Erectile Dysfunction

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 3/4 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

This research investigates a new self-administered digital application designed to improve sexual health, quality of life, and psychological distress among survivors of hematopoietic stem cell transplants (HCT). HCT survivors often face long-term sexual dysfunction due to complex biological, psychological, and social factors, which significantly affect their well-being and relationships. The study aims to address these challenges through a multidisciplinary approach delivered via a digital platform. Participants will be randomly assigned to either use the SHIFT digital application or receive enhanced usual care. The SHIFT app includes interactive features like gamification, survivor videos, intimacy exercises, and optional content to engage users over eight weeks. Those in the usual care group will meet with their clinicians and may be referred to specialists if needed but will not have access to the SHIFT app. During the study, participants will complete assessments measuring sexual satisfaction, function, quality of life, anxiety, and depression at various points up to 24 weeks. Researchers will monitor global satisfaction with sex at week 8 as the primary outcome. The study involves medical evaluations and tracks psychological and physical health through questionnaires and scales, aiming to evaluate the impact of the digital intervention on sexual health outcomes and overall well-being in HCT survivors.

This research evaluates the use of low-intensity shockwave therapy (LI-SWT) as a treatment for men with erectile dysfunction (ED), a condition where it is difficult to achieve or maintain an erection firm enough for sex. The study aims to gather information on which patients benefit from this therapy to better predict outcomes and help guide treatment decisions. The device used has FDA clearance but is not yet approved specifically for ED treatment. Participants will receive six weekly sessions of LI-SWT using the UroGold100™ device, which applies shockwave energy to the penis and perineum. Before treatment, patients complete questionnaires, blood tests, and a non-invasive blood vessel function test with the EndoPAT device. Follow-up visits occur at 3, 6, and 12 months after the initial baseline visit, including additional questionnaires and safety surveys. During the study, researchers will monitor erectile function using the International Index of Erectile Dysfunction-Erectile Function Domain (IIEF-EFD) score, focusing on changes three months after treatment and durability of improvement at six and twelve months. Safety and any adverse effects will be assessed throughout. Total study participation includes baseline assessments, treatment sessions, and follow-up evaluations over one year.

Researchers are evaluating a new treatment called ST-04, a mucoadhesive intraurethral polymer suspension of alprostadil, for adult males with erectile dysfunction (ED). This Phase 2 trial aims to assess the effectiveness of three different dose levels of ST-04, with or without sildenafil, to improve erectile function compared to the participants' baseline. ST-04 is designed to deliver alprostadil directly inside the urethra to promote penile tumescence and erection. Participants will receive up to three escalating doses of ST-04 over a 12-week period, with a maximum of 11 administrations. Dose levels include 500 mcg, 1000 mcg, and 1500 mcg of ST-04, which may be given with or without sildenafil. Each dose is dispersed along the urethra forming a hydrogel that adheres to the lining to achieve its effect. During the study, participants will undergo assessments including the International Index of Erectile Function (IIEF) questionnaire to measure changes in erectile function at baseline and 1 month after each dose level. Additional evaluations include the Erectile Hardness Scale, Sexual Encounter Profile, and the percentage of successful erection onset within 30 minutes of application. Safety will be monitored through the recording of adverse events. The total study duration includes up to 12 weeks of treatment with regular follow-up visits.

This research aims to evaluate if men can appropriately select and use tadalafil 5 mg tablets as an over-the-counter (OTC) treatment for erectile dysfunction. The study is an open-label actual use trial enrolling about 2,250 men who have symptoms of erectile dysfunction and are interested in OTC treatment. Approximately 1,000 participants are expected to proceed to the use phase based on their responses to a mandatory health survey assessment. Participants will take tadalafil 5 mg tablets orally, one tablet daily, while using a digital health survey tool. The study is conducted remotely via video interaction over a four-month period. It is designed as a single-arm open-label trial, focusing on real-world use of tadalafil as an OTC medication. During the study, researchers will monitor how well participants follow the recommended dosing intervals, their medical conditions, and any adverse events or care-seeking behaviors related to the use of tadalafil. Participants will complete health surveys, record their dosing and symptoms in electronic diaries, and be monitored for safety throughout the 4-month use phase plus a 30-day follow-up period. The main outcomes include adherence to dosing recommendations and appropriate use based on medical assessments.

