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Perioperative mobile telehealth program for post-prostatectomy incontinence: a randomized clinical trial [with consumer summary]
Goode PS, Johnson 2nd TM, Newman DK, Vaughan CP, Echt KV, Markland AD, Kennedy R, Van Arsdalen KN, Rais-Bahrami S, Issa MM, Barnacastle S, Wright KC, McCabe P, Malone MP, Redden DT, Burgio KL
The Journal of Urology 2022 Aug;208(2):379-387
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

PURPOSE: Perioperative pelvic floor muscle training can hasten recovery of bladder control and reduce severity of urinary incontinence following radical prostatectomy. Nevertheless, most men undergoing prostatectomy do not receive this training. The purpose of this trial was to test the effectiveness of interactive mobile telehealth (mHealth) to deliver an evidence-based perioperative behavioral training program for post-prostatectomy incontinence. MATERIALS AND METHODS: This was a three-site, 2-arm, randomized trial (2014 to 2019). Men with prostate cancer scheduled to undergo radical prostatectomy were randomized to a perioperative behavioral program (education, pelvic floor muscle training, progressive exercises, bladder control techniques) or a general prostate cancer education control condition, both delivered by mHealth for 1 to 4 weeks preoperatively and 8 weeks postoperatively. The primary outcome was time to continence following surgery measured by the International Consultation on Incontinence Questionnaire Short-Form. Secondary outcomes measured at 6, 9 and 12 months included Urinary Incontinence Subscale of Expanded Prostate Cancer Index Composite; pad use; International Prostate Symptom Score QoL Question; and Global Perception of Improvement. RESULTS: 245 men (ages 42 to 78 years; mean 61.7) were randomized. Survival analysis using the Kaplan-Meier estimate showed no statistically significant between-group differences in time to continence. Analyses at 6 months indicated no statistically significant between-group differences in ICIQ scores (mean 7.1 versus 7.0, p = 0.7) or other secondary outcomes. CONCLUSIONS: mHealth delivery of a perioperative program to reduce post-prostatectomy incontinence was not more effective than an mHealth education program. More research is needed to assess whether perioperative mHealth programs can be a helpful addition to standard prostate cancer care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01960998.

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