Development of Novel Cystometrics for Overactive Bladder

NCT02060214 | Withdrawn

• 1 other identifier: HM20000453
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary urgency is the key symptom of overactive bladder (OAB). A critical barrier in understanding OAB is the lack of a method to separate urgency that derives directly from bladder filling or what we term "tension sensor output" and urgency that derives from abnormal brain interpretation. The central hypothesis is that measureable biomechanical parameters can directly affect the output (urgency) of the detrusor tension sensor. The development of novel cystometric tests for the improved diagnosis and treatment of OAB and for the potential identification of novel mechanistic targets in the pathophysiology of OAB.

Conditions

Urinary Frequency/Urgency

Outcome Measures

Primary Outcomes (1)

• Overactive Bladder/Urgency

  validating the use of a computer program which will assist patients in describing their level of urgency. This and the use of ultrasound measurements of the bladder will assist us in developing a means to measure urgency for normal, healthy participants and those with elevated urgency.

  one year

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample and Urology Clinic Patients

You may qualify if:

• Study 1:
• No urgency defined as scoring a "0" on the screening question 5A of ICIQ-OAB survey instrument.
• Above 21 years of age.
• Healthy enough to undergo testing
• No Cognitive Impairment
• No vulnerable population
• Answer greater than or equal to 3 on question 5a of ICIQ-OAB survey instrument.
• Above 21 years of age.
• Healthy enough to undergo testing.
• Have no cognitive impairment.
• Not vulnerable population
• Study 2, 3 and 4:
• Scheduled to undergo cystoscopy examinations for clinically indicated condition.
• Over 21 years of age.
• No cognitive impairment.

You may not qualify if:

• Study 1:
• Prescription medications.
• Significant medical conditions.
• years of age or younger
• Cognitive impairment.
• Vulnerable population.
• Scoring anything other than "0" on all screening questions on the ICIQ-OAB.
• Score less than or equal to 3 on question 5a of ICIQ--OAB.
• Significant medical conditions.
• years of age or younger.
• Cognitive impairment.
• Vulnerable population.
• Score less than 3 on question 5a of ICIQ-OAB.
• Study 2, 3, and 4:
• Not undergoing standard of care cystoscopy examinations for clinically indicated conditions.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

• Adam P Klausner, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: January 20, 2014
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

US (1)