作者
Eugenie Johnson,Charalampos Mamoulakis,Akvile Stoniute,Muhammad Imran Omar,Sanjay Sinha
摘要
Background 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. Objectives To assess the effects of conservative interventions for managing urinary incontinence after prostate surgery. Search methods 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. Selection criteria 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. Data collection and analysis 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. Main results 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.