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NCT Number: NCT04336280

Detrusor Underactivity: Presentation and 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.

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Key information

Conditions

Detrusor Underactivity Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Underactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–87 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istishari Urology Center (IUC)

Amman, 11181, Jordan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Symptom questionnaire

Other

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

Urodynamics

Diagnostic Test

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.

Primary outcomes

  1. Prevalence of detrusor underactivity in Jordan

    Time frame: 3 years

    The proportion of patients with lower urinary tract symptoms found to be affected by Detrusor underactivity

  2. Symptomatic presentation of Detrusor underactivity

    Time frame: over one month period prior to clinical evaluation during the 3 years time period

    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.

  3. Urodynamics parameters

    Time frame: Each test takes around 30-45 minutes, all urodymanics studies were performed during the study period

    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.

Sponsors and collaborators

Lead sponsor

Mutah University

Other

Collaborators

  • Istishari Urology Center

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2020
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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