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

NCT ID: NCT03486639

Last Updated: 2020-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-08-19

Brief Summary

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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

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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).

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing urodynamic

All patients older than 18 who are refered for Urodynamics examination

IPSS questionnaire

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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International Prostate Symptoms Score

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Kobi Stav

Head of the Neuro-Urologic Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kobi Stav, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Locations

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Assaf Harofe Medical Center

Be’er Ya‘aqov, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Guy Verhovsky, MD

Role: CONTACT

972-8-9779409

Facility Contacts

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Guy Verhovsky, M.D

Role: primary

089779409

Kobi Stav, M.D

Role: backup

089779409

References

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Campbell Walsh Urology chapter 73

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19013605 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12589626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27535043 (View on PubMed)

Other Identifiers

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0101-17-ASF

Identifier Type: -

Identifier Source: org_study_id

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