Pfilates and Hypopressives for the Treatment of Urinary Incontinence After Radical Prostatectomy: Results of a Feasibility Randomized Controlled Trial.

BACKGROUND: Urinary incontinence (UI) is an important side effect of radical prostatectomy (RP). Coactivation of surrounding muscles via novel techniques for pelvic floor rehabilitation known as Pfilates and Hypopressives has not been compared to pelvic floor muscle exercises (PFMXs) for UI. OBJECTIVE: To assess the feasibility and efficacy of isolated PFMXs with and without the addition of Pfilates and Hypopressives on UI recovery following RP. DESIGN: Randomized controlled trial. SETTING: Participants were recruited from a community and tertiary cancer center in Toronto, Canada. PARTICIPANTS: A total of 226 patients undergoing RP were assessed for eligibility. One hundred twenty-two patients were eligible and 50 consented to participate; 37 participants completed the trial. METHODS: Participants were randomized to either isolated PFMX (control) or PFMX plus Pfilates and Hypopressives (advanced pelvic floor exercises; APFX) groups. PFMX participants (n = 25) received instructions for isolated pelvic floor contractions starting with 30 contractions per day during weeks 1 to 2 up to 180 per day for weeks 7 to 26. The APFX group (n = 25) received a comparable volume of exercises. MAIN OUTCOME MEASUREMENTS: Feasibility was assessed by rates of recruitment, adverse events, and study-arm compliance. Information about UI and quality of life was collected 1 week before surgery and at 2, 6, 12, and 26 weeks after surgery. RESULTS: The recruitment rate was 41%, adherence to the PFMXs and APFXs was >70%, and there were no reported adverse events. Between-group differences were observed in the frequency of self-reported 24-hour urinary leakage (rate ratio 0.45, 95% confidence interval [CI] 0.2-0.98) and during waking hours (rate ratio 0.43, 95% CI 0.20-0.91) at 26 weeks after surgery favoring APFX. CONCLUSIONS: Pfilates and Hypopressives are feasible in men undergoing RP, and preliminary data suggest a potential benefit in aiding recovery of urinary control. Larger studies with longer follow-up are warranted. LEVEL OF EVIDENCE: II.

Prehabilitation and acute postoperative physical activity in patients undergoing radical prostatectomy: a secondary analysis from an RCT.

BACKGROUND: Physical activity via early mobilization after surgery is recommended to help reduce the risk of postoperative adverse effects and to improve recovery. We explored whether prehabilitation is associated with differences in physical activity during the postoperative inpatient stay and the week after discharge in men undergoing abdominal surgery. METHODS: This study was a pre-planned secondary analysis of a larger randomized controlled trial of home-based exercise prehabilitation versus control for men undergoing radical prostatectomy. Twenty-one participants in both the prehabilitation and control groups wore accelerometers from postoperative day 1 until 7 days after discharge. Mean physical activity (minutes) during postoperative day 1 (inpatient) and 1 week following hospital discharge (outpatient) were estimated using ANCOVA. Pearson's correlation coefficients were conducted for mean in- an outpatient physical activity with length of stay and changes in 6-min walk test (6MWT) over the course of the prehabilitation period. RESULTS: Nineteen participants in each group provided usable accelerometry data for analysis. Inpatient physical activity of light or greater activity during postoperative day 1 for prehabilitation and control groups were 442.5 ± 40.2 and 324.0 ± 40.2 min, respectively (∆ = 117.5 ± 57.8 min, 95%CI [0.04, 235.0]). During the outpatient period, mean daily physical activity was 448.4 ± 31.2 and 491.42 ± 31.2 min for prehabilitation and control participants, respectively (∆ = 42.6 ± 44.9 min; 95% CI [- 134.0, 48.7]). There were no correlations between in- or outpatient physical activity and preoperative changes in 6MWT or length of stay. CONCLUSIONS: Accelerometry-based measurement of physical activity in the acute postoperative period is feasible in older men undergoing abdominal surgery. Prehabilitation may be associated with increased inpatient physical activity; however, larger and longer studies are needed to elucidate any associated effects on clinical and patient outcomes. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02036684 registered January 15, 2014.

Prehabilitation for radical prostatectomy: A multicentre randomized controlled trial.

INTRODUCTION: Preoperative exercise and fitness are predictors of surgical recovery; however, little is known of the effect of preoperative exercise-based conditioning, known as prehabilitation, in this for men undergoing radical prostatectomy. Our study examined the feasibility and effects of prehabilitation on perioperative and postoperative outcomes in men undergoing radical prostatectomy. METHODS: This feasibility RCT compared prehabilitation (PREHAB) versus a control condition (CON) in 86 men undergoing radical prostatectomy. PREHAB consisted of home-based, moderate-intensity exercise prior to surgery. Both groups received a preoperative pelvic floor training regimen. Feasibility was assessed via rates of recruitment, attrition, intervention duration and adherence, and adverse events. Clinical outcomes included surgical complications, and length of stay. The following outcomes were assessed at baseline, prior to surgery, and 4, 12, and 26-weeks postoperatively: 6-min walk test (6MWT), upper-extremity strength, quality of life, psychosocial wellbeing, urologic symptoms, and physical activity volume. RESULTS: The recruitment rate was 47% and attrition rates were 25% and 33% for PREHAB and CON, respectively. Adherence to PREHAB was 69% with no serious intervention-related adverse events. After the intervention and prior to surgery, PREHAB participants demonstrated less anxiety (P = 0.035) and decreased body fat percentage (P = 0.001) compared to CON. Four-weeks postoperatively, PREHAB participants had greater 6MWT scores of clinical significance compared to CON (P = 0.006). Finally, compared to CON, grip strength and anxiety were also greater in the PREHAB at 26-weeks (P = 0.022) and (P = 0.025), respectively. CONCLUSION: While feasible and safe, prehabilitation has promising benefits to physical and psychological wellbeing at salient timepoints relative to radical prostatectomy.

