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Post Void Dribbling Clinical Trial Overview

Overview

 
The UW Health Post Void Dribbling clinical trial is designed to determine the effectiveness of Solifenacin (brand name for Vesicare©) in treating post void dribbling symptoms. Women who complain of post void dribbling have leakage of urine after they have completed voiding and are rising from the toilet. Often leakage will be noted on the toilet seat or in the underpants. This is a randomized controlled trial, meaning that you may receive medication or a placebo. The trial will include 140 subjects at three clinical sites. At the University of Wisconsin, subjects will be seen at the Clinical Trial Research Center. Eligible patients must have symptoms of post void dribbling at least two times per week. There are a total of four study visits, one screening visit and one post-treatment follow-up phone call.
 
Selecting Participants
 

To be included in this study you must:

  • Be a woman between the ages of 18 and 89
  • Have incontinence in the form of post void dribbling that occurs at least twice weekly.

You will be excluded if you:

  • Have severe renal or hepatic disease
  • Have active urinary tract infection
  • Have glaucoma
  • Have stress incontinence as the only incontinence symptom
  • Have urge incontinence as the only incontinence symptom
  • Have chronic severe constipation
  • Have a history of bladder cancer
  • Have a known or suspected hypersensitivity to anticholinergics
  • Have any clinical condition that would not allow safe completion of the study
  • Are pregnant or lactating, intend to become pregnant during the study, or if you use an unreliable birth control method and are a woman of childbearing potential. Reliable forms of contraception include: permanent sterilization of either partner, hormonal contraception (oral contraceptive, Nuva ring, contraceptive patch, depoprovera or implants), IUD - intrauterine device - and condoms. Abstinence is considered a reliable form of contraception, but abstinent subjects will be informed that they need to use condoms or another form of birth control mentioned above if they are sexually active during the study.
  • Are presently on systemic anti-cholinergic therapy or have been on therapy within the past four weeks. Anti-cholinergic drugs include darifenacin (Enablex), fesoterodine (Toviaz), hyoscyamine, oxybutynin (Ditropan), solifenacin (Vesicare), tolterodine (Detrol) and trospium (Sanctura).
  • Take solid forms of potassium supplementation, as this presents an increased risk of gastrointestinal side effects.

What Happens in the Study

  • Screening visit (1): All subjects will have a screening visit, where inclusion and exclusion criteria will be reviewed. Medical records will be reviewed if necessary. Patients will provide a urine sample to check for pregnancy and evidence of urinary tract infection. We expect this visit to take from 30 to 60 minutes.
  • Study visits (4): Subjects will receive 12 weeks of Solifenacin (Vesicare) 5mg, which is FDA approved for the treatment of urinary frequency, night time voiding and urge incontinence. It is well tolerated in the general population and has been clinically available in the United States since 2005. While on medication, we will monitor the severity of post void dribbling symptoms. Subjects will complete simple voiding diaries. (Diary example pdf) No measurements are necessary. The drug will be dispensed at the monthly follow-up visits. During the visits, subjects also will fill out questionnaires (5 minutes) and drop off completed voiding diaries. Follow-up visits are expected to take 10 to 15 minutes. There will be no exams or invasive testing.
  • Subjects will be contacted by phone one month after completing the drug.

Costs/Compensation

  • The drug is free and there is no cost to participate
  • Subjects will receive compensation for participating in the study. They will receive $25 at the third visit and $75 at the fifth visit.

Online Resources

 

Additional Questions

 

Contact our nurse coordinator at (608) 890-6462.