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

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.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder Syndrome; Bladder Outlet Obstruction; Benign Prostate Enlargement; Stress Incontinence (Female) (Male); Bladder Disease
• Intervention / Treatment: Other: IPSS questionnaire

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 Type: Observational
• Enrollment (Anticipated): 330

Contacts and Locations

• Study Contact: Name: Guy Verhovsky, MD; Phone Number: 972-8-9779409; Email: guy.verchovsky@gmail.com

Study Locations

• Israel
  • Be'er Ya'aqov, Israel, 73000
    • Recruiting
    • Assaf Harofe Medical Center
    • Contact: Guy Verhovsky, M.D; Phone Number: 089779409; Email: guy.verchovsky@gmail.com
    • Contact: Kobi Stav, M.D; Phone Number: 089779409; Email: stavkobi@gmail.com
    • Principal Investigator: Guy Verhovsky, MD
    • Sub-Investigator: Kobi Stav, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients reffered to Asaf HaRofeh Medical Center for Urodynamic examination

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): April 1, 2020
• Study Completion (Anticipated): August 19, 2020

Study Registration Dates

• First Submitted: March 24, 2018
• First Submitted That Met QC Criteria: April 1, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 19, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Urodynamics; Bladder sensation; confounding factors
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Urination Disorders; Urethral Diseases; Urinary Incontinence; Urethral Obstruction; Urinary Bladder, Overactive; Prostatic Hyperplasia; Urinary Incontinence, Stress; Urinary Bladder Diseases; Urinary Bladder Neck Obstruction
• Other Study ID Numbers: 0101-17-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plans of sharing participants data

Drug and device information, study documents

• 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