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.
84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.
This study's enrollment of 130 is above the median of 101 across 66 interventional studies indexed under Ureterolithiasis.
Browse Ureterolithiasis studies →Aydin Adnan Menderes University is the lead sponsor of 241 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
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.
Ran from Jul 2025 to primary completion in Nov 2025, 4 months.
Results were first posted in Apr 2026, 4 months after primary completion.
Of 36 non-industry interventional studies with no phase under Ureterolithiasis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's 4 months is below that.
Counting every sponsor, half of 38 studies reached it within 20 months; a quarter within 11 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aydin Adnan Menderes University →