Researchers are evaluating the impact of Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) compared to conventional abdominal laparoscopy (CAL) for benign adnexal surgery in women aged 18 to 70. The study aims to confirm that vNOTES does not negatively affect women's sexual function after surgery, addressing concerns about vaginal scarring and its effects on sexual activity. Secondary goals include assessing vNOTES efficiency, complications, and the quality of histological analysis of surgical specimens. Participants will be randomly assigned to receive either the vNOTES or CAL surgical technique for procedures such as cystectomy, oophorectomy, salpingectomy, or tubal sterilization. Both approaches involve minimally invasive surgery, with vNOTES using the vaginal route and CAL using abdominal laparoscopy. The study also examines pain, hospital stay length, patient satisfaction, and surgical complications during and up to 30 days after surgery. Women in the study will complete questionnaires before surgery and at 3 and 6 months afterward to assess sexual function, couple satisfaction, and pain during sex. Medical and general data will be collected at enrollment, during hospitalization, and one month post-surgery. The main outcomes measured include quality of sexual life and postoperative recovery, while monitoring safety and the effectiveness of both surgical methods throughout the study period.

Researchers are evaluating the effects of the web-based program OMGYES.com on sexual dysfunction in young adult female cancer survivors. This pilot trial aims to assess how feasible, acceptable, and appropriate the intervention is for this group. The study compares outcomes between participants who receive the intervention immediately and those who begin it after a period of observation. Participants will be assigned to one of two groups: an immediate intervention group that starts using OMGYES.com right after enrollment, and a delayed intervention group that undergoes 5 weeks of observation before starting the program. The intervention consists of completing online educational modules at home. During the study, participants will visit the clinic every 5 weeks to complete questionnaires assessing feasibility, acceptability, and appropriateness of the intervention using standardized measures. The main outcome will be measured at the end of the 6-week study period. The trial runs through November 2026 and involves young adult female cancer survivors aged 18 to 45 years.

Researchers are studying how blood samples collected through fingerstick (capillary) compare to traditional venous blood samples for lab testing. This observational study aims to understand the stability of capillary blood samples under different environmental conditions and over time to support the development of lab procedures. The study addresses the need for easier, less distressing blood collection methods to expand diagnostic access and improve disease monitoring remotely. Participants may collect capillary blood themselves or have venous blood drawn by healthcare professionals at designated facilities or their homes. Capillary samples are collected via fingerstick using a lancet, with up to four samples per visit, while venous samples are collected through standard venipuncture methods. Samples are then processed and analyzed under various conditions such as temperature, humidity, light exposure, and freeze-thaw cycles to evaluate specimen stability and assay reliability. Participants provide blood samples either during a single visit or multiple visits over time until withdrawal or study end. The study includes collection of health information and consent, with compensation upon sample submission. Researchers will assess the correlation between capillary and venous samples and monitor sample stability over several days. The study is designed with minimal risk, involving routine procedures and safety monitoring, continuing until study closure or participant withdrawal.

This research aims to evaluate whether the combined use of the EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices can improve depressive symptoms, sexual function, and urinary incontinence in women who are perimenopausal or postmenopausal, aged 40 years and older, without other medical causes. The study uses a prospective, multi-center, randomized, single-blinded design with two groups to assess safety and efficacy over approximately five months. Participants are randomly assigned in a 3:1 ratio to either an active treatment group or a sham treatment group. The active group receives six sessions of transcranial magnetic stimulation using the BTL-699-2 device over the left dorsolateral prefrontal cortex at intensities up to 70% of their motor threshold, and six treatments with the HPM-6000UF device applied to pelvic floor muscles at intensities up to 100%. The sham group receives similar procedures at minimal intensities (1%). Treatments are spaced 3 to 7 days apart. During the study, participants complete several assessments including the Patient Health Questionnaire-9, Hamilton Depression Rating Scale, Greene Climacteric Scale, International Consultation on Incontinence Questionnaire, Female Sexual Function Index, Warwick-Edinburgh Mental Wellbeing Scale, Columbia Suicide Severity Rating Scale, Therapy Comfort Questionnaire, and Subject Satisfaction Questionnaire. These are completed at baseline, during treatment, and at follow-ups 1 month and 3 months post-treatment. Researchers monitor changes in depressive symptoms, sexual function, urinary incontinence, mental well-being, therapy comfort, satisfaction, and any treatment-related adverse events.