We are no longer recruiting volunteers for this particular study. Please call our office at (860) 443-4567, for information about similar upcoming clinical research studies
 

Clinical Trial for Women of Various Demographic Characteristics

With Stress Urinary Incontinence

 The following is an overview of this clinical research trial and is intended to provide prospective patients with information that may help them decide whether to consider participating in the trial.  Please note that there are additional details regarding participating that are not listed on this page.  These will be discussed in person by a member of Coastal Connecticut Research, and all relevant information will be provided in the Informed Consent Form that must be read by the prospective participant.

Summary

Stress urinary incontinence (SUI) is the involuntary loss of urine due to physical activity.  Examples of physical activity that may trigger SUI episodes are sneezing, coughing, lifting and/or exercising. If urine loss is accompanied by a strong sudden urge prior to the leakage it is defined as urge incontinence.  Women who have had children may experience both stress and urge incontinence.

Incontinence episode frequency (IEF), a measure of SUI, is defined as the number of incontinence episodes experienced during a given span of time.  This trial requires an IEF count of 1 or more episodes a week.

Study Medication

This investigational study is designed to evaluate the safety and effectiveness of an investigational medication in women of different demographic characteristics with stress urinary incontinence.

This study is “open label” which means that all participants receive the study medication. Upon completion of this portion of the study, participants have the option of continuing in the open label extension during which they will receive the active study medication at no cost.

Basic Eligibility Requirements

Women of various demographic characteristics are encouraged to participate.

Ø       Minimum age 18

Ø       Experiencing loss of urine with physical activity (e.g. sneezing, exercising)

Ø       Must have symptoms typical of stress urinary incontinence for at least 3 months prior to study startup

Ø       Must be experiencing at least 1 episodes per week

Ø       May have symptoms of urge incontinence, or mixed urinary incontinence with predominant stress incontinence but must have

o        Twice as many SUI episodes as urge incontinence episodes

Ø       Be of non-childbearing potential or using medically accepted contraception

Ø       Free of urinary track infection (UTI) symptoms

Additional inclusion and exclusion criteria apply and will be reviewed with you.

Testing provided at no charge:

The initial part of the study will last approximately 10 weeks and will include 5 office visits (includes screening visit). Qualified participants will receive study-related exams and study medication.

Study related physical exams, lab work, EKGs and pregnancy tests will be performed free of charge. During the course of the study, participants will be asked to record number of incontinence episodes in a diary and fill out questionnaires assessing quality of life and improvements.

Duration of study:

Ø       10 weeks

Ø       After eligibility is determined, there is a baseline visit at which time medication is dispensed.

Ø       4 Follow-up visits with an option to continue in the open label extension study

Compensation

Eligible participants who are enrolled in the trial will receive up to $25 compensation for time and travel for each visit after enrollment.

Investigators

Robert Spitz, M.D.

Please note:

The preceding is an overview of this clinical trial and is intended to provide prospective patients with information that may help them decide whether to consider participating in the trial. There are additional details regarding study eligibility criteria, and details important to making a final decision regarding participating that are not listed on this page. These will be discussed with interested participants over the phone and in person by a member of Coastal Connecticut Research. All relevant information will be provided in the Informed Consent Form that must be reviewed by the prospective participant.

At Coastal Connecticut Research, we are excited to introduce this investigational medication to you, and hope that you will consider joining us in this trial.

If you would like more information, or to see if you qualify for this study, please contact study coordinators:

Carolyn Eustace, RA
Karen Cuddy, RN

1-860-443-4567

or contact us by e-mail at CCRvolunteer@gmail.com