Fode Mikkel, Sønksen Jens
Department of Urology, Herlev University Hospital, Herlev, Denmark.
Neurourol Urodyn. 2015 Feb;34(2):117-22. doi: 10.1002/nau.22536. Epub 2013 Nov 27.
To examine penile vibratory stimulation (PVS) in the treatment of post-prostatectomy urinary incontinence (UI).
Patients with post-prostatectomy UI were included in a 12-week trial. A 24-hr pad test and a 72-hr voiding diary were collected at baseline. Participants were randomized to receive PVS for the first 6 weeks (group 1) or for the final 6 weeks (group 2) of the study. The primary outcome was the difference in leakage between groups 1 and 2 at 6 weeks as measured by changes in the pad test. The trial was registered at www.clinicaltrials.org (NCT01540656).
Data from 31 men were available for analyses. The difference in the change on the pad test between the groups did not reach statistical significance at 6 weeks (P = 0.13) while the change in incontinence episodes between groups approached statistical significance (P = 0.052). However, there was a median reduction of -33 g (P = 0.021) on the pad test and a median reduction in daily incontinence episodes of -1 (P = 0.023) in group 1 at 6 weeks. At 12 weeks, group 2 had a median decrease on the pad test of -8 g (P = 0.10) and no change in incontinence episodes. A pooled analysis showed a decline on the pad test of -13.5 g (P = 0.004) after PVS. Small improvements were seen in subjective symptom scores and 58% stated to be satisfied with PVS. Self-limiting side effects were experienced by 15% of patients.
PVS is feasible in the treatment of post-prostatectomy UI. Larger trials are needed to document the clinical efficacy.
探讨阴茎振动刺激(PVS)治疗前列腺切除术后尿失禁(UI)的效果。
前列腺切除术后尿失禁患者纳入一项为期12周的试验。在基线时收集24小时尿垫试验和72小时排尿日记。参与者被随机分为在研究的前6周接受PVS(第1组)或最后6周接受PVS(第2组)。主要结局是通过尿垫试验变化测量的第1组和第2组在6周时渗漏的差异。该试验已在www.clinicaltrials.org注册(NCT01540656)。
31名男性的数据可用于分析。两组在6周时尿垫试验变化的差异未达到统计学意义(P = 0.13),而两组间尿失禁发作次数的变化接近统计学意义(P = 0.052)。然而,第1组在6周时尿垫试验中位数减少-33 g(P = 0.021),每日尿失禁发作次数中位数减少-1(P = 0.023)。在12周时,第2组尿垫试验中位数减少-8 g(P = 0.10),尿失禁发作次数无变化。汇总分析显示PVS后尿垫试验减少-13.5 g(P = 0.004)。主观症状评分有小幅改善,58%的患者表示对PVS满意。15%的患者出现自限性副作用。
PVS治疗前列腺切除术后尿失禁是可行的。需要更大规模的试验来证明其临床疗效。