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一项单盲、随机对照试验,旨在评估经皮胫神经刺激(PTNS)治疗有效的女性中,经皮胫神经刺激(TTNS)治疗膀胱过度活动症症状的有效性。

A single-blind, randomized controlled trial to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in Overactive Bladder symptoms in women responders to percutaneous tibial nerve stimulation (PTNS).

机构信息

Physiotherapy Department, Liverpool Women's NHS Trust, Crown Street, Liverpool, L8 7SS, UK.

Department of Health Professions, Manchester Metropolitan University, Brooks Building, 53 Bonsall Street, Manchester, M15 6GX, UK.

出版信息

Physiotherapy. 2019 Dec;105(4):469-475. doi: 10.1016/j.physio.2018.12.002. Epub 2018 Dec 18.

Abstract

OBJECTIVES

To evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared to percutaneous tibial nerve stimulation (PTNS) in sustaining symptom improvement over a 6-month period in women with idiopathic Overactive Bladder (OAB) who had responded to an initial 12-week course of PTNS.

DESIGN

Randomized, active-controlled trial.

PARTICIPANTS

Twenty-four women diagnosed with idiopathic OAB successfully treated with PTNS were included in this study.

INTERVENTIONS

Twelve subjects were allocated to receive monthly sessions of PTNS for six months, and twelve subjects followed a flexible home-based TTNS regime after instruction on the use of a TENS device for the same follow-up time.

OUTCOMES

Participants were assessed at six weeks, three months and six months after completing the initial course of PTNS. Primary outcomes were changes from baseline in urinary frequency, number of episodes of urgency and number of episodes of urge urinary incontinence (UUI). Subjectively reported severity of symptoms and quality of life (QoL) were assessed using the validated OAB questionnaire (OAB-q).

RESULTS

Urinary frequency, episodes of urinary urgency and episodes of UUI did not change significantly between baseline and six months in either group. Similarly, OAB-q scores for severity of symptoms and QoL were maintained within both arms for the duration of the study. There were no statistically significant differences between the groups in any of the outcome measures at any of the study points.

CONCLUSION

TTNS is effective in the maintenance of symptom improvement in women with OAB who had positively responded to a course of 12 weekly PTNS sessions. The trial was registered in the Clinicaltrials.gov PRS database (Identifier: NCT02377765).

摘要

目的

评估经皮胫神经刺激(PTNS)与经皮胫神经刺激(TTNS)相比,在对初始 12 周 PTNS 治疗有反应的特发性膀胱过度活动症(OAB)女性中,在 6 个月期间维持症状改善的有效性。

设计

随机、活性对照试验。

参与者

24 名被诊断为特发性 OAB 的女性成功接受了 PTNS 治疗,被纳入本研究。

干预措施

12 名受试者被分配接受每月一次的 PTNS 治疗,共 6 个月,12 名受试者在接受 TENS 设备使用指导后,遵循灵活的家庭 TTNS 方案,进行相同的随访时间。

结果

在完成初始 PTNS 疗程后 6 周、3 个月和 6 个月对参与者进行评估。主要结果是从基线开始,尿频率、尿急发作次数和急迫性尿失禁发作次数的变化。使用经过验证的 OAB 问卷(OAB-q)评估主观报告的症状严重程度和生活质量(QoL)。

结果

两组基线至 6 个月时,尿频率、尿急发作次数和急迫性尿失禁发作次数均无显著变化。同样,在研究期间,两组的 OAB-q 评分在症状严重程度和 QoL 方面均保持不变。在任何研究点,两组在任何结果测量指标上均无统计学差异。

结论

TTNS 可有效维持对 12 周 PTNS 疗程有积极反应的 OAB 女性的症状改善。该试验在 Clinicaltrials.gov PRS 数据库中注册(标识符:NCT02377765)。

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