Detrusor Underactivity: Presentation and Urodynamic Characteristics

Sponsor
Mutah University (Other)
Overall Status
Completed
CT.gov ID
NCT04336280
Collaborator
Istishari Urology Center (Other)
206
1
2.1
96.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Symptom questionnaire
  • Diagnostic Test: Urodynamics

Study Design

Study Type:
Observational
Actual Enrollment :
206 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
The Prevalence and Clinical Presentation of Detrusor Underactivity and Its Urodynamic Characteristics
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Feb 28, 2020
Actual Study Completion Date :
Mar 25, 2020

Outcome Measures

Primary Outcome Measures

  1. Prevalence of detrusor underactivity in Jordan [3 years]

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

  2. Symptomatic presentation of Detrusor underactivity [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 87 Years
Sexes Eligible for Study:
All
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istishari Urology Center (IUC) Amman Jordan 11181

Sponsors and Collaborators

  • Mutah University
  • Istishari Urology Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fadi Sawaqed, Assistant Professor, Mutah University
ClinicalTrials.gov Identifier:
NCT04336280
Other Study ID Numbers:
  • IUC - Detrusor Underactiivity
First Posted:
Apr 7, 2020
Last Update Posted:
Apr 7, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2020