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Status unknownNCT03486639Updated Apr 21, 2020

Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity

An observational study in Overactive Bladder Syndrome, Bladder Outlet Obstruction and Benign Prostate Enlargement, sponsored by Assaf-Harofeh Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by Assaf-Harofeh Medical Center · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
330
Ages
18 Years and older
Sex
All
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Study summary

Urodynamic examination evaluates storage and empting phases of the urinary bladder. It enables the clinician to correlate physiologic findings to patients' complains. The data gathered during the examination divided to storage and empting.

During the storage phase, bladder sensation is measured while the bladder is filled with sterile water. During years of practice, we noticed that early sensation (bladder over-sensitivity) is occasionally associated with bladder outlet obstruction (as demonstrated in the emptying phase of the examination.

Read the detailed description

The study includes patients who were referred to Urodynamics examination due to lower urinary tract symptoms. There is no actual intervention during the examination. Though, patients are asked to fill an International prostate symptom score (IPSS-questionnaires).

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Conditions studied

  • Overactive Bladder Syndrome
  • Bladder Outlet Obstruction
  • Benign Prostate Enlargement
  • Stress Incontinence (Female) (Male)
  • Bladder Disease

Keywords

  • Urodynamics
  • Bladder sensation
  • confounding factors
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In context

Urinary Bladder Neck Obstruction

46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.

This study's planned enrollment of 330 is above the median of 165 across 14 observational studies indexed under Urinary Bladder Neck Obstruction.

Browse Urinary Bladder Neck Obstruction studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are 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 and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients reffered to Asaf HaRofeh Medical Center for Urodynamic examination

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

  • All patients refered to Asaf HaRofeh Medical Center for Urodynamic examination

Exclusion criteria

Exclusion Criteria:

  • Inability to sign an informed concent
  • Administration of analgesics 8 hours prior to the examination
  • Known urethral stricture
  • Chronic bladder or urethral pain
  • Active cystitis
  • Permanent urinary catheter
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
330 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients undergoing urodynamic

    All patients older than 18 who are refered for Urodynamics examination

    Other: IPSS questionnaire

Interventions

  • OtherIPSS questionnaire

    IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of patients with lower urinary tract symptoms. It was validated for both genders.

    Also known as: International Prostate Symptoms Score

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What researchers measure

Primary outcomes

  1. Early sensation during the filling phase

    Bladder oversensitivity (early sensation), a diagnosis made by symptoms and urodynamic investigations. Defined as an increased perceived bladder sensation during bladder filling with specific cystometric findings of: (i) an early first desire to void; (ii) an early strong desire to void, which occurs at low bladder volume; (iii) a low maximum cystometric bladder capacity; no abnormal increases in detrusor pressure.

    Time frame: During the urodynamic examination

07

Study locations

1 of 1 sites recruiting
  • Assaf Harofe Medical Center
    Be'er Ya'aqov, 73000, Israel
    Recruiting
08

References and documents

Publications

  • Campbell Walsh Urology chapter 73
  • Lee WC, Wu HP, Tai TY, Yu HJ, Chiang PH. Investigation of urodynamic characteristics and bladder sensory function in the early stages of diabetic bladder dysfunction in women with type 2 diabetes. J Urol. 2009 Jan;181(1):198-203. doi: 10.1016/j.juro.2008.09.021. Epub 2008 Nov 14. PubMed 19013605 ↗
  • Schurch B, Schmid DM, Kaegi K. Value of sensory examination in predicting bladder function in patients with T12-L1 fractures and spinal cord injury. Arch Phys Med Rehabil. 2003 Jan;84(1):83-9. doi: 10.1053/apmr.2003.50007. PubMed 12589626 ↗
  • El-Zawahry A, Alanee S, Malan-Elzawahry A. The Use of Urodynamics Assessment Before the Surgical Treatment of BPH. Curr Urol Rep. 2016 Oct;17(10):73. doi: 10.1007/s11934-016-0626-y. PubMed 27535043 ↗

Individual participant data

Plan to share: No — No plans of sharing participants data

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03486639
Responsible party
Prof. Kobi Stav (Head of the Neuro-Urologic Unit, Assaf-Harofeh Medical Center) — Principal investigator
First posted
Apr 3, 2018
Start date
Jul 1, 2017
Primary completion
Apr 1, 2020
Completion
Aug 19, 2020 (estimated)
Last update
Apr 21, 2020

Study contacts

Guy Verhovsky, MD
Contact
guy.verchovsky@gmail.com
972-8-9779409
Kobi Stav, MD
principal investigator · Assaf-Harofeh Medical Center

Oversight

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

Not currently enrolling

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

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