To study the role of Conventional urodynamics, video urodynamics, and ambulatory urodynamics in young males with lower urinary tract symptoms
Objectives:
Primary objective:
To compare the urodynamic parameters obtained through Conventional urodynamics, video urodynamics, and ambulatory urodynamics in young males with lower urinary tract symptoms

 Secondary objective:
1.	To identify the etiology of lower urinary tract symptoms in young males using Conventional urodynamics, video-urodynamics, and ambulatory urodynamics
2.	To study the success rate in follow-up in the form of changes in IPSS, IIEF-5 score and Post void residual volume using Conventional urodynamics, Video urodynamic, and ambulatory urodynamics-directed therapy.

Study Design-A prospective, single-institution, in-hospital, three arms randomized exploratory trial comparing the three groups- 
Group A-Conventional Urodynamic Study + Micturating Cystourethrogram
Group B- Video urodynamic Study
Group C- Ambulatory Urodynamic Study + Micturating Cystourethrogram
Sample size: - 
This was an exploratory randomized trial. The total number of participants (Men less than 40 years) coming with LUTS during the time period of the trial were allocated to various study arms. A total of 66 patients were taken during the study period and randomized to three arms. 
The study was designed to conform to the Declaration of Helsinki and ICMR guidelines for ethical biomedical research on human subjects. The trial was registered in CTRI (Clinical Trials Registry - India) with registration number CTRI/2020/09/027866. 
Sampling technique:
1.	Masking: Open-label 

2.	Method of Randomization: Randomization was generated by online random number generation (http://www.randomization.com)

3.	Allocation:  done by SNOOSE (sequentially numbered opaque sealed envelope) method

Materials and Methods
All young patients with LUTS (Age < =40 years) willing to take part were recruited from the institute. Patients were enrolled from July 2020 till may 2022. After fulfilling the inclusion and exclusion criteria, patients were enrolled in the study and written full informed consent was taken from each individual explaining the study's aim and objectives, plan, and duration in the language they best understand.
During recruitment, demographic and patient data were recorded.
Pre and Post UDS diagnoses were made.Conventional UDS, VUDS, and AUDS-directed treatment were given to the patient.Post-treatment follow-up at two weeks, four weeks, and six weeks was done using IPSS, IIEF-5 score, UDI-6, Uroflowmetry and USG KUB.
STATISTICAL ANALYSIS

Data Management: Data was entered in a Microsoft Excel spreadsheet. All care was taken to ensure that there was no data entry error.
Descriptive statistics: Categorical variables were described as frequency and proportion. Continuous variables were expressed as mean ± standard deviation or median with the inter-quartile range as applicable
Inferential statistics: Proportions were compared using the Chi-square test and Fisher's exact test as and when required. 
Primary objective: ANOVA and repeated measures ANOVA were used to compare means in more than two groups.
 The means in two groups were compared using students' t-test and Mann Whitney U test as applicable. ANOVA and repeated measures ANOVA were used to compare the change in the parameters. 
All the statistical tests were performed with a significance level of a=0.05 (95% C.I), and analysis was conducted using IBM SPSS STATISTICS (Version 25.0).

66 patients were randomized and participated in the study. These patients were randomized to three groups of 22 each: conventional urodynamics, video urodynamics, and ambulatory urodynamics. Baseline characters in terms of age, comorbidities, chief complaints, duration of symtoms were matched in all 3 groups.
A urodynamic diagnosis was established post urodynamics, and the treatment was based on the post-urodynamic diagnosis. A single urodynamic diagnosis was found in 73% of the patients, and a combined diagnosis was established in 27%.

1.   The treatment based on post UDS diagnosis resulted in significant improvement in symptoms among the three different modalities showing either modalities are non inferior to one another. 
2.	Urodynamics-based treatment helps in better management of the patient and relief of symptoms. Empirical treatment often leads to frustrating results and delays actual treatment.

Young men with LUTS are a distinct category of patients. The role of urodynamics in young men with LUTS is significant as it helps in establishing the appropriate diagnosis. The post UDS diagnosis results in appropriate management of the patient and successful treatment outcomes as is seen in this study. Therefore, Urodynamics can be an integral part of the evaluation of young men with LUTS.

.  Irwin DE, Milsom I, Kopp Z, Abrams P, Artibani W, Herschorn S. Prevalence, severity, and symptom bother of lower urinary tract symptoms among men in the EPIC study: impact of overactive bladder. Eur Urol. 2009;56(1):14-20. doi:10.1016/j.eururo.2009.02.026
Toh KL, Ng CK. Urodynamic studies in the evaluation of young men presenting with lower urinary tract symptoms. Int J Urol Off J Jpn Urol Assoc. 2006;13(5):520-523. doi:10.1111/j.1442-2042.2006.01347.

Continence 12S (2024) 101459
DOI: 10.1016/j.cont.2024.101459