Park 2012.
Methods | RCT | |
Participants |
Time of recruitment: post‐operative Population: 121 men who underwent radical prostatectomy (whole population, with or without UI) Included: elderly male patients aged ≥ 65 years, clinically localized prostate cancer (cT1 to T2), Eastern Cooperative Oncology Group performance status of 0 or 1, and written informed consent Excluded: adjuvant or neoadjuvant therapy, severe postoperative complications, a history of intrapelvic surgery, diseases that can affect voiding function, and limitations for exercise intervention, such as patients with serious cardiovascular events or spinal or articular disease Age (mean, SD): A 69.1 (5.7); B 69.4 (7.2) Dropouts: A: 7 (1 orthopaedic surgery for a pre‐existing ankle problem, 1 transurethral surgery for urethral stricture, 4 non‐compliance with follow‐up due to a long distance from the centre to the home or personal affairs, 1 new employment after surgery) B: 8 (1 ophthalmologic surgery for a cataract, 2 adjuvant radiotherapy, 4 non‐compliance with follow‐up due to a long distance from the center to the home or personal affairs, 1 new employment after surgery) Not differential dropout Baseline characteristics: comparable at baseline |
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Interventions |
Time of intervention: post‐operative treatment for all men A (26): patients performed Kegel exercises twice weekly, together with other types of exercises which included resistance training and pelvic flexibility. The intervention started 3 weeks after surgery and lasted 12 weeks B (23): ‘In the control group, only kegel exercises were performed’ Duration of treatment: 15 weeks Follow‐up: 1 week before surgery, 3 weeks and 15 weeks after surgery |
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Outcomes |
Primary outcome (number of men with UI) Cumulative number of incontinent men [defined as > 1 g on 24 hour pad test) 15 weeks: A 7/26; B 13/23 Other outcomes Cumulative number of continent men [defined as < 1 g on 24 hour pad test) 15 weeks: A 19/26; B 10/23, P = 0.035 Urine loss in grams using 24 hour pad test (mean (SD) N) 1 week before surgery: A 0 (NR) 26; B 0 (NR) 23 3 weeks post‐operatively: A 60 (NR) 26; B 83 (NR) 23 15 weeks: A 12 (NR) 26; B 46 (NR) 23 Quality of life ICIQ score (mean (SD) N) 1 week before surgery: A 4 (NR) 26; B 3 (NR) 23 3 weeks post‐operatively: A 10 (NR) 26; B 10 (NR) 23 15 weeks: A 6 (NR) 26; B 10 (NR) 23 SF‐36 physical composite score (mean (SD) N) 1 week before surgery: A 57 (NR) 26; B 54 (NR) 23 3 weeks post‐operatively: A 45 (NR) 26; B 44 (NR) 23 15 weeks: A 57 (NR) 26; B 48 (NR) 23 SF‐36 mental composite score (mean (SD) N) 1 week before surgery: A 45 (NR) 26; B 44.6 (NR) 23 3 weeks post‐operatively: A 44 (NR) 26; B 43 (NR) 23 15 weeks: A 49 (NR) 26; B 46 (NR) 23 Beck Depression Inventory (mean (SD) N) 1 week before surgery: A 9 (NR) 26; B 7.4 (NR) 23 3 weeks post‐operatively: A 8 (NR) 26; B 9 (NR) 23 15 weeks: A 6 (NR) 26; B 9 (NR) 23 NR = Not reported |
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Notes | Details of the combined exercise regime Post‐operative weeks 1 to 4 1) Education about post‐operative symptoms 2) Performing Kegel exercises, recognizing the parapelvic muscles 3) Pelvic floor flexibility fitness: performing pelvic exercises while sitting on a ball Post‐operative weeks 5 to 8 (ball exercises) 1) Performing pelvic exercises while sitting on a ball 2) Performing lower extremity exercises while placing a ball on the wall 3) Lifting a heel on the ball while standing face‐to‐face with the wall 4) Lifting up and down on the ball while spreading and bending legs 5) Performing flank exercises while having a ball in the hand 6) Squeezing the ball with the adductor muscles while lying on a table Post‐operative weeks 9‐12 (elastic band exercises) 1) Lifting the object with an elastic band lateral, anterior, and posterior to the patient’s arms 2) Lifting the legs and then spreading them while attaching an elastic band to the foot Further information provided by author |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “A random number generator was used to determine the randomization allocation in a 1:1 ratio” |
Allocation concealment (selection bias) | Low risk | “Sealed envelope, sequentially numbered, and opened by the trial nurse” |
Blinding of participants (performance bias) | High risk | Blinding of participants was not possible |
Blinding of personnel (performance bias) | High risk | Blinding not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | An independent assessor performed serial measurements |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | A: 7 (1 orthopaedic surgery for a pre‐existing ankle problem, 1 transurethral surgery for urethral stricture, 4 non‐compliance with follow‐up due to a long distance from the centre to the home or personal affairs, 1 new employment after surgery) B: 8 (1 ophthalmologic surgery for a cataract, 2 adjuvant radiotherapy, 4 non‐compliance with follow up due to a long distance from the center to the home or personal affairs, 1 new employment after surgery) No differential dropout |
Selective reporting (reporting bias) | Low risk | Results of outcomes reported |
Financial support | Low risk | Unconditional funding from the “Medical Research Institute, Pusan National University Hospital, Busan, Korea.” |
Approved by medical ethics committee | Low risk | “Our institutional review board approved this prospective, randomized, controlled trial” |
Informed consent | Low risk | Patients signed “written informed consent” |
ITT analysis | High risk | No |