Trial Outcomes & Findings for Ureteroscope Caliber and Surgeon Stress (NCT NCT06935500)
NCT ID: NCT06935500
Last Updated: 2026-04-13
Results Overview
The State-Trait Anxiety Inventory (STAI), Form TX-1, is a validated instrument used to assess situational (state) anxiety. The STAI-TX1 consists of 20 items scored on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate greater levels of anxiety. In this study, the STAI-TX1 was administered immediately before and immediately after each procedure. A change score (ΔSTAI-TX1) was calculated by subtracting the preoperative score from the postoperative score (postoperative minus preoperative). Positive values (ΔSTAI-TX1 \> 0) indicate an increase in anxiety, whereas values ≤ 0 indicate no increase or a decrease in anxiety.
COMPLETED
130 participants
Immediately before and immediately after the procedure
2026-04-13
Participant Flow
After obtaining local ethics committee approval, patients who presented to the urology pool clinic with ureteral stones and were scheduled for ureteroscopy were included in the study. Following the latest gpower analysis, it was decided to include 65 patients in each of the two groups.
Patients were divided into two groups using a simple 1:1 randomization method. Patients scheduled for ureteroscopy were evaluated for participation in the study, and those who underwent ureteroscopy were included. There is no missing data.
Participant milestones
| Measure |
4,5/6,5f URS Group
group in which 4.5/6.5f ureteroscope was used during ureteroscopy surgery.
|
8/9,8f URS
Group operated with 8/9.8f ureteroscope
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
4,5/6,5f URS Group
n=65 Participants
group in which 4.5/6.5f ureteroscope was used during ureteroscopy surgery.
|
8/9,8f URS
n=65 Participants
Group operated with 8/9.8f ureteroscope
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=65 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=130 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=65 Participants
|
57 Participants
n=65 Participants
|
112 Participants
n=130 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=65 Participants
|
8 Participants
n=65 Participants
|
18 Participants
n=130 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=65 Participants
|
23 Participants
n=65 Participants
|
48 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=65 Participants
|
42 Participants
n=65 Participants
|
82 Participants
n=130 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Immediately before and immediately after the procedurePopulation: All randomized participants were included in the analysis. The analysis population corresponds to the total number of participants assigned to each group (n=65 per group).
The State-Trait Anxiety Inventory (STAI), Form TX-1, is a validated instrument used to assess situational (state) anxiety. The STAI-TX1 consists of 20 items scored on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate greater levels of anxiety. In this study, the STAI-TX1 was administered immediately before and immediately after each procedure. A change score (ΔSTAI-TX1) was calculated by subtracting the preoperative score from the postoperative score (postoperative minus preoperative). Positive values (ΔSTAI-TX1 \> 0) indicate an increase in anxiety, whereas values ≤ 0 indicate no increase or a decrease in anxiety.
Outcome measures
| Measure |
4,5/6,5f URS
n=65 Participants
Group operated with 4.5/6.5f ureteroscope
|
8/9,8f URS
n=65 Participants
Group operated with 8/9.8f ureteroscope
|
|---|---|---|
|
Change in STAI-TX1 Score (Postoperative - Preoperative)
|
1.35 Scores on a scale
Standard Deviation 4.4
|
5.05 Scores on a scale
Standard Deviation 9.6
|
Adverse Events
4,5/6,5f URS
8/9,8f URS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
4,5/6,5f URS
n=65 participants at risk
Group operated with 4.5/6.5f ureteroscope
|
8/9,8f URS
n=65 participants at risk
Group operated with 8/9.8f ureteroscope
|
|---|---|---|
|
Renal and urinary disorders
mild hematuria
|
6.2%
4/65 • From the start of the procedure until hospital discharge (typically within 1-2 days postoperatively)
Adverse events were prospectively recorded during the intraoperative and postoperative periods. Complications were classified according to the Traxer classification for ureteral injury and the Clavien-Dindo classification for postoperative complications. All adverse event data are reported in the corresponding tables.
|
15.4%
10/65 • From the start of the procedure until hospital discharge (typically within 1-2 days postoperatively)
Adverse events were prospectively recorded during the intraoperative and postoperative periods. Complications were classified according to the Traxer classification for ureteral injury and the Clavien-Dindo classification for postoperative complications. All adverse event data are reported in the corresponding tables.
|
|
Renal and urinary disorders
renal colic
|
6.2%
4/65 • From the start of the procedure until hospital discharge (typically within 1-2 days postoperatively)
Adverse events were prospectively recorded during the intraoperative and postoperative periods. Complications were classified according to the Traxer classification for ureteral injury and the Clavien-Dindo classification for postoperative complications. All adverse event data are reported in the corresponding tables.
|
9.2%
6/65 • From the start of the procedure until hospital discharge (typically within 1-2 days postoperatively)
Adverse events were prospectively recorded during the intraoperative and postoperative periods. Complications were classified according to the Traxer classification for ureteral injury and the Clavien-Dindo classification for postoperative complications. All adverse event data are reported in the corresponding tables.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place