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

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

• Registration Number: NCT03486639
• Lead Sponsor: Assaf-Harofeh Medical Center

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 Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-03-24
• Study First Submitted QC: 2018-04-01
• Study First Posted: 2018-04-03
• Status Verified: 2020-04
• Primary Completion: 2020-04-01
• Last Update Submitted: 2020-04-19
• Last Update Posted: 2020-04-21
• Study Completion: 2020-08-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Be'er Ya'aqov, Israel