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CompletedNCT04336280Updated Apr 7, 2020

Detrusor Underactivity: Presentation and Urodynamic Characteristics

An observational study in Detrusor Underactivity, sponsored by Mutah University. Completed at 1 site in Jordan. Open to participants aged 18 Years to 87 Years. Per ClinicalTrials.gov, last updated 2020-04-07.

Sponsored by Mutah University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
206
Ages
18 Years to 87 Years
Sex
All
01

Study 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.

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Conditions studied

  • Detrusor Underactivity
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In context

Urinary Bladder, Underactive

31 studies on the registry are indexed under Urinary Bladder, Underactive; 6 are open to participants now.

Browse Urinary Bladder, Underactive studies →

Lead sponsor

Mutah University is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 87 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients underwent UDS from July 2016 to August 2019

Exclusion criteria

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).
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
206 participants (actual)
Patient registry
No

Interventions

  • OtherSymptom 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 testUrodynamics

    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.

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What researchers measure

Primary outcomes

  1. Prevalence of detrusor underactivity in Jordan

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

    Time frame: 3 years

  2. 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.

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

  3. 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.

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

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Study locations

1 site
  • Istishari Urology Center (IUC)
    Amman, 11181, Jordan
08

References and documents

Individual participant data

Plan to share: Undecided — The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Feb 2020, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2020
First posted
Apr 7, 2020
StartActual
Jan 20, 2020
Primary completionActual
Feb 28, 2020
CompletionActual
Mar 25, 2020
Last update
Apr 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04336280
Lead sponsor
Mutah University
Collaborators
Istishari Urology Center
Responsible party
Fadi Sawaqed (Assistant Professor, Mutah University) — Principal investigator
First posted
Apr 7, 2020
Start date
Jan 20, 2020
Primary completion
Feb 28, 2020
Completion
Mar 25, 2020
Last update
Apr 7, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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