Clinical trial NCT05666063: Comparison of Single Voiding Cycle and Two and Three Voiding Cycles in Ambulatory Urodynamic Studies
Official title: Comparison of Single Voiding Cycle and Two and Three Voiding Cycles in Ambulatory Urodynamic Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urodynamics
Urinary Incontinence
Urogenital Disease, Female
Lower Urinary Tract Symptoms
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. No suspicion of pregnancy
3. Adequate mental functions
4. Cases of stress urinary incontinence not confirmed by cough testing
5. Having inconsistent examination results
6. Significant urge, urge incontinence and/or overactive bladder complaints
7. Cases with mixed-type urinary incontinence with a predominant complaint of urgency
8. Those with a history of pelvic organ prolapse repair surgery
9. Those with a history of anti-incontinence surgery

Exclusion Criteria:

1. Presence of active urinary tract infection
2. Patients to be treated conservatively
3. Presence of urinary retention

Primary outcomes:
measure: Accuracy and feasibility
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
References: