NCT04336280

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 1, 2020

Last Update Submit

April 2, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Prevalence of detrusor underactivity in Jordan

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

    3 years

  • 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

  • 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

Interventions

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

UrodynamicsDIAGNOSTIC_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.

Eligibility Criteria

Age18 Years - 87 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients underwent UDS from July 2016 to August 2019

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istishari Urology Center (IUC)

Amman, 11181, Jordan

Location

MeSH Terms

Conditions

Urinary Bladder, Underactive

Interventions

Urodynamics

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 7, 2020

Study Start

January 20, 2020

Primary Completion

February 28, 2020

Study Completion

March 25, 2020

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations