Ogden, Utah
Ejaculatory and Orgasmic Dysfunction Registry
The objective of the current study is to create a large, national registry designed to capture key outcomes for men being treated for ejaculatory and/or orgasmic dysfunction. To accomplish this registry, CURE PD has partnered with the Sexual Medicine Society of North America (SMSNA) to help inform sexual medicine providers of the existence of the study and to help encourage patients to enroll. Subjects meeting criteria will be offered study entry by their local provider who will refer them to an email address to indicate their interest. Participants will then be administered questionnaires at baseline and every 3 months x 1 year, followed by every 6 months x 2 years. Patient partners will also be allowed to enroll and will receive questionnaires on the same schedule (baseline, q3 months x 1 year, q6 months x 2 years).
Phase
N/ASpan
261 weeksSponsor
Charitable Union for the Research and Education of Peyronie's DiseaseOrem, Utah
Recruiting
Healthy Volunteers
Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
The current study would prospectively follow 40 men through the following treatment protocol: - Men would receive 4 series of CCH injections according to the protocol below, which represents a modified version of our most recently published technique.13 - Medication administered on back-to-back days - Total of 0.9 mg administered with each series, diluted to 0.8 mL - Mild in-office modeling performed on treatment day 2 of each series - Wraps performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising - Sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series. - Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final series. - Note that men may stop sooner if they are satisfied before completing the 4 series. - If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol. - This would be performed 9-12 months after the 4th series of injections. - The technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial. - The men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total. At the time of initial enrollment, partners of study participants will be invited to enroll in the study and will be administered non-validated questionnaires designed to assess the partner's overall support for the ongoing treatment protocol. Assessments and study questionnaires will be administered at baseline, with the 1st injection of each series, 6 weeks after completing the 4th series of CCH injections, and 1 year after completion of the final series of CCH injections.
Phase
4Span
264 weeksSponsor
Charitable Union for the Research and Education of Peyronie's DiseaseOrem, Utah
Recruiting
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Background and Preliminary Data The treatment of prostate cancer results in several known sexual dysfunctions/risks, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Although all forms of prostate cancer treatment are associated with many of these changes, prostatectomy currently has the most data available on sexual function outcomes. Among the dysfunctions, erectile dysfunction has remained a very challenging adverse effect without effective preventative therapies. Specifically, prior randomized controlled trials evaluating the efficacy of PDE5 inhibitors (vardenafil and tadalafil) have failed to demonstrate improved erectile function preservation post-operatively. Recently, out team conducted a single-center randomized, controlled trial evaluating the efficacy of a novel penile traction therapy (PTT) device, RestoreX at preventing penile length loss post-prostatectomy. In addition to meeting the primary outcome of achieving improved penile length compared to controls, the study unexpectedly demonstrated improvements in erectile function in the treatment group compared to controls. Results were also consistent with two other prior randomized, controlled trials, one of which demonstrated improved erectile function in men with Peyronie's Disease and the other in men with diabetes mellitus (unpublished). As these findings represent the first known therapy which resulted in preserved erectile function post-prostatectomy, we sought to perform a larger, multi-center study in an attempt to confirm or refute findings. Investigational Device RestoreX is a PTT device developed by PathRight Medical using technology licensed from the Mayo Clinic. The device is classified as class I (orthotic) and does not require clinical trials to prove safety or efficacy. Mayo Clinic has previously performed 3 randomized controlled trials which have confirmed the safety of the device as well as efficacy in improving erectile function and penile length in various cohorts of men. The device has two functional aspects. The first is the ability to provide direct traction on the penis. The second is the ability to provide counter-bending forces, to treat conditions such as Peyronie's disease (bent penis). In the current study, only the direct traction aspects of the device will be utilized. Study Rationale PTT with Restorex has been shown to improve erectile function in several clinical scenarios, including in men with Peyronie's disease, men with diabetes mellitus (unpublished), and post-prostatectomy. As no therapy has ever been shown to improve erectile function or prevent loss of erectile function post-prostatectomy, we felt that there was significant clinical value in performing a large, multi-center, randomized, controlled trial to affirm or refute the efficacy of Restorex PTT in preserving erectile function post-prostatectomy. Potential Benefits There are several anticipated benefits to using PTT following prostatectomy. As loss of penile length results in several issues including loss of sexual function, cosmetic concerns, and difficulty in maintaining hygiene (incontinence resulting in yeast infections), the ability to maintain or restore length post-prostatectomy may mitigate these issues. Our team has previously demonstrated that Restorex PTT significantly improved penile length post-prostatectomy. Although this is an anticipated beneficial effect of therapy, we will not be specifically evaluating this outcome in the current study. In addition to improved penile length, our prior investigations have demonstrated preserved erectile function in men who received PTT with Restorex post-prostatectomy compared to controls. And among all patients in the three prior randomized, controlled trials evaluating Restorex, no significant or long-term adverse events were reported, highlighting the safety of the therapy. Anticipated Duration of the Clinical Investigation The overall study will be scheduled for 3 years, to permit adequate time for enrollment and follow-up. The intervention phase will include 5 months of randomized treatment (for the treatment arm), and 3 months of open label treatment (for all arms).
