Overactive Bladder SyndromeNCT03486639
Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity
An observational study of Overactive Bladder Syndrome and Bladder Outlet Obstruction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome, Bladder Outlet Obstruction, Benign Prostate Enlargement
- What is being tested?
- IPSS questionnaire
- How many people
- 330 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2017to 19 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients reffered to Asaf HaRofeh Medical Center for Urodynamic examination
Who may be able to join
- All patients refered to Asaf HaRofeh Medical Center for Urodynamic examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofe Medical Center
Be’er Ya‘aqov, 73000
Guy Verhovsky, M.D, 089779409, guy.verchovsky@gmail.com
Kobi Stav, M.D, 089779409, stavkobi@gmail.com
About this study
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.
Read the 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).
- Conditions
- Overactive Bladder Syndrome, Bladder Outlet Obstruction, Benign Prostate Enlargement, Stress Incontinence (Female) (Male), Bladder Disease
- Being tested
- IPSS questionnaire
- Keywords
- Urodynamics, Bladder sensation, confounding factors
- Medical subject headings
- Urinary Bladder Neck Obstruction, Prostatic Hyperplasia, Urinary Incontinence, Stress, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPSS questionnaireOther
Also called International Prostate Symptoms Score
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing urodynamic | All patients older than 18 who are refered for Urodynamics examination Receives: Other: IPSS questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the urodynamic examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Jul 2017
- Primary completion1 Apr 2020
- Study completion19 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Kobi Stav, Assaf-Harofeh Medical Center
- Investigators
- Kobi Stav, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486639
- Sponsor's protocol ID
- 0101-17-ASF
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2018
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans of sharing participants data
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.
PubMed 19013605Schurch 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.
PubMed 12589626El-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.
PubMed 27535043
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity
- ClinicalTrials.gov ID
- NCT03486639
- Acronym / sponsor ID
- 0101-17-ASF
- Conditions
- Overactive Bladder Syndrome, Bladder Outlet Obstruction, Benign Prostate Enlargement, Stress Incontinence (Female) (Male), Bladder Disease
- Keywords
- Urodynamics, Bladder sensation, confounding factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 19 Aug 2020 (estimated)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing urodynamic | – | Other: IPSS questionnaireAll patients older than 18 who are refered for Urodynamics examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients reffered to Asaf HaRofeh Medical Center for Urodynamic examination
Key inclusion criteria (1 listed)
- All patients refered to Asaf HaRofeh Medical Center for Urodynamic examination
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPSS questionnaireAlso: International Prostate Symptoms ScoreIPSS 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 | Patients undergoing urodynamic |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- BackgroundCampbell Walsh Urology chapter 73
- Background: PubMed 19013605Lee 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.
- Background: PubMed 12589626Schurch 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.
- Background: PubMed 27535043El-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.
- Individual participant dataSharing planned: No. No plans of sharing participants data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kobi Stav, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome and Bladder Outlet Obstruction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Verhovsky, MD (972-8-9779409, guy.verchovsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early sensation during the filling phase (time frame: During the urodynamic examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03486639, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.