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

Overactive Bladder Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03486639
• Other study ID #: 0101-17-ASF
• Status: Recruiting
• Start date: July 1, 2017
• Est. completion date: August 19, 2020

Study information

• Verified date: April 2020
• Source: Assaf-Harofeh Medical Center
• Contact: Guy Verhovsky, MD
• Phone: 972-8-9779409
• Email: guy.verchovsky[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: August 19, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Be'er Ya'aqov

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Campbell Walsh Urology chapter 73

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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