In addition to research on spinal cord injury, acquired brain injury and multiple sclerosis, Shepherd Center also conducts research on the following topics:

The following is a summary of current research initiatives.

Effect of Pulsing Electromagnetic Fields on Low Back Pain of At Least 3 Months Duration: A Pilot Study (Healthonics; Randy Rizor, MD, Shepherd Center) [353]

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial Cystitis (Alza; Jenelle E. Foote, MD, Shepherd Center) [286]

Prevention of urinary tract infections in persons with spinal cord injury (NIH; Bruce Greene, MD, Urology, Shepherd Center) [303]

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer (GlaxoSmithKline; Wylly Killorin, MD, Shepherd Center) [310]

Efficacy and Safety of Oxybutynin Transdermal Systems in Patients with Neurogenic Overactive Bladder Resulting from Spinal Cord Injury – A Multi-Center, Open Label, Dose Titration Pilot Study(Jenelle Foote, MD, Shepherd Center) [335]

A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Dosing Regimens to MN-001 in Patients with Interstitial Cystitis(Medicinova Paragon; Jenelle Foote, MD, Shepherd Center) [352]

A 12-week, randomized, open-label, parallel-group, multicenter study to evaluate the efficacy, safety and tolerability of Enablex® (darifenacin) (with voluntary up-titration from 7.5mg o.d. to 15mg o.d. at week 2) alone or in combination with Behavioral Modification Program for symptoms of overactive bladder(Novartis; Jenelle Foote, MD, Shepherd Center) [354]

Initial Assessment of the Performance of Prototype Non-Latex Male External Catheters (MEC) in a User Population (Hollister, Inc., Sherri Hudson Martin, CURN, CCRC, Dianne McPherson) [362]

A randomized, double-blind, placebo-controlled study to evaluate the effects of GW679769 on Current Perception Threshold (CPT) following a single 150 mg dose (Part A) and to evaluate the effect on CPT and symptoms of overactive bladder following 28 days of repeat dosing with 120 mg GW679769 administered once daily (Part B) in patients with neurogenic bladder due to incomplete spinal cord injury (Bruce Green, MD, Paul Alphonse, MD) [363]

A Twelve-Week Randomized, Double-Blind, Placebo-Cotrolled, Parallel Group, Forced Titration, Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs. Placebo in Women with Overactive Bladder (Edward Wylly Killorin, MD, Bruce Green, MD) [373]

User Assessment of Effective Adhesive Coating Weight for a Non-Latex Male External Catheter (MEC) Prototype (Sherri Hudson Martin, RN, Dianne McPherson) [377]

Effect of Pulsing Electromagnetic Fields on Low Back Pain of At Least 3 Months Duration: A Pilot Study (Healthonics; Randy Rizor, MD, Shepherd Center) [353]

The purpose of this study is to demonstrate that in a population of chronic low back pain patients, the MedRelief SE-55 device can reduce the pain and lessen the need for medications. Patients with chronic low back pain lasting for 3 months or longer have on-going pain that often requires relief by pain medications. The MedRelief SE-55, bioelectrical stimulation device is FDA approved for relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. After successfully completing the entry evaluation, the patient will undergo an assessment by the investigator/coordinator, and the Physician Pre Data Form will be completed. If the volunteer is eligible and willing to participate, the subject will be enrolled into the study. If, while screening, the volunteer exhibits any of the exclusion criteria, or lacks any of the inclusion criteria, the screening will stop and the volunteer will be excluded from the study. Treatment will be for 28 days. Data from this study will help guide the design of a larger placebo controlled study. The primary outcomes are to determine pain relief following treatment with MedRelief SE-55 and the function and pain reduction in values from baseline. The secondary outcomes are to determine treatment affect on pain, medication use and quality of life.

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial Cystitis (Alza; Jenelle E. Foote, MD, Shepherd Center) [286]

The purpose of this study is to evaluate the safety and effectiveness of two different daily oral doses of Elmiron in participants with interstitial cystitis. The lowest effective and safe dose of Elmiron is not known for subjects with interstital cystitis. Elmiron 100mg once a day is being compared against the usual dose of three times a day and placebo.

Prevention of urinary tract infections in persons with spinal cord injury (NIH; Bruce Greene, MD, Urology, Shepherd Center) [303]

The purpose of this one-year study is to determine if introducing benign bacteria into the bladder decreases the frequency of urinary tract infections. Subjects will submit to a history and physical exam with labs (serum creatinine and urine culture), and x-ray of the abdomen (KUB). A renal ultrasound and urodynamics are required unless done within the last year. Antibiotics may be administered. A urinary catheter will be placed into the bladder to allow the entry of a saline solution or E. coli 83972 inoculating solution. Participation in this study will last approximately 12 months. The schedule of activity will include a medical and urological history, with a subsequent visit, for a physical exam and recording of any antibiotic use, urodynamics (if not done within the last 12 months), renal ultrasound, urinary sterilization through the use of oral antibiotics, randomization, recording of any symptoms of an infection, vital signs taken, bladder catheterization, the obtaining of a urine sample for urinalysis and culture, and a Quality of Life Scale. Other visits will include a bladder inoculation, vital signs, bladder catheterization, a urine sample for a urine culture, recording of any symptoms of an infection and antibiotic use, and recording of adverse events, and a quarterly Quality of Life Scale.

