Detrusor Underactivity: Presentation and Urodynamic Characteristics

Detrusor Underactivity Clinical Trial

Official title:

The Prevalence and Clinical Presentation of Detrusor Underactivity and Its Urodynamic Characteristics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336280
• Other study ID #: IUC - Detrusor Underactiivity
• Status: Completed
• Start date: January 20, 2020
• Est. completion date: March 25, 2020

Study information

• Verified date: April 2020
• Source: Mutah University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: March 25, 2020
• Est. primary completion date: February 28, 2020
• Gender: All
• Age group: 18 Years to 87 Years

Eligibility

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).

Related Conditions & MeSH terms

• Detrusor Underactivity
• Hypokinesia
• Urinary Bladder, Underactive

Intervention

Other:
• Symptom questionnaire
Arabic version of the International Prostate Symptom Score: Known and validated questionnaire to quantify and qualify the severity of symptoms of the lower urinary tract

Diagnostic Test:
• Urodynamics
Urodynamics: 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.

Locations

Country	Name	City	State
Jordan	Istishari Urology Center (IUC)	Amman

Sponsors (2)

Lead Sponsor	Collaborator
Mutah University	Istishari Urology Center

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of detrusor underactivity in Jordan	The proportion of patients with lower urinary tract symptoms found to be affected by Detrusor underactivity	3 years
Primary	Symptomatic presentation of Detrusor underactivity	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.	over one month period prior to clinical evaluation during the 3 years time period
Primary	Urodynamics parameters	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.	Each test takes around 30-45 minutes, all urodymanics studies were performed during the study period