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Development of Novel Cystometrics for Overactive Bladder

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ClinicalTrials.gov Identifier: NCT02060214
Recruitment Status : Recruiting
First Posted : February 11, 2014
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date February 7, 2014
First Posted Date February 11, 2014
Last Update Posted Date July 15, 2019
Study Start Date January 2014
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 7, 2014)
Overactive Bladder/Urgency [ Time Frame: one year ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02060214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of Novel Cystometrics for Overactive Bladder
Official Title Development of Novel Cystometrics for Overactive Bladder
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.

Detailed Description

Aim 1. Validate an Urgency Meter and quantify urgency-volume relationship. Test the hypothesis that the tension sensor output of urinary urgency can be objectively measured and is reflected by the input of filling volume.

Aim 2. Quantify the bladder geometry-urgency relationship. Test the hypothesis that bladder geometry (wall thickness, surface area, and shape) affects the load on the detrusor tension sensor as reflected by objective changes in the output of urgency.

Aim 3. Quantify the dynamic compliance-urgency relationship. Test the hypothesis that dynamic compliance (strain-history and activation-history dependent compliance) affects the load on the detrusor tension sensor as reflected by objective changes in the output of urgency.

Aim 4. Quantify the spontaneous rhythmic contraction-urgency relationship. Test the hypothesis that spontaneous rhythmic contractions affect the load on the detrusor tension sensor as reflected by objective changes in the output of urgency.

Urinary urgency is the key symptom in Overactive Bladder (OAB) that occurs during the filling phase of micturition, and increased detrusor wall tension is thought to be a critical factor in the pathophysiology of OAB. However, because pressure increases little during bladder filling and does not reflect changes in detrusor wall tension, true filling phase physiology cannot be evaluated during clinical cystometrics. Thus, objective assessments of OAB using standard clinical cystometric testing is difficult or impossible. Furthermore, evaluation of OAB using verbal sensory thresholds recommended by the International Continence Society are subjective and poorly defined. Thus, there is a pressing need for a mechanistically relevant diagnostic test of OAB that incorporates objective metrics for the direct evaluation of detrusor wall tension.

Using a systems model of the filling phase of micturition, the detrusor smooth muscle and its in-series tension sensitive afferent nerves can be represented as a tension sensor with a definable input (volume), an objectively measurable output (urgency), and objectively measurable biomechanical parameters that affect the load on the tension sensor. Based on our previous investigations and the work of others, we have identified the following biomechanical parameters that can directly affect the load on the detrusor tension sensor during filling: bladder geometry, dynamic compliance, and spontaneous rhythmic contractions. In the current proposal, we will develop novel cystometric tests to assess bladder geometry, dynamic compliance, and spontaneous rhythmic contractions during the filling phase of micturition. Our new cystometrics will include 1) a sliding scale Urgency Meter that will allow patients to continuously record the tension sensor output of urgency, 2) two and three dimensional bladder ultrasonography to provide real-time measurements of bladder geometry that will be used to measure the effect of geometry and used for dynamic compliance calculations, and 3) Fast Fourier Transform (FFT) analysis to objectively measure filling phase spontaneous rhythmic contractions

These new metrics will provide a quantitative mechanistic link between OAB symptomatology and detrusor function, and we will use these new metrics to identify tension-mediated and non-tension mediated sub-groups of OAB. In this proposal, our central hypothesis, that measurable biomechanical parameters can directly affect the output (urgency) of the detrusor tension sensor, will be tested in clinical experiments involving accelerated hydration, abbreviated cystometrics, and repeat-fill cystometrics, and extended-hold cystometrics. Successful completion of this multi-PI proposal involving the combined skill sets of a neuro-urologist and a mechanical engineer will allow for 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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community Sample and Urology Clinic Patients
Condition Urinary Frequency/Urgency
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 7, 2014)
104
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Study 1:

  • Inclusion for Control Subjects:
  • 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

Inclusion for Heightened Urgency Group:

  • 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.
  • No vulnerable population

Exclusion Criteria:

Study 1:

Exclusion for Control Participants:

  • Prescription medications.
  • Significant medical conditions.
  • 21 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.

Exclusion for Heightened Urgency Group:

  • Significant medical conditions.
  • 21 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.
  • 21 years of age or younger.
  • Have cognitive impairment.
  • Vulnerable population
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Adam P Klausner (804) 828-5318 adam.klausner@vcuhealth.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02060214
Other Study ID Numbers HM20000453
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor Virginia Commonwealth University
Collaborators Not Provided
Investigators
Principal Investigator: Adam P Klausner, MD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date July 2019