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer (GlaxoSmithKline; Wylly Killorin, MD, Shepherd Center) [310]

The primary objective of this 4 year study is to assess the effects of Dutasteride 0.5mg compared to placebo on the risk of biopsy-detectable carcinoma of the prostate after 2 years and 4 years of treatment. Secondary objectives are to assess the effects of Dutasteride compared to placebo with regard to safety and tolerability, clinical and histopathological effects, benign prostatic hyperplasia (BPH) symptoms, effects on serum testosterone, dihydrotestosterone, free and total prostate specific antigen, and health outcome measures. In order to participate in the study, the subject must have had only one previous negative prostate biopsy within the last six months prior to the screening date.

Efficacy and Safety of Oxybutynin Transdermal Systems in Patients with Neurogenic Overactive Bladder Resulting from Spinal Cord Injury – A Multi-Center, Open Label, Dose Titration Pilot Study (Jenelle Foote, MD, Shepherd Center) [335]

The primary objective of this study is to evaluate the efficacy of Oxybutynin TDS at doses up to 11.7mg/day, in reducing leaking accidents between scheduled catheterizations in adult patients with neurogenic overactive bladder resulting from a spinal cord injury. This will be measured by the change from baseline to the end of the Dose Titration Period (Week 8) in the average number of catheterizations per day without leakages as collected in a 3 – day urinary diary. The secondary objectives are to evaluate treatment safety; changes in urodynamic parameters, quality of life, patient satisfaction, number of catheterizations per day, percent of patients achieving complete continence between scheduled catheterizations; TDS adhesion; and Oxybutynin and N-DEO plasma concentrations. The purpose of this research study is to determine the effectiveness and the safety of transdermal oxybutynin (Oxytrol) for treating a condition known as neurogenic overactive bladder caused by a spinal cord injury. Because the bladder's function is controlled by nerves contained in the spinal cord, spinal cord injuries often result in loss of control and normal function of the bladder, resulting in incontinence and increased risks of urinary tract infections and kidney damage. Standard treatment for neurogenic overactive bladder is to use clean intermittent catheterization (CIC). In addition to CIC, some people also take a medication, such as oxybutynin, to help decrease the number wetting of accidents that may happen each day. The reason why the study is being done is to see if the transdermal delivery (patch) of oxybutynin will decrease the number of times each day there is urine leakage between catheterizations. In this study, oxybutynin is put in a patch that is worn on the stomach, hip or buttocks. Four doses of Oxybutynin will be looked at in this study: 3.9 mg/day, 7.8 mg/day, 9.1 mg/day and 11.7 mg/day.

A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Dosing Regimens to MN-001 in Patients with Interstitial Cystitis (Medicinova Paragon; Jenelle Foote, MD, Shepherd Center) [352]

Interstitial Cystitis (IC) is a condition of the bladder tissue being irritated. IC results in recurrent bladder and pelvic pain, urinary frequency and urgency. It is believed to affect approximately 700,000 Americans, 90% of them are women. Current treatments are aimed at relieving symptoms since the exact cause of IC is unknown and include irrigations of the bladder with anesthetics, or using the oral drug Elmiron which is believed to assist in the rebuilding of the epithelium in the bladder. This study is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of two different doses of an oral drug. This drug produces anti-inflammatory activity. Subjects that report symptoms of IC will be screened and within 7 to 9 days be randomized in a 1:1:1 ratio to receive either 500mg of the oral drug daily or 500 mg of the drug twice daily or placebo. Subjects will be given drug at the baseline (visit 2) and in 28 days (visit 3). There will be a phone visit at week 6 (42 days after baseline). The final visit (visit 4) will be at 56 days after baseline. Safety assessments will include adverse events, physical exams, laboratory testing, and vital signs. Efficacy assessments include subject responses on the Global Response Assessment (GRA), Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale, and the O'Leary Sant IC Symptom and Problem Index.

A 12-week, randomized, open-label, parallel-group, multicenter study to evaluate the efficacy, safety and tolerability of Enablex® (darifenacin) (with voluntary up-titration from 7.5mg o.d. to 15mg o.d. at week 2) alone or in combination with Behavioral Modification Program for symptoms of overactive bladder (Novartis; Jenelle Foote, MD, Shepherd Center) [354]

