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.

Exploring gay couples' experience with sexual dysfunction after radical prostatectomy: a qualitative study.

This exploratory study examines the experience of three gay couples managing sexual dysfunction as a result of undergoing a radical prostatectomy. Semi-structured interviews were conducted as part of a larger study at an urban hospital in Toronto, Ontario, Canada. Interview transcripts were transcribed verbatim, and analyzed using interpretative phenomenological analysis. The authors clustered 18 subordinate themes under 3 superordinate themes: (a) acknowledging change in sexual experience (libido, erectile function, sexual activity, orgasmic function); (b) accommodating change in sexual experience (strategies: emphasizing intimacy, embracing plan B, focus on the other; barriers: side-effect concerns, loss of naturalness, communication breakdown, failure to initiate, trial and failure, partner confounds); and (c) accepting change in sexual experience (indicators: emphasizing health, age attributions, finding a new normal; barriers: uncertain outcomes, treatment regrets). Although gay couples and heterosexual couples share many similar challenges, we discovered that gay men have particular sexual roles and can engage in novel accommodation practices, such as open relationships, that have not been noted in heterosexual couples. All couples, regardless of their level of sexual functioning, highlighted the need for more extensive programming related to sexual rehabilitation. Equitable rehabilitative support is critical to assist homosexual couples manage distress associated with prostatectomy-related sexual dysfunction.

The Anatomy of a Hybrid In-Person and Virtual Sexual Health Clinic in Oncology.

Sexual health is compromised by the diagnosis and treatment of virtually all cancer types. Despite the prevalence and negative impact of sexual dysfunction, sexual health clinics are the exception in cancer centers. Consequently, there is a need for effective, efficient, and inclusive sexual health programming in oncology. This paper describes the development of the innovative Sexual Health Clinic (SHC) utilizing a hybrid model of integrated in-person and virtual care. The SHC evolved from a fusion of the in-person and virtual prostate cancer clinics at Princess Margaret. This hybrid care model was adapted to include six additional cancer sites (cervical, ovarian, testicular, bladder, kidney, and head and neck). The SHC is theoretically founded in a biopsychosocial framework and emphasizes interdisciplinary intervention teams, participation by the partner, and a medical, psychological, and interpersonal approach. Virtual visits are tailored to patients based on biological sex, cancer type, and treatment type. Highly trained sexual health counselors facilitate the virtual clinic and provide an additional layer of personalization and a "human touch". The in-person visits complement virtual care by providing comprehensive sexual health assessment and sexual medicine prescription. The SHC is an innovative care model which has the potential to close the gap in sexual healthcare. The SHC is designed as a transferable, stand-alone clinic which can be shared with cancer centers.

Web-Based Peer Navigation for Men with Prostate Cancer and Their Family Caregivers: A Pilot Feasibility Study.

This study assessed the feasibility, acceptability and potential effects of True North Peer Navigation (PN)­a web-based peer navigation program for men with prostate cancer (PC) and their family caregivers. A one-arm, pre-post pilot feasibility study was conducted at two cancer centres in Canada. Participants were matched through a web-app with a specially trained peer navigator who assessed needs and barriers to care, provided support and encouraged a proactive approach to health for 3 months. Descriptive statistics were calculated, along with paired t-tests. True North PN was feasible, with 57.9% (84/145) recruitment, 84.5% (71/84) pre-questionnaire, 77.5% (55/71) app registration, 92.7% (51/55) match and 66.7% (34/51) post-questionnaire completion rates. Mean satisfaction with Peer Navigators was 8.4/10 (SD 2.15), mean program satisfaction was 6.8/10 (SD 2.9) and mean app usability was 60/100 (SD 14.8). At 3 months, mean ± SE patient/caregiver activation had improved by 11.5 ± 3.4 points (p = 0.002), patient quality of life by 1.1 ± 0.2 points (p < 0.0001), informational support by 0.4 ± 0.17 points (p = 0.03), practical support by 0.5 ± 0.25 points (p = 0.04) and less need for support related to fear of recurrence among patients by 0.4 ± 19 points (p = 0.03). The True North web-based peer navigation program is highly feasible and acceptable among PC patients and caregivers, and the associated improvements in patient and caregiver activation are promising. A randomized controlled trial is warranted to determine effectiveness.

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.

Canadian consensus algorithm for erectile rehabilitation following prostate cancer treatment.

INTRODUCTION: The present descriptive analysis carried out by a pan-Canadian panel of expert healthcare practitioners (HCPs) summarizes best practices for erectile rehabilitation following prostate cancer (PCa) treatment. This algorithm was designed to support an online sexual health and rehabilitation e-clinic (SHARe-Clinic), which provides biomedical guidance and supportive care to Canadian men recovering from PCa treatment. The implications of the algorithm may be used inform clinical practice in community settings. METHODS: Men's sexual health experts convened for the TrueNTH Sexual Health and Rehabilitation Initiative Consensus Meeting to address concerns regarding erectile dysfunction (ED) therapy and management following treatment for PCa. The meeting brought together experts from across Canada for a discussion of current practices, latest evidence-based literature review, and patient interviews. RESULTS: An algorithm for ED treatment following PCa treatment is presented that accounts for treatment received (surgery or radiation), degree of nerve-sparing, and level of pro-erectile treatment invasiveness based on patient and partner values. This algorithm provides an approach from both a biomedical and psychosocial focus that is tailored to the patient/partner presentation. Regular sexual activity is recommended, and the importance of partner involvement in the treatment decision-making process is highlighted, including the management of partner sexual concerns. CONCLUSIONS: The algorithm proposed by expert consensus considers important factors like the type of PCa treatment, the timeline of erectile recovery, and patient values, with the goal of becoming a nationwide standard for erectile rehabilitation following PCa treatment.

Serial personal digital assistant data capture of health-related quality of life: a randomized controlled trial in a prostate cancer clinic.

BACKGROUND: In clinical and research practice linked to prostate cancer treatment, frequent monitoring of patient health-related quality of life (HRQOL) is essential. Practical and analytic limitations of paper questionnaire data capture may be overcome with the use of self-administered personal digital assistant (PDA) data collection. The objective of this study was to assess the reliability, validity, and feasibility of using PDA in place of paper versions of the International Prostate Symptom Score (IPSS), the Patient Oriented Prostate Cancer Utility Survey (PORPUS), and the International Index of Erectile Function-5 (IIEF-5) in a prostate cancer clinic setting. METHODS: 152 participants were randomly assigned to one of three conditions: 1) paper followed by PDA survey; 2) PDA followed by paper survey; or 3) PDA followed by PDA survey. Evaluation included an assessment of data quality (internal consistency, test-retest reliability, response correlation, completeness of data), and feasibility (participation rates, time to completion, preference and difficulty/ease of using PDA). RESULTS: Internal consistency was similar for both PDA and paper applications. Test-retest reliability was confirmed for PDA repeated administration. Data from paper and PDA questionnaires were strongly correlated. Lower missed item rates were found in PDA administration. 82.8% of participants preferred using the PDA or had no preference. Mean difficulty/ease ratings indicated that participants found the PDA easy to use. Age did not significantly correlate with preference or difficulty. CONCLUSION: The results confirm the adaptability of the IPSS, IIEF-5, and the PORPUS to PDA administration. Similarly, the findings of this study support the feasibility of using PDA technology for HRQOL serial data capture in the prostate cancer patient population.