Treatment Trials

155 Clinical Trials for Various Conditions

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COMPLETED
The Use of Videoconferencing for Monitoring of Patients Post Urologic Surgery
Description

Our study would be the first randomized study investigating the use of video conferencing via tablet computers versus traditional bedside rounding and its effect on clinical data such as length of stay and complications as well as patient satisfaction. As technology improves, medicine has an obligation to incorporate this technology to improve efficiency and cost-effectiveness. If telerounding is proven to not change outcomes or patient satisfaction, it saves time for the physician during office hours to see more patients or be productive in other ways. Telerounding could be applied in remote areas with a dearth of specialists, allowing these specialists' expertise to reach areas it could not before.

Conditions
RECRUITING
Pivotal Study of Voro Urologic Scaffold
Description

The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm. The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.

RECRUITING
Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
Description

The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for urologic bowel diversion patient education. Using a randomized two group design, we aim to determine whether the use of this model enhances patient knowledge, self-care skills, and confidence in ostomy care. We will also evaluate changes in quality of life (QOL) and patient satisfaction comparing patients exposed to the 3D model to those receiving standard of care. The secondary aim of the study is to examine the differences between groups on patient outcomes including hospital duration, mortality, emergency/urgent health care visits, readmissions, and infections. Participants will be educated using 3D model simulation as part of their preoperative education (experimental group) or have standard education without using the simulation model (comparator group). Both groups will complete quality of life (QOL), ostomy adjustment, and satisfaction with education surveys during their preoperative education visit and again during their routine follow-up visits (a) within 3 weeks after surgery, (b) between 5- 8 weeks after surgery, and (c) at approximately 3 months after surgery.

COMPLETED
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Description

This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.

COMPLETED
Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones
Description

The purpose of this study is to collect descriptive performance data using the MONARCH Platform, Urology (a novel robotic device) to perform mini-percutaneous nephrolithotomy (kidney stone removal) procedures. Data gathered from this study will be used to optimize the robotic platform and inform training and education material for the future users.

Conditions
RECRUITING
A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
Description

This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.

Conditions
RECRUITING
Preop Laxatives in Robotic Urologic Surgery
Description

Minimally-invasive surgery, either laparoscopic or robotic, is commonly used in urology. Several urologic procedures including prostatectomy, radical nephrectomy, and partial nephrectomy are now commonly performed robotically. Patients undergoing these procedures often have delayed return of bowel function and persistent gastrointestinal symptoms including nausea/vomiting, abdominal distension, and bloating for several days to weeks after surgery. Postoperative stool softeners and laxatives are routinely used in an effort to minimize these symptoms, with varying degrees of success. The aim of this study will be to evaluate whether the use of a preoperative osmotic laxative will be beneficial in improving recovery of bowel function and alleviating postoperative gastrointestinal complaints in patients undergoing these procedures. Patients will be randomized to either receive or not receive three days of polyethylene glycol (PEG, also known as MiraLAX) on the three days before surgery. Patients in both groups will receive the same postoperative bowel regimen including scheduled PEG both in the hospital and upon discharge until first bowel movement. Patients will be given a questionnaire and diary to record their postoperative gastrointestinal symptoms and time to first bowel movement. These questionnaires and diaries will then be analyzed to determine differences in time to first bowel movement and gastrointestinal complaints during their recovery from surgery.

ACTIVE_NOT_RECRUITING
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Description

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

COMPLETED
Surgical Patient Education in Pediatric Urology
Description

Randomized study to assess the impact of supplemental educational YouTube videos on postoperative healthcare utilization following ambulatory pediatric urologic surgery

COMPLETED
Perioperative Glucose and Insulin Changes in Major Urologic Surgeries
Description

Urological surgery patients will have their blood glucose measured before, during, and after surgery. Blood glucose will be measured using a continuous glucose monitor (CGM) device. We hypothesize the presence of a hyperglycemic state towards the end of surgery due to increased metabolic demand.

RECRUITING
Urologic Lymphadenectomy in AMIGO
Description

This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, to simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes) in patients with urological cancer.

COMPLETED
Preoperative Guided Imagery in Patients Undergoing Urologic Surgery
Description

This is a prospective randomized controlled trial of patients undergoing major urologic-oncologic surgery at the University of California, San Francisco (UCSF) Medical Center and the Helen Diller Family Comprehensive Cancer Center. This clinical trial examines the effect of guided meditation before surgery on the levels of anxiety, stress, sleep disturbance, and quality of life among patients scheduled to undergo a major urologic surgery for cancer. A cancer diagnosis and the treatments associated with it can be very stressful for patients, leading to depression, sleep disturbances, and lower quality of life. Mind-body practices such as guided meditation have been used for thousands of years to reduce the effects of chronic stress and to improve quality of life. This clinical trial examines the effects of guided meditation on the stress, depression, and quality of life levels of patients undergoing urologic surgery for their cancer.

Conditions
COMPLETED
A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
Description

The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).

TERMINATED
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
Description

This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.

ACTIVE_NOT_RECRUITING
Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
Description

This registry will evaluate treatment selection for patients with newly diagnosed, localized prostate cancer following Prolaris testing. It will measure the proportion of men who initially select treatment with active surveillance, the time frame between active surveillance selection and any change in treatment, and clinical outcomes.

