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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

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.


Condition or disease
Urinary Frequency/Urgency

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.


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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Development of Novel Cystometrics for Overactive Bladder
Study Start Date : January 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community Sample and Urology Clinic Patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060214


Contacts
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Contact: Adam P Klausner (804) 828-5318 adam.klausner@vcuhealth.org

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: Adam P Klausner, MD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Adam P Klausner, MD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02060214     History of Changes
Other Study ID Numbers: HM20000453
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms