Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
NIHR Innovation Observatory, Newcastle University, Newcastle upon Tyne, UK.
Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.
Men may need to undergo prostate surgery to treat prostate cancer or benign prostatic hyperplasia. After these surgeries, men may experience urinary incontinence (UI). Conservative treatments such as pelvic floor muscle training (PFMT), electrical stimulation and lifestyle changes can be undertaken to help manage the symptoms of UI.
To assess the effects of conservative interventions for managing urinary incontinence after prostate surgery.
We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearched journals and conference proceedings (searched 22 April 2022). We also searched the reference lists of relevant articles.
We included randomised controlled trials (RCTs) and quasi-RCTs of adult men (aged 18 or over) with UI following prostate surgery for treating prostate cancer or LUTS/BPO. We excluded cross-over and cluster-RCTs. We investigated the following key comparisons: PFMT plus biofeedback versus no treatment; sham treatment or verbal/written instructions; combinations of conservative treatments versus no treatment, sham treatment or verbal/written instructions; and electrical or magnetic stimulation versus no treatment, sham treatment or verbal/written instructions.
We extracted data using a pre-piloted form and assessed risk of bias using the Cochrane risk of bias tool. We used the GRADE approach to assess the certainty of outcomes and comparisons included in the summary of findings tables. We used an adapted version of GRADE to assess certainty in results where there was no single effect measurement available.
We identified 25 studies including a total of 3079 participants. Twenty-three studies assessed men who had previously undergone radical prostatectomy or radical retropubic prostatectomy, while only one study assessed men who had undergone transurethral resection of the prostate. One study did not report on previous surgery. Most studies were at high risk of bias for at least one domain. The certainty of evidence assessed using GRADE was mixed. PFMT plus biofeedback versus no treatment, sham treatment or verbal/written instructions Four studies reported on this comparison. PFMT plus biofeedback may result in greater subjective cure of incontinence from 6 to 12 months (1 study; n = 102; low-certainty evidence). However, men undertaking PFMT and biofeedback may be less likely to be objectively cured at from 6 to 12 months (2 studies; n = 269; low-certainty evidence). It is uncertain whether undertaking PFMT and biofeedback has an effect on surface or skin-related adverse events (1 study; n = 205; very low-certainty evidence) or muscle-related adverse events (1 study; n = 205; very low-certainty evidence). Condition-specific quality of life, participant adherence to the intervention and general quality of life were not reported by any study for this comparison. Combinations of conservative treatments versus no treatment, sham treatment or verbal/written instructions Eleven studies assessed this comparison. Combinations of conservative treatments may lead to little difference in the number of men being subjectively cured or improved of incontinence between 6 and 12 months (RR 0.97, 95% CI 0.79 to 1.19; 2 studies; n = 788; low-certainty evidence; in absolute terms: no treatment or sham arm: 307 per 1000 and intervention arm: 297 per 1000). Combinations of conservative treatments probably lead to little difference in condition-specific quality of life (MD -0.28, 95% CI -0.86 to 0.29; 2 studies; n = 788; moderate-certainty evidence) and probably little difference in general quality of life between 6 and 12 months (MD -0.01, 95% CI -0.04 to 0.02; 2 studies; n = 742; moderate-certainty evidence). There is little difference between combinations of conservative treatments and control in terms of objective cure or improvement of incontinence between 6 and 12 months (MD 0.18, 95% CI -0.24 to 0.60; 2 studies; n = 565; high-certainty evidence). However, it is uncertain whether participant adherence to the intervention between 6 and 12 months is increased for those undertaking combinations of conservative treatments (RR 2.08, 95% CI 0.78 to 5.56; 2 studies; n = 763; very low-certainty evidence; in absolute terms: no intervention or sham arm: 172 per 1000 and intervention arm: 358 per 1000). There is probably no difference between combinations and control in terms of the number of men experiencing surface or skin-related adverse events (2 studies; n = 853; moderate-certainty evidence), but it is uncertain whether combinations of treatments lead to more men experiencing muscle-related adverse events (RR 2.92, 95% CI 0.31 to 27.41; 2 studies; n = 136; very low-certainty evidence; in absolute terms: 0 per 1000 for both arms). Electrical or magnetic stimulation versus no treatment, sham treatment or verbal/written instructions We did not identify any studies for this comparison that reported on our key outcomes of interest.
AUTHORS' CONCLUSIONS: Despite a total of 25 trials, the value of conservative interventions for urinary incontinence following prostate surgery alone, or in combination, remains uncertain. Existing trials are typically small with methodological flaws. These issues are compounded by a lack of standardisation of the PFMT technique and marked variations in protocol concerning combinations of conservative treatments. Adverse events following conservative treatment are often poorly documented and incompletely described. Hence, there is a need for large, high-quality, adequately powered, randomised control trials with robust methodology to address this subject.