Phase
N/ASpan
444 weeksSponsor
Charitable Union for the Research and Education of Peyronie's DiseaseOrem, Utah
Recruiting
Adaptation and Pilot Implementation of ePNa Clinical Decision Support for Utah Urgent Care Clinics
Clinicians' ability to accurately diagnose pneumonia and then choose the most appropriate treatment options is enhanced by well-designed clinical decision support (CDS). Pneumonia CDS has historically been focused on inpatient settings, but ambulatory care settings with high pneumonia patient volumes also might benefit. The investigators propose to adapt an innovative, validated emergency department (ED) CDS tool based on consensus guidelines for pneumonia care (ePNa) and deploy it to urgent care centers (UCC) using the CFIR framework. Electronic tools such as ePNa may become even more useful within UCCs as the COVID-19 pandemic evolves, since recommendations can be readily updated as better methods of diagnosis and effective treatment develop. ePNa within the ED has already been adapted to recommend SARS-coV-2 testing for patients with pneumonia and signs and symptoms characteristic of viral pneumonia. The proposal supports four aims: 1. Adapt ePNa for UCC and after in silico testing, pilot it among "super user" clinicians during UCC shifts and assess its usability. ePNa needs adaptation for more limited patient data available in UCCs, calibration of severity measures for lower observed mortality, and a chest imaging prompt in patients with pneumonia signs and symptoms. ePNa for UCC will incorporate Stanford University's artificial intelligence CheXED model to provide electronic classification of chest images in <10 seconds for elements of pneumonia diagnosis and treatment (radiographic pneumonia, single vs multiple lobes, and pleural effusion). 2. Using the CFIR framework, our prior ED implementation experience, a focus group of UCC clinicians, semi-structured interviews, and direct observations of workflow including ePNa guided transitions of care between clinicians, the investigators will identify barriers and facilitators to adaptation and implementation of ePNa to UCCs. 3. Test the implementation strategy by deploying ePNa at one of two randomly chosen Intermountain Healthcare UCC clusters each with about 800 annual pneumonia patients - the other a usual care control. 4. Co-primary outcomes are a) accuracy of pneumonia diagnosis defined by compatible chief complaint plus ≥ 1 pneumonia sign/symptom and radiographic confirmation will be ≥10% higher in the ePNa cluster, and b) the percent of UCC pneumonia patients transferred to an emergency department for further evaluation will decrease by ≥ 3% in the ePNa cluster replaced by more direct hospital admissions or discharge home. Safety measures will be unplanned subsequent 7-day ED visits/hospitalizations and 30-day mortality. Based on this rigorous pilot study, the investigators anticipate a subsequent multi-system cluster-randomized trial. Our work incorporates the Five Rights of CDS to ensure that the strengths of this technology are optimized in the clinical environment. The investigators will leverage experience in innovative pneumonia research, pioneering CDS, and implementation science available at Intermountain to successfully complete this proposal.
Phase
N/ASpan
203 weeksSponsor
Intermountain Health Care, Inc.Orem, Utah
Recruiting
Healthy Volunteers
Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Phase
3Span
117 weeksSponsor
SanofiOrem, Utah
Recruiting
Healthy Volunteers
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
The study will enroll approximately 140 subjects randomized to dose regimens of 80 µg or 120 µg BCXL501 or placebo (Group one), or 60 µg BCXL501 or placebo (Group two; Europe only). Subjects with acute agitation will include male and female children and adolescents who are either newly admitted to a hospital setting or already admitted and experiencing acute agitation. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.
Phase
1Span
279 weeksSponsor
BioXcel Therapeutics IncOrem, Utah
Recruiting