An interventional study of endoscopic ureteric lithotripsy in Ureteral Stones and Ureteroscopic Lithotripsy, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Treatment
This study aims to compare the efficacy, success rates, and stone-free rates of endoscopic ureteral stone treatment performed using two different sizes of ureteroscopes. Additionally, the psychological stress experienced by the surgeon will be evaluated immediately before and immediately after the procedure using the six-item short-form of the State Scale of the Spielberger State-Trait Anxiety Inventory (STAI). The findings will provide insight into the impact of ureteroscope size on procedural outcomes and surgeon stress levels, contributing to the optimization of ureteroscopic stone treatment.
Patients admitted to our clinic with ureteral calculi and scheduled for ureteroscopic lithotripsy were informed about the procedure, potential complications, and routine clinical protocol. Patients who consented to surgery subsequently received detailed information about the study, and written informed consent was obtained from those who agreed to participate.
Participants were randomly assigned in a 1:1 ratio to undergo ureteroscopy using either a 4.5-6.5 Fr semirigid ureteroscope or an 8-9.8 Fr semirigid ureteroscope. Randomization was performed using a computer-generated simple randomization sequence. Group allocation was concealed using sequentially numbered opaque sealed envelopes, which were opened immediately before the procedure.
All ureteroscopic procedures were performed according to standard institutional protocols. Intraoperative parameters, including operative duration, complications, double-J stent placement, failure to access the stone, and basket use, were recorded prospectively by the research team.
To evaluate the impact of ureteroscope caliber on surgical stress, the operating surgeon's stress level was assessed immediately before and after each procedure using the State-Trait Anxiety Inventory Form TX-1 (STAI-TX1).
Postoperatively, all patients underwent supine direct abdominal radiography on postoperative day one in accordance with routine clinical practice. Stone-free status was determined based on radiographic evaluation and recorded by the investigator. No modifications were made to standard perioperative care during the study period.
Exclusion Criteria:
Group operated with 4.5/6.5f ureteroscope
Procedure: endoscopic ureteric lithotripsy
Group operated with 8/9.8f ureteroscope
Procedure: endoscopic ureteric lithotripsy
2 different sizes of ureteroscopes, 4.5/6.5f and 8/9.8f, will be used in the study.
Change in STAI-TX1 Score (Postoperative - Preoperative)
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.
Time frame: Immediately before and immediately after the procedure
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.
| Milestone | 4,5/6,5f URS Group | 8/9,8f URS |
|---|---|---|
| Started | 65 | 65 |
| Completed | 65 | 65 |
| Not completed | 0 | 0 |
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.
| Scores on a scale | 4,5/6,5f URS | 8/9,8f URS |
|---|---|---|
| Change in STAI-TX1 Score (Postoperative - Preoperative) | 1.35 ± 4.4 | 5.05 ± 9.6 |
Collected over From the start of the procedure until hospital discharge (typically within 1-2 days postoperatively). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4,5/6,5f URS | 0/65 (0%) | 0/65 (0%) | 6/65 (9.2%) |
| 8/9,8f URS | 0/65 (0%) | 0/65 (0%) | 15/65 (23.1%) |
| Event | 4,5/6,5f URS | 8/9,8f URS |
|---|---|---|
| mild hematuriaRenal and urinary disorders | 4/65 | 10/65 |
| renal colicRenal and urinary disorders | 4/65 | 6/65 |
There is no missing data in the study.
| Age, Categorical(Participants) | 4,5/6,5f URS Group | 8/9,8f URS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 55 | 57 | 112 |
| >=65 years | 10 | 8 | 18 |
| Sex: Female, Male(Participants) | 4,5/6,5f URS Group | 8/9,8f URS | Total |
|---|---|---|---|
| Female | 25 | 23 | 48 |
| Male | 40 | 42 | 82 |
| Race and Ethnicity Not Collected(Participants) | 4,5/6,5f URS Group | 8/9,8f URS | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Plan to share: No — It is not planned to share individual participant data unless specifically requested by the journal in which the study will be published.
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Aydin Adnan Menderes University