI.Design, setting, and participantsMulticenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015.InterventionsParticipants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints.Main outcomes and measuresThe primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes).ResultsAmong the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild.Conclusions and relevanceAmong women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention.Trial registrationclinicaltrials.gov Identifier: NCT01784172.

Dataset Information

TAS-303 effects on urethral sphincter function in women with stress urinary incontinence: phase I study.

Introduction and hypothesis

Methods

Results

Conclusions

Publications

TAS-303 effects on urethral sphincter function in women with stress urinary incontinence: phase I study.

Similar Datasets

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