Purpose: The urodynamic study is an invasive test, and causes pain and stress in the patient. We have investigated the effect of rectal midazolam sedation on the pain, stress, and cooperation of women performing urodynamic study. Materials and Methods: At the present randomized clinical trial (RCT) from January to July of 2021 a total of 84 women were prospectively randomized to undergo urodynamic study with or without sedation. The primary outcome of interest was experienced pain during urodynamic study. In the intervention group, after monitoring baseline vital signs (heart rate, blood pressure, O2 saturation), sedation was done with rectal midazolam at a dose of 0.3 mg/kg (maximum 15 mg). Completing the procedure, after recovery from sedation patients were asked to fill a self-assessed visual analog pain scale (VAS, 0-10), 5-point visual stress scale (1-5) and, patient collaboration level during urodynamic study was evaluated by nurse with a researcher-made tool (0-3). In the control group test was performed in routine practice with no sedation. Baseline vital signs measured pre and intra-procedural time, as well as their experienced pain, stress, and cooperation levels were recorded. Results: 84 female cases were evaluated. In terms of comparison of changes in pre and intra-test physiologic parameters, results showed that there were no significant differences between the two groups for all physiologic parameters: SBP, DBP, PR, SpO2. Analysis of the pain score showed that it was lower in the intervention group, and there was a significant difference in pain score between the two groups (P =.024). While the stress and corporation scores were not reported statistically significant (P=.388 and P=.955, respectively).
Conclusion: Sedation with rectal midazolam in adult women before UDS is safe and effective in reducing pain but is not effective in reducing stress and increasing cooperation. The amount of pain based on the visual analog pain scale is mild and although this method is safe, its use routinely is not recommended.