This study is designed to generate data on the treatment with Enablex® administered alone or in conjunction with behavioral modification therapies. The results should allow for refined understanding of overactive bladder (OAB) treatment options and, if appropriate, to modify, the current clinical practices in patients with OAB. Information gained from this study will be used to support educational materials. The primary objective of this study is to evaluate the efficacy of Enablex® (darifenacin 7.5 mg once a day, (o.d.) with voluntary up-titration to 15 mg o.d. at week 2) alone and Enablex® (darifenacin 7.5 mg o.d. with voluntary up-titration to 15 mg o.d. at week 2) in combination with Behavioral Modification Program on micturitions at the end of 12 weeks of treatment. The secondary objectives is to evaluate the efficacy of Enablex® (darifenacin 7.5 mg once a day, (o.d.) with voluntary up-titration to 15 mg o.d. at week 2) alone and Enablex® (darifenacin 7.5 mg o.d. with voluntary up-titration to 15 mg o.d. at week 2) in combination with Behavioral Modification Program on micturitions evaluated at weeks 2 and 6, urge urinary incontinence episodes, urgency episodes, urinary incontinence pads used and nocturnal voids due to overactive bladder. This program is designed to emphasize the physical control of lower urinary traction function and train patients to inhibit the sensation of urgency and postpone voiding as well as modifying their behavior to lessen the symptoms of OAB. The study requires 6 planned visits.

Initial Assessment of the Performance of Prototype Non-Latex Male External Catheters (MEC) in a User Population (Hollister, Inc., Sherri Hudson Martin, CURN, CCRC, Dianne McPherson) [362]

The primary objective is to assess performance as indicated by the ability of the catheter to remain in place and to function with a collection system. The primary hypothesis (Ho) is that there is no difference in probability of continued wear between the prototype and control device. Secondary objectives are to obtain perception of comfort during wear and upon removal. For each comparison, twenty-eight subjects are screened and enrolled to ensure completion with twenty-four. There is no intent to select or balance for circumcised vs. non-circumcised subjects. Each subject wears three each of the prototype and control devices for a total of six applications. Each device is self-applied and is worn for up to 28 (24± 4) hours. Participation by an individual subject is a maximum of seven days. The subject checks at approximately eight hour intervals for comfort and device security. No other change is made to their normal care. The subject completes an assessment form following the use of each device. If the subject experiences any unusual discomfort, and/or observes any irritation, and/or has difficulty urinating, he immediately removes the catheter and contacts the Investigator who determines whether the subject may continue or is withdrawn from the study.

A randomized, double-blind, placebo-controlled study to evaluate the effects of GW679769 on Current Perception Threshold (CPT) following a single 150 mg dose (Part A) and to evaluate the effect on CPT and symptoms of overactive bladder following 28 days of repeat dosing with 120 mg GW679769 administered once daily (Part B) in patients with neurogenic bladder due to incomplete spinal cord injury (Bruce Green, MD, Paul Alphonse, MD) [363]

The primary objective of the study is to assess the effect of GW679769 on Current Perception Threshold (CPT) in patients with neuorogenic overactive bladder(OAB) after a single 150 mg dose and after repeat dosing of 120 mg for 28 days. GW679769 may desensitize the bladder allowing increased capacity, attenuate the symptoms of frequency and urgency and prohibit detrusor overactivity that cause incontinence. The principal investigator or his designee will discuss the study, its requirements, alternative treatments and restrictions with the patient. Written informed consent will be obtained prior to any research related procedures. Patients will be screened within 30 days prior to administration of study medication ensuring they meet entry criteria.

A Twelve-Week Randomized, Double-Blind, Placebo-Cotrolled, Parallel Group, Forced Titration, Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs. Placebo in Women with Overactive Bladder (Edward Wylly Killorin, MD, Bruce Green, MD) [373]

The primary objective of this study is to compare the efficacy of GW679769 administered once daily for 12 weeks (60 mg for six weeks, followed by 120 mg for six weeks) and placebo in female subjects with overactive bladder. The secondary objectives are: To evaluate the safety and tolerability of GW679769 administered once daily for 12 weeks (60 mg for six weeks) compared to that of placebo in female subjects with overactive bladder. To describe the exposure of both GW679769 and its primary metabolite (GSK525060) after 12 weeks of dosing (60 mg for six weeks) compared to that of placebo in female subjects with overactive bladder. To explore the relationship of GW679769 and its primary metabolite GSK525060 with clinical response/safety after 12 weeks of dosing (60 mg for six weeks) compared to that of placebo in female subjects with overactive bladder.

User Assessment of Effective Adhesive Coating Weight for a Non-Latex Male External Catheter (MEC) Prototype (Sherri Hudson Martin, RN, Dianne McPherson) [377]

Urinary incontinence is a common disorder among men with conditions such as prostate problems, SCI, spina bifida, and multiple sclerosis. There is a desire to reduce latex exposure from medical devices while retaining the material properties of latex. A thermoplastic elastomer, Monprene®, has been identified as a potential replacement material. The test devices are prototypes constructed of Monprene® and a medical grade adhesive from the Duro-Tak family. The objective of this study is to determine if a lower coating weight than previously used performs as well as the control in terms of wear time and leakage. The effective coating weight is determined by the interpretation of data acquired from the study. The primary hypothesis is that there is no difference in probability of continued wear and leakage between each prototype and the control. The secondary objectives are to obtain perception of ease of application and removal of the device.