The effect of early versus late urinary catheter removal on post-operative urinary retention (POUR) and catheter-associated urinary tract infection (CAUTI) rates in patients with POUR risk factors receiving thoracic epidural analgesia (TEA) for post-operative thoracic surgery pain control Save

Date Added
November 15th, 2016
PRO Number
Pro00058458
Researcher
Michaella Prasad
Keywords
Bladder, Infectious Diseases, Pain, Spinal Cord, Surgery, Urinary
Summary

Patients scheduled for thoracic surgery will be identified as potential candidates and recruited by a research coordinator before surgery. Research subjects will be randomized to either early or late post-operative urinary catheter (a thin flexible tube placed into the bladder to drain urine) removal. Thoracic epidural analgesia (TEA), a thin tube placed near the spinal cord, will remain functioning after urinary catheter removal for the early group. The study group randomized to early catheter removal will have urinary catheters removed 24 hours after surgery is completed. Study subjects that are randomized to late removal of urinary catheter will have urinary catheters removed after TEA is discontinued as routine clinical care (usually 4-5 days). Determination of bladder urine volume will be made by sound wave examination (ultrasound) by appropriately-trained staff. Following indwelling urinary catheter removal, research subjects may receive a brief urine drain tube as standard clinical care. Laboratory urine analysis will be obtained from urine following removal of urinary catheter and assessed for urinary tract infection (UTI).

Institution
MUSC
Recruitment Contact
Bill Rawls
9196360725
rawlsw@musc.edu

A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS Save

Date Added
August 9th, 2016
PRO Number
Pro00058027
Researcher
Lindsey Cox
Keywords
Bladder, Multiple Sclerosis, Spinal Cord
Summary

The main objective of this study is to evaluate if Dysport® is effective and safe for the treatment of urinary incontinence due to NDO.

Dysport® contains a toxin that is produced from bacteria. The toxin is called Botulinum toxin A and it is known that this toxin causes muscles that are contracting too much to relax once the muscles are injected with the toxin. This relaxation usually lasts for several months before treatment needs to be given again.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
843792-2325

A Phase 2a, Biphasic Adaptive Design Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared with the Individual Components Lidocaine and Heparin in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Save

Date Added
February 9th, 2016
PRO Number
Pro00046798
Researcher
Eric Rovner
Keywords
Bladder
Summary

The purpose of this research study is to determine whether the study drug is safe and effective in controlling bladder pain in patients with Bladder Pain Syndrome / Interstitial Cystitis. The study drug, URG101, is an experimental drug that is being tested to see if it is effective in treating bladder pain. During this research study, you will be randomly assigned (like pulling a number from a hat) to either receive the study drug URG101 (a mixture of Lidocaine and Heparin), lidocaine alone, heparin alone, or a placebo. A placebo is a product that is made to look like the study drug, but contains no medication (like a sugar pill). In this study the placebo is the phosphate solution without lidocaine or heparin mixed in it. If you participate in this study during the run-in phase, you will have a 1 in 6 chance of receiving placebo during the research study and a 1 in 6 chance of receiving heparin alone. You will have a 1 in 3 chance of receiving lidocaine alone and a 1 in 3 chance of receiving the study drug (URG101). Your participation in this research study will last for approximately 3 days including a follow-up phone call 48 or 72 hours after receiving the study drug.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

Long-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 8 to 17 Years of Age Save

Date Added
July 9th, 2013
PRO Number
Pro00024164
Researcher
Andrew Stec
Keywords
Bladder, Pediatrics, Urinary
Summary

This is a multicenter study is to investigate the long-term safety and effectiveness of BOTOX® injections into the bladder of children that have accidental loss of urine due to neurogenic detrusor overactivity (NDO). Approximately 100 subjects will participate in this study. Patients have to have completed the Allergan Study 191622-120 and be qualified to be retreated.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 8 to 17 Years of Age Save

Date Added
June 25th, 2013
PRO Number
Pro00024123
Researcher
Andrew Stec
Keywords
Bladder, Pediatrics, Urinary
Summary

This is a multicenter, randomized, double-blind, parallel group study to evaluate the efficacy and safety of BOTOX in patients with urinary incontinence due to neurogenic detrusor overactivity who are 8 to 17 years of age. Patients will be evaluated during a screening period for eligibility. Eligible patients will be randomized and receive treatment on day 1.Patients will have posttreatment follow-up clinic visits at weeks 2, 6, and 12. Thereafter, patients will have alternating telephone and clinic follow-up visits every 6 weeks until they exit the study. Patients exit the study once they qualify for retreatment, or at week 48 if the patient never qualifies for retreatment. Request for retreatment can occur at any scheduled clinic or telephone visit or between scheduled visits from week 12 onwards. If the patient qualifies for retreatment they will exit the study, so the visit at which the patient qualifies for retreatment will also become the exit visit..

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Cemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma Save

Date Added
March 7th, 2011
IRB Number
20167
Researcher
Michael Lilly
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Urinary
Summary

The purpose of this study is to compare the effects, good and/or bad, of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on you and your transitional cell cancer to find out which is better. Bevacizumab is an antibody that we think can block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.

Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing and are expected to be very similar in safety and effectiveness. The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being done to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of your cancer and allow you to live longer.

This is a randomized trial so patients will receive one of two treatments: Arm A: Gemcitabine, cisplatin, and placebo (sugar water or salt water)OR Arm B: Gemcitabine, cisplatin, and bevacizumab (an experimental drug). Arm A is the current standard treatment for patients with this type of cancer. Your participation in this trial will continue for as long the cancer is responding to or is stabilized by the drugs and you do not have any severe side effects from the drugs.

Institution
MUSC
Recruitment Contact
Alan Brisendine
843-792-9007
matsont@musc.edu

A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy Save

Date Added
October 5th, 2009
IRB Number
19018
Researcher
David Marshall
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Urinary
Summary

The purpose of this study is to find out what effects (good and/or bad) chemotherapy combined with external radiation therapy and possible removal of your bladder has on you and your cancer. The chemotherapy drugs used in this study (5-Fluorouracil, cisplatin, and gemcitabine) are not experimental drugs. This research is being done because we do not know whether one combination of drugs with radiation is superior to another in the treatment of your disease. This study uses similar therapies to the standard treatment, but chemotherapy and radiation therapy are given before removal of the bladder is considered. In this study, bladder removal is advised if, after chemotherapy and radiation, your tumor has not completely disappeared, if your tumor comes back, or if it gets larger.

Patients who participate in this trial will be randomized into two groups. Patients will receive either cisplatin and 5-FU chemotherapy and radiation twice per day OR gemcitabine chemotherapy and radiation once per day. Participation in this study may last up to 8 months with continued follow up after treatment is complete.

Institution
MUSC
Recruitment Contact
Alan Brisendine
843-792-9007
brisend@musc.edu

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