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

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03486639
Collaborator
(none)
330
1
37.6
8.8

Study Details

Study Description

Brief 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.

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
330 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Aug 19, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing urodynamic

All patients older than 18 who are refered for Urodynamics examination

Other: IPSS 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.
Other Names:
  • International Prostate Symptoms Score
  • Outcome Measures

    Primary Outcome Measures

    1. Early sensation during the filling phase [During the urodynamic examination]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients refered to Asaf HaRofeh Medical Center for Urodynamic examination
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assaf Harofe Medical Center Be'er Ya'aqov Israel 73000

    Sponsors and Collaborators

    • Assaf-Harofeh Medical Center

    Investigators

    • Principal Investigator: Kobi Stav, MD, Assaf-Harofeh Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Prof. Kobi Stav, Head of the Neuro-Urologic Unit, Assaf-Harofeh Medical Center
    ClinicalTrials.gov Identifier:
    NCT03486639
    Other Study ID Numbers:
    • 0101-17-ASF
    First Posted:
    Apr 3, 2018
    Last Update Posted:
    Apr 21, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Prof. Kobi Stav, Head of the Neuro-Urologic Unit, Assaf-Harofeh Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 21, 2020