DEPARTMENT OF UROLOGY - RESEARCH

Urinary Incontinence

BRinging simple urge Incontinence DiaGnosis & treatment to providers (Bridges) HSC 200900097H

Condition

Urge Incontinence

Status

Recruiting New Participants

Purpose

Learn if answers to a simple questionnaire can provide an accurate diagnosis of your problem with incontinence.

Determine if fesoterodine, an FDA approved medication for people with symptoms of urge urinary incontinence, urgency and urinary frequency that is available by prescription, .is more effective than placebo (a pill that looks like fesoterodine but contains no medicine) in reducing the number of accidental urine leaks.

Eligibility

Female, 18 years of age or older, willing to use contraception to prevent pregnancy (if capable of becoming pregnant) during study participation, experienced symptoms of urge incontinence for at least 3 months and able to remain on a stable medication regime for the duration of the study.

Study Design

This study is divided into 2 parts:

  • First there is a 12 week study in which all are randomized to receive either fesoterodine or placebo once a day for 12 weeks.
  • The Second part is a 9 month open label study in which all get fesoterodine, at no charge, once a day for 9 months.

Treatment

fesoterodine 4 mg or 8 mg

Follow Up

In the 12 week randomized trial there is a screening visit, baseline visit, 2 week, 4 week, 8 week and 12 week visits. For the 9 month open label study there are study visits at 14 weeks, 16 weeks, 6 months, 9 months and 12 months.

Sponsor

Conducted by the University of California, San Francisco (UCSF) and sponsored by Pfizer, Inc.

Contact information

Elvira Eardley, LVN III 210-567-0550
Abigail-Perez Contreras, 210-567-1130

Trial of Mid-Urethral Sling (TOMUS) HSC HSC2006176H

Condition

Stress Urinary Incontinence

Status

Ongoing; enrollment complete

Purpose

The study was designed to compare the outcomes of minimally invasive surgical procedures to treat stress urinary Incontinence in women. These surgical procedures are called mid-urethral slings. The procedures insert a mesh sling or "hammock" to support the bladder neck so that urine does not leak. Both procedures have been approved by the FDA and have been shown to be safe and successful in treating stress urinary incontinence. However, we do not know if one is better than the other. This study will answer that question.

Study Design

Is a randomized trial with two groups, one group receives the Trans-obturator sling procedure and the other group receives the tension free vaginal tape

Treatment

Surgery mid urethral sling procedure, TVT or TOT

Follow Up

6 month 12 month and 24 month

Sponsor

The National Institutes of Diabetes, and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), is a federal agency that promotes scientific research. NIDDK is funding this study (the sponsor).

Extended- Trial of Mid-Urethral Sling (E-TOMUS) HSC 20090313H

Condition

Stress Urinary Incontinence

Status

Ongoing; enrollment open only to TOMUS cohort

Purpose

Extended Trial Of Mid-Urethral Slings (E-TOMUS) is an observational study of women who have completed participation in the Trial Of Mid-Urethral Slings (TOMUS) study which is a randomized trial comparing retropubic and transobturator mid-urethral sling procedures in women undergoing surgery for stress urinary incontinence (SUI). Though the TOMUS study follows participants for 2-years after their surgery, many experts feel that 2-years are too short to evaluate long-term sequelae of the procedures. The primary aim of E-TOMUS is to extend the TOMUS follow-up in order to describe continence rates over 7-years following the index surgery and to compare the long-term outcomes of the retropubic and transobturator mid-urethral sling procedures for the treatment of SUI.

Study Design

E-TOMUS is an observational study that extends the follow-up of women enrolled in TOMUS to 7 years after the index surgery

Treatment

No treatment

Follow Up

Annually

Sponsor

The National Institutes of Diabetes, and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), is a federal agency that promotes scientific research. NIDDK is funding this study (the sponsor).

Value of Urodynamic Evaluation (ValUE) HSC 20080546H

Condition

Stress Incontinence (SUI)

Status

Recruiting New Participants

Purpose

Women who decide to have surgery to treat their SUI regularly have a bladder function test (UDS) before they have surgery. Though most doctors who regularly perform incontinence surgeries order these tests, they are expensive, time-consuming, and uncomfortable. We don’t know if women who receive these tests have better treatment results than women who don’t receive them. The researchers hope to learn if women desiring surgery for their SUI and receive a basic office evaluation only without Urodynamic studies (UDS) have different treatment results compared to women who receive the office evaluation and UDS before stress incontinence surgery.

Eligibility

Female person with SUI; at 21 years old or older, not pregnant and never intends to get pregnant; willing to consider surgical treatment for incontinence and be available for 12 months. In this study the treatment of incontinence is routine care. This means it is the same treatment whether one is in the study or not. The subject must have health care benefits to cover the routine care.

Study design

Randomized trial with two groups- one group that will have a UDS prior to treatment, the other group will have NO UDS prior to treatment.

Treatment

All subjects receive treatment of SUI. The SUI treatment is based on study doctor clinical judgment treatment, treatment is not dictated by the research study design.

Follow Up

While talking part in this study, the subject will be asked to attend approximately 3 visits with the researchers or study staff, one for screening and 2 after surgery.

Sponsor

The National Institutes of Diabetes, and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), is a federal agency that promotes scientific research. NIDDK is funding this study (the sponsor).

Contact information

Caren Prather, RN 210-567-0548

Combined Behavioral and Drug Treatment of Overactive Bladder in Men (COBALT) HSC 20100148H

Condition

Lower Urinary Tract Symptoms (LUTS) in men such as frequency of urination, urgency of urination, frequent nighttime urination

Status

Recruiting New Participants

Purpose

Test the effectiveness of combining behavioral treatment and drug therapy as a way to improve outcomes in the treatment of urinary tract symptoms in men.

Eligibility

Men 40 years old or over who are experiencing both frequency of urination and urgency to urinate

Study Design

2 phase, 3-arm randomized clinical trial. The first phase will be randomization to 6 weeks of behavioral therapy, drug therapy, or combined drug + behavioral therapy. The second phase is a crossover to six weeks of the other treatment.

Treatment

Behavioral treatment, Detrol LA and tamsulosin

Sponsor

National Institutes of Health: University of Alabama, Birmingham

Contact information

Caren Prather, RN 210-567-0548

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