Comparative Urine Proteomic Studies of Overactive Bladder in Humans

NCT01367886 | Completed Results DMC

• 1 other identifier: WS473527
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder

Keywords

Urine proteomics; overactive bladder

Outcome Measures

Primary Outcomes (2)

• Bladder Diary to Assess Urinary Frequency at Baseline and at End of 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.

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

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

  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.

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (1)

Fesoterodine

OTHER

Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.

Drug: fesoterodine

Interventions

fesoterodine DRUG

Fesoterodine 4 mg. tablet by mouth daily for six weeks

Also known as: Toviaz

Fesoterodine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females ≥ 18 years old
• Not experiencing overactive bladder symptoms
• Not experiencing frequency or urgency
• Females ≥ 18 years old
• Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) \> 3/year

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

No serious adverse events.

Results Point of Contact

• Title: H. Henry Lai, MD
• Organization: Washington University School of Medicine

laih@wudosis.wustl.edu

314-362-8295

Study Officials

• H. Henry Lai, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: June 7, 2011
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 27, 2015
• Results First Posted: January 12, 2015

Record last verified: 2015-02

Locations

US (1)