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ONGOING TRIALS

NEUROGENIC BLADDER

Neurogenic bladder is a syndrome characterized by urinary urgency, frequency, with or without incontinence (involuntary loss of urine) associated with a neurologic disorder.

  • Do you have Multiple Sclerosis (MS) or have a Spinal Cord Injury (SCI)?
  • Do you find that your current bladder medication is not effective?
  • Do you still have incontinence, wear pads or diapers?
  • Are you exhausted not only from your disease, but from frequent trips to the bathroom?

There is a study being conducted to improve urinary incontinence for those suffering from MS or SCI.

OBJECTIVE:

To evaluate the safety and efficacy of a study medication or placebo injected into the bladder for the treatment of urinary incontinence in patients with MS or SCI who have not responded to oral therapies.

TRIAL QUALIFICATIONS:

  • 18-80 years of age
  • Male or female
  • Multiple Sclerosis or Spinal Cord Injured
  • Weigh >110 pounds
  • Walk independently or with minimal assistance
  • Must be able to complete a bladder diary and questionnaires
  • Must attend clinic visits with alternating phone visits

Duration of Trial: 1 year

All study related care, including physical exams and neurological evaluations are provided at no cost. Compensation is available.

For further details and to determine eligibility, please contact 716-631-9654.


NON-INVASIVE BLADDER CANCER

Bladder cancer is the seventh most common cancer worldwide, fourth in men and tenth in women. Transitional cell carcinomas or low grade tumors are most common. They do tend to recur, usually within 5 years. They require frequent follow-up and retreatment.

The study medication being used is administered one time intravesically (into the bladder) within 6 hours of the TURBT or Transurethral Resection of the Bladder Tumor.

OBJECTIVE:

To evaluate the recurrence rate of low grade bladder tumors in subjects who received the study medication versus those who had received placebo.

TRIAL QUALIFICATIONS:

  • 18 years of age and older
  • Male or Female
  • Must have transitional cell carcinoma of the bladder (low grade)
  • Must have less than 4 tumors identified at Cystoscopy and TURBT
  • Must be able to attend Cystoscopy Visit every 3 months
  • Must not have a red food dye allergy
  • Must not have a history of Interstitial Cystitis

Duration of Trial: 2 years

Most study related care provided at no cost. Compensation is available.

For further details and to determine eligibility, please contact 716-631-9654.


CURRENT TRIALS - Enrollment period complete.

Hypogonadism - Injectable study drug administered every 10-12 weeks.

Overactive Bladder for Men with BPH/Enlarged prostate - Urinary anti-spasmatic taken daily with BPH medication.


UPCOMING TRIALS

BENIGN PROSTATIC HYPERPLASIA or BPH, enlarged prostate, can cause men to experience urinary frequency, urgency, hesitancy, a feeling of not emptying, weak stream, and or urinary dribbling or leakage also called incontinence.

YOU DO NOT HAVE TO ‘JUST LIVE WITH IT’!

This trial will provide a PDE 5 inhibitor or placebo to be taken daily for 12 weeks.

If you are a male 45 years or older and are interested in a new form of BPH drug therapy, this trial will begin in mid-late January 2009!

TRIAL QUALIFICATIONS:

You will need to stop your current BPH, Overactive Bladder (OAB), and Erectile Dysfunction (ED) drug/therapy treatments for the duration of the trial, *once you have signed an informed consent.

  • You cannot have or had prostate cancer.
  • No previous history of prostate surgery.
  • No history of pelvic or bowel resection surgery.
  • No nitrate use ( ie. nitroglycerin sublingual).
  • You must be able to attend 7 clinic visits over 20 weeks.

All study related care is provided at no cost. Compensation is available.

For further details and to determine eligibility, please do not hesitate to contact 716-631-9654.


BENIGN PROSTATIC HYPERPLASIA or BPH, enlarged prostate *Specific for men who experience NOCTURIA (or nighttime urination).

Are you tired when you wake up?
Are your eyes heavy during the day?
Perhaps, your frequent nighttime trips to the bathroom are getting in the way of not doing what you really would like to do.

OBJECTIVE:

To evaluate the efficacy and safety of a drug to be used for men with BPH or enlarged prostate who experience nighttime voiding.

TRIAL QUALIFICATIONS:

  • Men 50 years of age and older
  • Must be able to complete a bladder diary and questionnaires
  • No history of  prostate cancer.
  • No history of prostate surgery.
  • No history of untreated sleep apnea.
  • Must be willing to stop current BPH drug treatments/therapies *once you have signed the informed consent.
  • No excessive caffeine consumption.
  • Duration of trial: 16 weeks approximately

All study related care is provided at no cost. Compensation is available.

THIS TRIAL IS EXPECTED TO BEGIN RECRUITMENT IN MID-LATE JANUARY 2009!

For further details and to determine eligibility, please contact 716-631-9654.