- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04336280
Detrusor Underactivity: Presentation and Urodynamic Characteristics
April 2, 2020 updated by: Fadi Sawaqed, Mutah University
The Prevalence and Clinical Presentation of Detrusor Underactivity and Its Urodynamic Characteristics
Detrusor underactivity (DU) is a known disease of the muscles of the urinary bladder that defined as a weak contraction of the muscle resulting in a failure to achieve complete bladder emptying.
Recently, DU as a cause of Lower Urinary Tract Symptoms in both men and women has been increasingly gaining attention.
There is a major issue in differentiation of underactive bladder symptoms and other causes of lower urinary tract symptoms such as detrusor hyperactivity and impaired contractility (DHIC), hypersensitive bladder (HSB), detrusor overactivity (DO), bladder outlet obstruction (BOO) and Dysfunctional Voiding (DV).
Urodynamics (UDS) is the standard diagnostic tool, it includes invasive recording of the pressure that is produced when the bladder muscle contracts via pressure sensors introduced in the urinary bladder through special types of urethral catheters.
This study aims to determine the prevalence of DU along with its symptomatic and urodynamics (UDS) characteristics of DU in Jordanian population through a retrospective chart review.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
206
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amman, Jordan, 11181
- Istishari Urology Center (IUC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 87 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study has reviewed a retrospective chart for 334 patients underwent UDS at the Istishari Urology Center (IUC), Amman, Jordan from July 2016 to August 2019.
The study has excluded 77 records of patients in the initial stage either due to missing data (4 cases) or exclusion criteria (73 cases), the final study population was considered to be 206 patients.
Description
Inclusion Criteria:
- Patients underwent UDS from July 2016 to August 2019
Exclusion Criteria:
- Patients with neurogenic bladder (NB) due to known underlying neurological disease, history of open pelvic surgery or major abdominal surgery, or using indwelling catheters or clean intermittent catheterization (CIC).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of detrusor underactivity in Jordan
Time Frame: 3 years
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The proportion of patients with lower urinary tract symptoms found to be affected by Detrusor underactivity
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3 years
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Symptomatic presentation of Detrusor underactivity
Time Frame: over one month period prior to clinical evaluation during the 3 years time period
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Arabic version of the International Prostate Symptom Score was used to assess the prevalence and severity of the symptoms that are associated with detrusor underactivity.
The questionnaire includes 8 questions, the 1st 7 questions are about the urinary symptoms (Incomplete emptying, urinary frequency, intermittency, urgency, weak urine stream, straining and nocturia) and the 8th is about Quality of Life due to Urinary Symptoms.
Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom.
The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
The answers to the 8th question (quality of life) range from "delighted" to "terrible" or 0 to 6.
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over one month period prior to clinical evaluation during the 3 years time period
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Urodynamics parameters
Time Frame: Each test takes around 30-45 minutes, all urodymanics studies were performed during the study period
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Urodynamics is a series of tests conducted in an outpatient setting that evaluates the function of the urinary bladder, including physiological parameters of how completely the bladder, sphincter and urethra are storing and releasing urine.
These parameters are recorded by pressure sensors that are inserted into the bladder via special urinary catheters to measure the pressure that is generated during storing and releasing urine.
The assessment of urodynamic variables is based on bladder capacity, presence of involuntary bladder muscle contractions, bladder volume at 1st sensation of bladder filling, bladder volumes at normal and strong desire for urination, detrusor pressure at maximum flow of urine during voiding, volume voided, and the post-void residual urine volume.
All urodynamic testing was performed based on the International Continence Society standards.
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Each test takes around 30-45 minutes, all urodymanics studies were performed during the study period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2020
Primary Completion (Actual)
February 28, 2020
Study Completion (Actual)
March 25, 2020
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 2, 2020
First Posted (Actual)
April 7, 2020
Study Record Updates
Last Update Posted (Actual)
April 7, 2020
Last Update Submitted That Met QC Criteria
April 2, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUC - Detrusor Underactiivity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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