MV140 sublingual vaccine reduces recurrent urinary tract infection in women Results from the first North American clinical experience study.

INTRODUCTION: This is the first North American clinical evidence for MV140, a novel bacterial sublingual vaccine, developed for prevention of recurrent urinary tract infection (UTI) in women. METHODS: Female subjects with ≥3 documented UTIs/year underwent three-month vaccination treatment, nine-month efficacy period, and optional three-month followup (total 15 months). Primary outcome was no clinically diagnosed UTI following vaccination (UTI-free rate). Secondary outcomes included absolute, mean, and median overall reduction in UTI compared to pre-vaccination, quality of life, global response assessment, patient satisfaction, microbiology, and safety. RESULTS: Sixty-seven subjects (mean age 56 years, range 18-80) were enrolled; 64 completed the vaccination period and at least one post-vaccination assessment. Prior to vaccination, subjects reported a mean 6.8 UTIs/year. The UTI-free rate for the nine-month efficacy period was 40.6%. Compared to the infection rate in the year prior to vaccination, the reduction was 75.3% for the nine-month efficacy period post-vaccination. At 12-month followup, 80.3% reported that they were moderately/markedly improved; 58.1% were mostly satisfied, pleased, or delighted, while mean quality of life score improved by 1.5 points. Fourteen of the adverse events in nine subjects were potentially related to the vaccine - all mild and resolved by three months. None of the 13 serious adverse events were related to vaccine. CONCLUSIONS: This first-in-North-America, prospective case series with the sublingual vaccine, MV140, adds further clinical evidence to its safety and effectiveness in reducing recurrent UTIs in women.

An online Sexual Health and Rehabilitation eClinic (TrueNTH SHAReClinic) for prostate cancer patients: a feasibility study.

PURPOSE: The primary objective was to determine the feasibility of implementing the TrueNTH SHAReClinic as a pan-Canadian sexual health and rehabilitation intervention for patients treated for localized prostate cancer. METHODS: The feasibility study was designed to evaluate the accessibility and acceptability of the intervention. Participants from five institutions across Canada were enrolled to attend one pre-treatment and five follow-up online clinic visits over 1 year following their prostate cancer (PC) treatment. RESULTS: Sixty-five patients were enrolled in the intervention. Website analytics revealed that 71% completed the intervention in its entirety, including the educational modules, with an additional 10% completing more than half of the intervention. Five thousand eighty-three views of the educational modules were made along with 654 views of the health library items. Over 1500 messages were exchanged between participants and their sexual health coaches. At 12 months, the intervention received an overall average participant rating of 4.1 out of 5 on a single item satisfaction measure. CONCLUSION: Results support the TrueNTH SHAReClinic as highly acceptable to participants as defined by intervention adherence and engagement. The TrueNTH SHAReClinic demonstrated promise for being a feasible and potentially resource-efficient approach to effectively improving the sexual well-being of patients after PC treatment.

Comparison of < 100 cc prostates and > 100 cc prostates undergoing aquablation for benign prostatic hyperplasia.

INTRODUCTION: Surgical options for benign prostatic hyperplasia (BPH) become limited when treating large prostates due to steep learning curves and less effective treatment. Aquablation (AquaBeam System, PROCEPT BioRobotics, Inc., USA) could remedy this. We compare the effectiveness of Aquablation in large prostates between 80 cc and 100 cc and very large prostates > 100 cc. METHODS: WATER II (NCT03123250) is a prospective, multicenter, international clinical trial of Aquablation for the surgical treatment of LUTS/BPH in men of age 45-80 years with prostates between 80 cc and 150 cc. Aquablation was performed using the AquaBeam System. The reported analysis compares the subgroup of patients with a baseline prostate size of < 100 cc versus those with a prostate size of > 100 cc. Students' t test was used for continuous variables and Fisher's test for ordinal/binary variables. RESULTS: Of 114 screened patients, 101 meeting eligibility criteria were enrolled at 13 US and 3 Canadian sites between September and December 2017. Mean operative time was 31.2 ± 8 min in the < 100 cc subgroup and 41.7 ± 14.9 min in the > 100 cc subgroup. The average length of stay following the procedure for the < 100 cc subgroup was 1.5 ± 0.7 days versus 1.7 ± 1.1 days for the > 100 cc subgroup. Mean changes in International Prostate Symptom Score (IPSS), IPSS quality of life, and IPSS voiding and storage subscores were substantial, occurring soon after treatment and averaging (at 3 months) 16.5, 2.8, 10.6, and 5.8 points, respectively (all p < 0.0001). CONCLUSION: Aquablation clinically normalizes outcomes between patients of the < 100 cc and > 100 cc prostate cohorts. It is safe and effective in patients with large prostate glands (> 100 cc) with a smoother learning curve.

The Prostate Cancer Rehabilitation Clinic: a biopsychosocial clinic for sexual dysfunction after radical prostatectomy.

Purpose: The most prevalent intervention for localized prostate cancer (pca) is radical prostatectomy (rp), which has a 10-year relative survival rate of more than 90%. The improved survival rate has led to a focus on reducing the burden of treatment-related morbidity and improving the patient and partner survivorship experience. Post-rp sexual dysfunction (sdf) has received significant attention, given its substantial effect on patient and partner health-related quality of life. Accordingly, there is a need for sdf treatment to be a fundamental component of pca survivorship programming. Methods: Most research about the treatment of post-rp sdf involves biomedical interventions for erectile dysfunction (ed). Although findings support the effectiveness of pro-erectile agents and devices, most patients discontinue use of such aids within 1 year after their rp. Because side effects of pro-erectile treatment have proved to be inadequate in explaining the gap between efficacy and ongoing use, current research focuses on a biopsychosocial perspective of ed. Unfortunately, there is a dearth of literature describing the components of a biopsychosocial program designed for the post-rp population and their partners. Results: In this paper, we detail the development of the Prostate Cancer Rehabilitation Clinic (pcrc), which emphasizes multidisciplinary intervention teams, active participation by the partner, and a broad-spectrum medical, psychological, and interpersonal approach. Conclusions: The goal of the pcrc is to help patients and their partners achieve optimal sexual health and couple intimacy after rp, and to help design cost-effective and beneficial rehabilitation programs.

Interventions to address sexual problems in people with cancer.

BACKGROUND: Sexual dysfunction in people with cancer is a significant problem. The present clinical practice guideline makes recommendations to improve sexual function in people with cancer. METHODS: This guideline was undertaken by the Interventions to Address Sexual Problems in People with Cancer Expert Panel, a group organized by the Program in Evidence-Based Care (pebc). Consistent with the pebc standardized approach, a systematic search was conducted for existing guidelines, and the literature in medline and embase for the years 2003-2015 was systematically searched for both systematic reviews and primary literature. Evidence found for men and for women was evaluated separately, and no restrictions were placed on cancer type or study design. Content and methodology experts performed an internal review of the resulting draft recommendations, which was followed by an external review by targeted experts and intended users. RESULTS: The search identified 4 existing guidelines, 13 systematic reviews, and 103 studies with relevance to the topic. The present guideline provides one overarching recommendation concerning the discussion of sexual health and dysfunction, which is aimed at all people with cancer. Eleven additional recommendations made separately for men and women deal with issues such as sexual response, body image, intimacy and relationships, overall sexual functioning and satisfaction, and vasomotor and genital symptoms. CONCLUSIONS: To our knowledge this clinical practice guideline is the first to comprehensively evaluate interventions for the improvement of sexual problems in people with cancer. The guideline will be a valuable resource to support practitioners and clinics in addressing sexuality in cancer survivors.

Midurethral sling is the dominant procedure for female stress urinary incontinence: analysis of case logs from certifying American Urologists.

OBJECTIVE: To investigate contemporary trends in the use of midurethral sling procedures for the surgical correction of female stress urinary incontinence over the past decade. METHODS: Annualized case log data for female incontinence surgeries from certifying and recertifying urologists were obtained from the American Board of Urology. Descriptive analysis of the number and type of cases per year was performed. Associations between surgeon characteristics and the use of female incontinence procedures were evaluated. RESULTS: A total of 6355 nonpediatric urologists applied for certification or recertification between 2003 and 2012. Two-thirds (4185) reported performing any procedures for female incontinence. Procedures sharply increased from 4632 in 2003 to 7548 in 2004, then remained relatively stable between 2005 and 2012 (range, 8014-10,238 cases). Traditional procedures decreased from 17% of female incontinence procedures in 2003 to 5% in 2004 to <1% since 2010 (P <.0005). Midurethral sling procedures have risen sharply from 3210 procedures in 2003 to 7200 in 2012 (P <.0005). Endoscopic injection treatments have remained stable. CONCLUSION: Midurethral slings have been widely adopted by urologists over the last decade. Increase in sling usage coincided with a drastic decline in traditional repairs, implying that the newer midurethral slings were replacing these traditional procedures for the treatment of female incontinence. In addition, the fact that the use of periurethral injections did not change significantly during this time period indicates that increased sling usage is responsible for most of the decline in traditional repairs.

High incidence rate and absent family histories in one quarter of patients newly diagnosed with Huntington disease in British Columbia.

The advent of the direct mutation test for Huntington disease (HD) has made it possible to identify a previously unrecognized symptomatic population of HD, including those with an atypical presentation or patients without a family history of HD. The present study investigated the uptake of this test in the province of British Columbia (BC), Canada and assessed the incidence rate and rate of identification of new mutations for HD. All symptomatic individuals residing in BC who were referred for the genetic test for HD between 1993 and 2000 (n=205) were analyzed for CAG expansion, baseline demographics and clinical data, and a family history of HD. A total of 141 (or 68.8%) had a CAG expansion > or =36. Of these, almost one-quarter (24.1%) did not have a family history of HD. An extensive chart review revealed that 11 patients (or 7.8%) had reliable information on both parents (who lived well into old age) and therefore possibly could represent new mutations for HD. This indicates a three to four times higher new mutation rate than previously reported. Our findings also show that the yearly incidence rate for HD was 6.9 per million, which is two times higher than previous incidence studies performed prior to the identification of the HD mutation. We also identified five persons with a clinical presentation of HD but without CAG expansion (genocopies) (2.4%).