UrodynamicsNCT05666063
Comparison of Single Voiding Cycle and Two and Three Voiding Cycles in Ambulatory Urodynamic Studies
An observational study of Urodynamics and Urinary Incontinence, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Urodynamic studies are objective diagnostic methods recommended and used in the evaluation and diagnosis of urinary incontinence, which is a very common problem that can significantly affect women's health and quality of life, cause social and economic losses. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urodynamics, Urinary Incontinence, Urogenital Disease, Female
- What is being tested?
- Ambulatory Urodynamic Study
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2023to Aug 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who applied to Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology with complicated urinary system symptoms detected by anamnesis and physical examination will be included.
Who may be able to join
- Age > 18 years
- No suspicion of pregnancy
- Adequate mental functions
- Cases of stress urinary incontinence not confirmed by cough testing
- Having inconsistent examination results
- Significant urge, urge incontinence and/or overactive bladder complaints
Show all 9Show fewer
- Cases with mixed-type urinary incontinence with a predominant complaint of urgency
- Those with a history of pelvic organ prolapse repair surgery
- Those with a history of anti-incontinence surgery
Who cannot join
- Presence of active urinary tract infection
- Patients to be treated conservatively
- Presence of urinary retention
Trial locations and contacts
1 site in 1 country.
Esra Cetinkaya, M.D. contact
About this study
Urodynamic studies are objective diagnostic methods recommended and used in the evaluation and diagnosis of urinary incontinence, which is a very common problem that can significantly affect women's health and quality of life, cause social and economic losses. With these examinations, objective observation of bladder functions, repetition and classification of patients' symptoms, and identification of the underlying pathological cause, if possible, are provided in the evaluation of lower urinary system dysfunctions; In this way, the diagnosis is made, the choice of treatment is affected, the results of the treatment can be predicted and appropriate counseling can be given to the patients. Although conventional urodynamics is currently accepted as the gold standard test in the investigation of lower urinary tract symptoms, non-physiological retrograde bladder filling may adversely affect the test results and patients have to be under observation on the examination table while being examined with the conventional urodynamic method. Conventional method may not be effective enough in revealing the etiopathogenesis of lower urinary system symptoms, because they cannot perform activities where lower urinary system symptoms occur. Although many studies have shown that the diagnostic value of ambulatory urodynamics (AU) is higher in urogynecology clinical practice, it was not found suitable for routine investigation due to its longer duration, time-consuming and cost-effectiveness. For this reason, its routine use has been limited in international guidelines for AU in cases where conventional urodynamics is insufficient in the diagnosis, by indicating its application. In the AU method, all physiopathological changes in the lower urinary system can be observed synchronously, since the bladder filling is orthograde, not retrograde, that is, the lower urinary system is examined while the physiological urine is filled, not liquid, and the patients can perform the activities they want, and the symptoms that occur during these activities can be recorded by the patient. Despite the advantages of performing it under these conditions, it takes a long time to be evaluated with 2-4 voiding cycles and is used as a second step in cases that cannot be diagnosed by conventional urodynamics. In the previous studies performed by us, it was seen that the results of the ambulatory urodynamic examination performed with a single voiding cycle were similar to the studies in the literature using multiple voiding cycles. However, at the moment, there is no study in the literature that determines the optimal duration of this test. For these reasons, this study aimed to compare the effectiveness of the test at the end of a single voiding cycle with that at the end of multiple (2 to 4) voiding cycles.
