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Completed

NCT Number: NCT01367886

Comparative Urine Proteomic Studies of Overactive Bladder in Humans

This study is being done to evaluate the use of a new technology (urine proteomics) - the study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a simple voided urine specimen.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

The objectives of the study are:

  • to improve the diagnosis of overactive bladder using a non-invasive technology (urine proteomics) and
  • to study how potential urine biomarkers changes with overactive bladder symptoms after patients have been treated with fesoterodine, an FDA approved drug for the treatment of overactive bladder.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For healthy volunteers the inclusion criteria are:

  • Females ≥ 18 years old
  • Not experiencing overactive bladder symptoms
  • Not experiencing frequency or urgency

For overactive bladder patients the inclusion criteria are

  • Females ≥ 18 years old
  • Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) > 3/year

Exclusion criteria

For healthy volunteers the exclusion criteria are:

  • Overactive bladder symptoms, such as frequency and urgency
  • Intermittent/unstable use of bladder medications
  • Pregnant women or women unwilling to use contraceptives
  • Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury
  • Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
  • Lower urinary tract surgery within past 6 months
  • Known history of IC or pain associated with OAB
  • Urinary retention requiring catheterization, indwelling catheter of Self-cath
  • Recurrent UTIS > 3/year

For overactive bladder patients the exclusion criteria are:

  • Contraindications to Fesoterodine use such as hypersensitivity, GI and urinary retention, and Glaucoma
  • Intermittent/unstable use of bladder medications
  • Pregnant women or women unwilling to use contraceptives
  • Neurological conditions: stroke, MS, Parkinson's, spinal cord injury
  • Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
  • Lower urinary tract surgery within past 6 months
  • Known history of Interstitial Cystitis (IC) or pain associated with OAB
  • Urinary retention requiring catheterization, indwelling catheter of Self-cath
  • Recurrent urinary tract infections (UTIS) > 3/year

Deferral Criteria:

Treatment with OAB medications within 2 weeks before baseline visit. If patient is currently on OAB medications the patient will be asked to stop OAB medication for 2 weeks and return for baseline visit.

Treatment and study plan

Fesoterodine

Drug

Fesoterodine 4 mg. tablet by mouth daily for six weeks

Other names: Toviaz

Primary outcomes

  1. Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment

    Time frame: Outcome measure was assessed at baseline and at the end of the 6-week treatment

    Overactive bladder subjects filled out a 3-day bladder diary before starting Fesoterodine and another 3-day bladder diary at the end of taking 6 weeks of Fesoterodine. The bladder diary was used to assess urinary frequency. The average number of urinations (frequency) per day over a period of 3 days before the start of medication and at the end of 6 weeks of medication were compared for each subject and then as a group.

  2. Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment

    Time frame: Outcome measure was assesses at baseline and at the end of the 6-week treatment period.

    The Urinary Sensation Scale found in the bladder diary given to subjects was used to assess urinary urgency. The Urinary Sensation Scale was filled out by the subject for 3 days before starting Fesoterodine and filled out again for 3 days at the end of taking 6 weeks of Fesoterodine. The scale ranges from 1 (no feeling of urgency), 2 (mild), 3 (moderate), 4 (severe) to 5 (unable to hold; leak urine). The urgency scale with the most check marks per day over a period of 3 days before start of medication was averaged for each subject. The urgency scale with the most check marks per day over a period of 3 days at the end of taking 6 weeks of medication was averaged for each subject. Then, the average before start of medication for all subjects and the average at the end of taking 6 weeks of medication for all subjects were compared.

Secondary outcomes

  1. Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.

    Time frame: Outcome measure was assessed at baseline and after the 6 week visit.

    Overactive Bladder subjects answered the Overactive Bladder Questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions # 1 (Frequent urination during the daytime hours?); #5 (Nighttime urination?) and #6 (Waking up at night because you have to urinate?) are asking about frequency. Choices of answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal) 6 (A very great deal). Multiple responses to the questionnaire were averaged for each participant at baseline and at 6 weeks and then all participants' answers were totaled and averaged at baseline and at 6 weeks.

  2. Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..

    Time frame: Outcome measures were assessed at baseline and after the 6 week visit.

    Overactive bladder subjects answered the Overactive Bladder questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions #2 (An uncomfortable urge to urinate?); #3 (A sudden urge to urinate with little or no warning?); #4 (Accidental loss of small amounts of urine?); #7 (An uncontrollable urge to urinate?); #8 (Urine loss associated with a strong desire to urinate?) are asking about urgency. Choices for answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal); 6 (A very great deal). Multiple responses to the questionnaire was averaged per participant at baseline and at 6 weeks and then all participants answers were totaled and then averaged at baseline and at 6 weeks.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2011
Registry last updated
Feb 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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