Conditions
RECRUITING
Exercise in Patients Undergoing Urologic Surgery
Description

Patients who are being scheduled for an operative procedure with an inpatient postoperative stay are eligible for this study. Participants will be selected to start a physical fitness plan or a nutrition plan at the time of surgical scheduling. Each participant will be asked to continue their current lifestyle for two days after their pre-operative appointment to get a baseline of activity (by pedometer and functional tests) and nutritional risk (by questionnaire). After two days, patients in the activity group will start their activity plans. They will be encouraged to get 10,000 steps per day and to perform whole body strength training exercises 3 times a week. Five days before and after surgery, participants in the nutrition group will be asked to consume a standard liquid nutrition supplement (i.e. Boost or Ensure) two times per day. Participants in the activity group will record steps and number of strength training sessions completed, while patients in the nutrition group will record the number of supplements consumed.

TERMINATED
Effect of Perioperative Intravenous Lidocaine Infusion in Robotic-Assisted Urologic Surgery
Description

Controlling pain is fundamental during and after surgical procedures. This study examines pain associated with robotic assisted surgery on prostate cancer or a kidney mass. In recent years, the risk of opioids in the postoperative period has gained interest due to the growing epidemic of addiction, dependence, and overdose. In this study, the investigators expect a continuous infusion of intravenous lidocaine during the perioperative period to result in less pain and less opioid use.

COMPLETED
Urology San Antonio MRI/MicroUS Comparison
Description

This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.

Conditions
COMPLETED
Pain Management in Outpatient Urologic Procedures
Description

Goal of this study is to evaluate how pain is controlled after outpatient urologic surgeries. Patients will receive either opioid pain medication or non-opioid medication for pain control. A survey will be conducted at the post-operative appointment to evaluate for pain control.

TERMINATED
Prosthetics Registry and Outcomes in Urology at Duke
Description

To establish the Prosthetics Registry and Outcomes in Urology at Duke (PROUD) which will serve as a retro- and prospective data repository that our team will use to optimize patient satisfaction, lower cost and reduce morbidity associated with penile prosthesis implantation. The study team will collect retrospective data from subjects at Duke University and Duke Raleigh Hospitals who have undergone genitourinary prosthesis implantation from January 1, 1996 onward. Prospective data will only be collected from patients seeking care with Dr. Lentz in Duke Raleigh.

ACTIVE_NOT_RECRUITING
Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
Description

The purpose of this research study is to evaluate an Enhanced Recovery After Surgery (ERAS) protocol in children and young adults undergoing urologic reconstructive surgery. The investigators plan to collect data on speed of recovery (how quickly pain improves, length of time in the hospital, and the need for additional pain control) on patients who receive care under the ERAS protocol and compare it to historical controls.

RECRUITING
Prospective Cohort of Transitional Urology Patients
Description

A transitional Urology database was created in parallel with National Spina Bifida registry to follow patients with complex congenital urogenital anomalies and be able to prospectively evaluate them. The investigators obtained the standardized questionnaires to collect long-term data regarding patients' genitourinary status including urine and fecal continence, sexuality, fertility, and pelvic health.

COMPLETED
Urology of Virginia Case Series
Description

The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer. The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI). These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy. In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.

WITHDRAWN
Microbiome of Urologic Chronic Pelvic Pain Syndrome
Description

This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).

COMPLETED
Trans-MAPP II Study of Urologic Chronic Pelvin Pain
Description

The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) to focus on a broader approach to the study of Interstitial Cystitis (IC)/ Bladder Pain Syndrome (BPS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken. Patients with IC or CP are being recruited for a new study called the "Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS). This research study will recruit Control Participants to better understand the symptoms of individuals with some form of IC or CP. As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often not helpful. The goal of this study is to better understand how pain is felt in people with IC or CP and the investigators hope that this study will lead to improvement in the treatment of IC and CP.

COMPLETED
Percutaneous Externally-Assembled Laparoscopic Urologic Surgery
Description

This will be a single-arm prospective internally-controlled study. Patients will undergo percutaneous externally-assembled laparoscopic surgery where one or more 3 mm instruments are added or substituted for conventional 5 or 10 mm trocars.

COMPLETED
Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Description

A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.

COMPLETED
Efficacy of Liposomal Bupivacaine Versus 0.25% Bupivacaine for Laparoscopic Urologic Surgery
Description

A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic urologic surgeries in an effort to determine which method reduced postoperative opioid use the most.

WITHDRAWN
Effects of Massage on Post-operative Pain in Urologic Patients
Description

The purpose of this study is to determine the effect that receiving massage therapy post-operatively has on reducing perceived anxiety and pain in urology patients. Secondarily, the result of massage on patient satisfaction, length of hospital stay, and narcotic use will also be studied.

COMPLETED
Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions
Description

To evaluate for any adverse effects that may be related to the administration and reception of autologous adipose derived stromal vascular fraction (SVF). Secondarily, the study monitors the results of subjective and objective findings as it applies to the non-blinded deployment of autologous SVF for various inflammatory and/or degenerative conditions including select orthopedic, neurologic, urologic and cardio-pulmonary conditions. SVF deployments include intra-venous, intra-articular, and soft tissue injections.