男性可能需要接受前列腺手术来治疗前列腺癌或良性前列腺增生。这些手术后,男性可能会出现尿失禁(UI)。保守治疗,如盆底肌训练(PFMT)、电刺激和生活方式改变,可以帮助管理 UI 的症状。
评估保守干预措施在治疗前列腺手术后尿失禁中的效果。
我们检索了 Cochrane 尿控专题登记册,其中包含从 Cochrane 中央对照试验注册库(CENTRAL)、MEDLINE、MEDLINE 正在处理、MEDLINE 预印本、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台(WHO ICTRP)和手工检索的期刊和会议论文集(2022 年 4 月 22 日检索)中确定的试验。我们还检索了相关文章的参考文献列表。
我们纳入了成年男性(18 岁及以上)在接受前列腺癌或 LUTS/BPO 治疗的前列腺手术后出现 UI 的随机对照试验(RCT)和准随机对照试验。我们排除了交叉和群组 RCT。我们调查了以下关键比较:PFMT 加生物反馈与无治疗;假治疗或口头/书面指令;保守治疗联合与无治疗、假治疗或口头/书面指令;以及电或磁刺激与无治疗、假治疗或口头/书面指令。
我们使用预编程表格提取数据,并使用 Cochrane 偏倚风险工具评估风险。我们使用 GRADE 方法评估结局和纳入汇总结局表的比较的确定性。我们使用 GRADE 的改编版本来评估在没有单一效果测量值可用的情况下结果的确定性。
我们确定了 25 项研究,共纳入 3079 名参与者。23 项研究评估了先前接受过根治性前列腺切除术或根治性经直肠前列腺切除术的男性,而只有 1 项研究评估了接受经尿道前列腺切除术的男性。一项研究没有报告先前的手术。大多数研究在至少一个领域存在高偏倚风险。使用 GRADE 评估的证据确定性是混合的。PFMT 加生物反馈与无治疗、假治疗或口头/书面指令 四项研究报告了这一比较。PFMT 加生物反馈可能会导致在 6 至 12 个月时主观上治愈尿失禁的比例更高(1 项研究;n = 102;低确定性证据)。然而,接受 PFMT 和生物反馈的男性在 6 至 12 个月时更不可能客观治愈(2 项研究;n = 269;低确定性证据)。目前还不确定接受 PFMT 和生物反馈是否会对皮肤相关不良事件(1 项研究;n = 205;非常低确定性证据)或肌肉相关不良事件(1 项研究;n = 205;非常低确定性证据)产生影响。条件特异性生活质量、参与者对干预的依从性和一般生活质量在这一比较中没有被任何研究报告。保守治疗联合与无治疗、假治疗或口头/书面指令 11 项研究评估了这一比较。保守治疗联合可能导致在 6 至 12 个月时,主观上治愈或改善尿失禁的男性数量差异较小(RR 0.97,95% CI 0.79 至 1.19;2 项研究;n = 788;低确定性证据;绝对值:无治疗或假治疗组:307 人/每 1000 人,干预组:297 人/每 1000 人)。保守治疗联合可能对 6 至 12 个月时的条件特异性生活质量(MD -0.28,95% CI -0.86 至 0.29;2 项研究;n = 788;中等确定性证据)和一般生活质量(MD -0.01,95% CI -0.04 至 0.02;2 项研究;n = 742;中等确定性证据)差异较小。在 6 至 12 个月时,保守治疗联合与对照组在客观上治愈或改善尿失禁方面差异较小(MD 0.18,95% CI -0.24 至 0.60;2 项研究;n = 565;高确定性证据)。然而,目前还不确定在 6 至 12 个月期间,接受保守治疗联合的参与者的干预依从性是否会增加(RR 2.08,95% CI 0.78 至 5.56;2 项研究;n = 763;非常低确定性证据;绝对值:无干预或假治疗组:172 人/每 1000 人,干预组:358 人/每 1000 人)。在皮肤相关不良事件方面,保守治疗联合与对照组之间可能没有差异(2 项研究;n = 853;中等确定性证据),但目前还不确定治疗联合是否会导致更多的男性出现肌肉相关不良事件(RR 2.92,95% CI 0.31 至 27.41;2 项研究;n = 136;非常低确定性证据;绝对值:两组均为 0 人/每 1000 人)。电或磁刺激与无治疗、假治疗或口头/书面指令 我们没有发现任何报告我们感兴趣的关键结果的研究。
尽管有 25 项试验,但前列腺手术后单独或联合使用保守治疗的价值仍不确定。现有试验通常规模较小,存在方法学缺陷。这些问题因 PFMT 技术缺乏标准化以及保守治疗联合方案中存在明显的变化而进一步加剧。保守治疗后的不良事件往往记录不完整,描述不完整。因此,需要进行大型、高质量、充分有力、随机对照试验,并采用稳健的方法来解决这一问题。