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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Bulut Varlı, M.D. contact

00903125956405

bulutvarli@gmail.com

Esra Cetinkaya, M.D. contact

esrascetinkaya@yahoo.com

Turkey (Türkiye)1 site
  • Ankara University

    Ankara

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05666063
Study groupRoleWhat they receive
Study GroupPatients 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.

  1. 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.

  1. First posted27 Dec 2022
  2. Study startFeb 2023 (estimated)
  3. Primary completionFeb 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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)
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

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.

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