- Conditions
- Urodynamics, Urinary Incontinence, Urogenital Disease, Female, Lower Urinary Tract Symptoms
- Being tested
- Ambulatory Urodynamic Study
- Medical subject headings
- Urinary Incontinence, Female Urogenital Diseases, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory Urodynamic StudyDiagnostic test
Ambulatory urodynamic study is started after spontaneous diuresis of the patients. Ambulatory monitoring time is limited to each patient's own voiding cycle. The patient and a family member are instructed on the use of the event buttons on the patient module to flag incontinence, urgency, physical activity, and water drinking. With the use of catheters attached to microcomputers attached to their shoulders, patients are free to move around and engage in activities that may cause urinary incontinence. After voiding, the residual urine volume is first measured and then urethral and rectal catheters are placed. Monitoring is terminated when the patient feels that he cannot delay the urination sensation.Questionnaires that are routinely applied in our clinic will be applied in order to objectively evaluate the symptoms. Before urodynamics, urinary tract infection, whether symptomatic or not, must be routinely excluded with a complete urinalysis and urine culture.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients who underwent ambulatory urodynamic studies due to lower urinary tract symptoms Receives: Diagnostic Test: Ambulatory Urodynamic Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and feasibility
Determination of efficacy of single voiding cycle ambulatory urodynamics in diagnosis of lower urinary tract disorders by comparing number of incontinence and urgency episodes during the urodynamic study period
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study startFeb 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrodynamicsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulut Varlı, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666063
- Sponsor's protocol ID
- AmbulatoryUDS-1
- Status last verified
- Dec 2022
- First submitted
- 19 May 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Voiding Cycle and Two and Three Voiding Cycles in Ambulatory Urodynamic Studies
- ClinicalTrials.gov ID
- NCT05666063
- Acronym / sponsor ID
- AmbulatoryUDS-1
- Conditions
- Urodynamics, Urinary Incontinence, Urogenital Disease, Female, Lower Urinary Tract Symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 27 Dec 2022 (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 studies are objective diagnostic methods recommended and used in the evaluation and diagnosis of urinary incontinence, which is a very common problem that can significantly affect women's health and quality of life, cause social and economic losses. With these examinations, objective observation of bladder functions, repetition and classification of patients' symptoms, and identification of the underlying pathological cause, if possible, are provided in the evaluation of lower urinary system dysfunctions; In this way, the diagnosis is made, the choice of treatment is affected, the results of the treatment can be predicted and appropriate counseling can be given to the patients. Although conventional urodynamics is currently accepted as the gold standard test in the investigation of lower urinary tract symptoms, non-physiological retrograde bladder filling may adversely affect the test results and patients have to be under observation on the examination table while being examined with the conventional urodynamic method. Conventional method may not be effective enough in revealing the etiopathogenesis of lower urinary system symptoms, because they cannot perform activities where lower urinary system symptoms occur. Although many studies have shown that the diagnostic value of ambulatory urodynamics (AU) is higher in urogynecology clinical practice, it was not found suitable for routine investigation due to its longer duration, time-consuming and cost-effectiveness. For this reason, its routine use has been limited in international guidelines for AU in cases where conventional urodynamics is insufficient in the diagnosis, by indicating its application. In the AU method, all physiopathological changes in the lower urinary system can be observed synchronously, since the bladder filling is orthograde, not retrograde, that is, the lower urinary system is examined while the physiological urine is filled, not liquid, and the patients can perform the activities they want, and the symptoms that occur during these activities can be recorded by the patient. Despite the advantages of performing it under these conditions, it takes a long time to be evaluated with 2-4 voiding cycles and is used as a second step in cases that cannot be diagnosed by conventional urodynamics. In the previous studies performed by us, it was seen that the results of the ambulatory urodynamic examination performed with a single voiding cycle were similar to the studies in the literature using multiple voiding cycles. However, at the moment, there is no study in the literature that determines the optimal duration of this test. For these reasons, this study aimed to compare the effectiveness of the test at the end of a single voiding cycle with that at the end of multiple (2 to 4) voiding cycles.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Ambulatory Urodynamic StudyPatients who underwent ambulatory urodynamic studies due to lower urinary tract symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology with complicated urinary system symptoms detected by anamnesis and physical examination will be included.
Key inclusion criteria (9 listed)
- Age > 18 years
- No suspicion of pregnancy
- Adequate mental functions
- Cases of stress urinary incontinence not confirmed by cough testing
- Having inconsistent examination results
Key exclusion criteria (3 listed)
- Presence of active urinary tract infection
- Patients to be treated conservatively
- Presence of urinary retention
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 |
|---|---|---|
| Ambulatory Urodynamic StudyAmbulatory urodynamic study is started after spontaneous diuresis of the patients. Ambulatory monitoring time is limited to each patient's own voiding cycle. The patient and a family member are instructed on the use of the event buttons on the patient module to flag incontinence, urgency, physical activity, and water drinking. With the use of catheters attached to microcomputers attached to their shoulders, patients are free to move around and engage in activities that may cause urinary incontinence. After voiding, the residual urine volume is first measured and then urethral and rectal catheters are placed. Monitoring is terminated when the patient feels that he cannot delay the urination sensation.Questionnaires that are routinely applied in our clinic will be applied in order to objectively evaluate the symptoms. Before urodynamics, urinary tract infection, whether symptomatic or not, must be routinely excluded with a complete urinalysis and urine culture. | Diagnostic test | Study Group |
Primary outcome
Accuracy and feasibility
Time frame: 2 year
Determination of efficacy of single voiding cycle ambulatory urodynamics in diagnosis of lower urinary tract disorders by comparing number of incontinence and urgency episodes during the urodynamic study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Esra Cetinkaya, M.D. contact
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 Urodynamics and Urinary Incontinence, run by Ankara University at 1 site in Turkey (Türkiye).
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 9 inclusion and 3 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 28 Dec 2022. 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 Turkey (Türkiye). 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 Bulut Varlı, M.D. (00903125956405, bulutvarli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and feasibility (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2022.