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

NCT03486639 | Unknown

• 1 other identifier: 0101-17-ASF
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Urodynamics; Bladder sensation; confounding factors

Outcome Measures

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.

  During the urodynamic examination

Study Arms (1)

Patients undergoing urodynamic

All patients older than 18 who are refered for Urodynamics examination

Other: IPSS questionnaire

Interventions

IPSS questionnaire 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.

Also known as: International Prostate Symptoms Score

Patients undergoing urodynamic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients reffered to Asaf HaRofeh Medical Center for Urodynamic examination

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofe Medical Center

Be’er Ya‘aqov, 73000, Israel

RECRUITING

Related Publications (4)

• Campbell Walsh Urology chapter 73

  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.

  PMID: 19013605 BACKGROUND

• 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.

  PMID: 12589626 BACKGROUND

• 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.

  PMID: 27535043 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction; Prostatic Hyperplasia; Urinary Incontinence, Stress; Urinary Bladder Diseases

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urinary Incontinence; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kobi Stav, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Verhovsky, MD

CONTACT

972-8-9779409; guy.verchovsky@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Neuro-Urologic Unit

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: April 3, 2018
• Study Start: July 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: August 19, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)