Hypothesis / aims of study
To Study Role of Ambulatory Urodynamics in females with lower urinary tract symptoms in terms of treatment outcomes, Diagnostic accuracy, and patient anxiety.
Objectives:
Primary objective:
• To compare treatment outcomes using Video and Ambulatory Urodynamic Study as Diagnostic modalities in Female Lower Urinary tract symptoms.
Secondary objective:
• To Study the correlation between pre and post urodynamic diagnosis using VUDS and AUDS in females with lower urinary tract symptoms.
• To study Patient reported outcomes using Visual analogue scale
Study design, materials and methods
Study Design- Prospective Observational Study
Materials and Methods
All Female patients with lower urinary tract symptoms undergoing UDS were evaluated using detailed history and examination from July 2023 till February 2024. Patient were allocated to either arm- VUDS or AUDS with MCU. Pre and post UDS diagnosis and anxiety faced by patients during UDS (assessed using Global anxiety Visual analogue scale- GA VAS) were compared. Patients were started on treatment based on Post UDS diagnosis. Post treatment follow up was done after 1 month with Uroflowmetry with PVR, IPSS, ICIQ- FLUTS score.
Data was entered in a Microsoft Excel spreadsheet. All care was taken to ensure that there was no data entry error. 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. Proportions were compared using the Chi-square test and Fisher's exact test as and when required. 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).
Objective Criteria of Treatment Success
• Change in ICIQ-FLUTS Score (change of more than 3-treatment success)
• Change in IPSS Score (change of more than or equal to 4-treatment success)
• Improvement in Voiding Efficiency
Sample Size- Based on study done comparing AUDS and conventional UDS total sample size calculated is 52 (26 in each group) with 95% confidence interval and 80% power of study. (1)
Sampling Technique- Simple Random Sampling
Results
On interim analysis- 30 females undergoing UDS were included in study, 15 underwent AUDS + MCU and 15 underwent VUDS. Among patients undergoing AUDS + MCU- Diagnosis- Bladder Outlet Obstruction-4, Neurogenic Bladder-2 Complicated SUI-2, Underactive bladder-3, OAB- 4, VUDS- Diagnosis- Bladder Outlet Obstruction-4, Neurogenic Bladder-2, Complicated SUI-4, Underactive bladder-3, OAB-2. Average improvement in IPSS, ICIQ-FLUTS, Voiding efficiency, PVR in AUDS +MCU group was 4, 4.2, 2.5%, 24ml. Average improvement in IPSS, ICIQ-FLUTS, Voiding efficiency, PVR in VUDS group was 5, 4.5, 2 %, 60ml. Differences were not statistically significant. 13 patients in AUDS + MCU group post UDS diagnosis was in concurrence with Pre UDS diagnosis whereas in VUDS number was 14. Patients undergoing VUDS complaint of more anxiety according to GA VAS- 7.8 compared to AUDS + MCU group(GA VAS- 6)
Interpretation of results
Ambulatory UDS based diagnosis lead to comparable improvement in symptoms of females of lower urinary tract symptoms compared to VUDS however patients undergoing AUDS experienced less anxiety compared to VUDS group although difference was not statistically significant.