Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Early sensation during the filling phase
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Early sensation during the filling phase
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Kobi Stav
Head of the Neuro-Urologic Unit
Assaf-Harofeh Medical Center