A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol.

BACKGROUND: Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with urinary incontinence and has a significant negative impact on quality of life. Pelvic floor exercises are the most common non-invasive management strategy for urinary incontinence following radical prostatectomy; however, studies provide inconsistent findings regarding their efficacy. One potential reason for sub-optimal efficacy of these interventions is the under-utilization of regional muscles that normally co-activate with the pelvic floor, such as the transverse abdominis, rectus abdominis, and the diaphragm. Two novel approaches to improve urinary continence recovery are 'Pfilates' and 'Hypopressives' that combine traditional pelvic floor exercises with the activation of additional supportive muscles. Our study will compare an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives, to a conventional pelvic floor exercises regimen for the treatment of post-radical prostatectomy urinary incontinence. METHODS/DESIGN: This is a pilot, randomized controlled trial of advanced pelvic floor muscle training versus conventional pelvic floor exercises for men with localized prostate cancer undergoing radical prostatectomy. Eighty-eight men who will be undergoing radical prostatectomy at hospitals in Toronto, Canada will be recruited. Eligible participants must not have undergone androgen deprivation therapy and/or radiation therapy. Participants will be randomized 1:1 to receive 26 weeks of the advanced or conventional pelvic floor exercise programs. Each program will be progressive and have comparable exercise volume. The primary outcomes are related to feasibility for a large, adequately powered randomized controlled trial to determine efficacy for the treatment of urinary incontinence. Feasibility will be assessed via recruitment success, participant retention, outcome capture, intervention adherence, and prevalence of adverse events. Secondary outcomes of intervention efficacy include measures of pelvic floor strength, urinary incontinence, erectile function, and quality of life. Secondary outcome measures will be collected prior to surgery (baseline), and at 2, 6, 12, 26-weeks post-operatively. DISCUSSION: Pfilates and Hypopressives are novel approaches to optimizing urinary function after radical prostatectomy. This trial will provide the foundation of data for future, large-scale trials to definitively describe the effect of these advanced pelvic floor exercise modalities compared to conventional pelvic floor exercise regimes for men with prostate cancer undergoing radical prostatectomy TRIAL REGISTRATION: Clinicalstrials.gov Identifier: NCT02233608.

Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial.

BACKGROUND: An emerging field of research describes the role of preoperative health behaviours, known as prehabilitation. The preoperative period may be a more physically and emotionally salient time to introduce and foster chronic adherence to health behaviours, such as exercise, in patients compared to post-treatment during recovery. Moreover, physical and psychosocial improvements during the preoperative period may translate into an enhanced recovery trajectory with reduced operative complications and postoperative adverse effects. No studies have assessed prehabilitation for men with prostate cancer undergoing radical prostatectomy. METHODS/DESIGN: This is a multi-centre, pilot randomized control trial conducted at two Canadian urban teaching hospitals. 100 men undergoing radical prostatectomy for prostate cancer with no contraindications to exercise will be recruited and randomized to the prehabiliation program or usual care. Prehabilitation participants will engage in a preoperative, individualized exercise program including pelvic floor muscle strengthening instructions and a healthy lifestyle guide for men with prostate cancer. These participants will be asked to engage in 60 minutes of home-based, unsupervised, moderate-intensity exercise on 3-4 days per week. Usual care participants will receive the same pelvic floor muscle strengthening instructions and healthy lifestyle guide only. We will assess the feasibility of conducting an adequately powered trial of the same design via recruitment rate, programmatic adherence/contamination, attrition, and safety. Estimates of intervention efficacy will be captured through measurements at baseline (4-8 weeks preoperatively), within 1 week prior to surgery, and postoperatively at 4, 12, and 26 weeks. Efficacy outcomes include: fatigue, quality of life, urinary incontinence, physical fitness, body composition, aerobic fitness, pain, and physical activity volume. DISCUSSION: The primary outcome of this study is to determine the feasibility of conducting a full-scale, randomized controlled trial of prehabilitation versus usual care and to estimate effect sizes that will inform sample size determinations for subsequent trials in this field. To our knowledge, this is the first study to examine a structured presurgical exercise program for men undergoing radical prostatectomy for prostate cancer. This trial will advance our understanding of strategies to efficiently and effectively use the preoperative period to optimize postoperative recovery. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02036684.