Ureteral StonesNCT06935500

Ureteroscope Caliber and Surgeon Stress

A study testing endoscopic ureteric lithotripsy in people with Ureteral Stones and Ureteroscopic Lithotripsy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ureteral Stones, Ureteroscopic Lithotripsy
What is being tested?: endoscopic ureteric lithotripsy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 10 Jul 2025to 15 Nov 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Presence of ureteral calculi
Use of Ho:YAG laser in ureteric lithotripsy
Patient's acceptance to participate in the study

Who cannot join

Presence of active urinary tract infection
Emergency operation of the patient
Presence of bilateral ureteral calculi
Patient refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Aydın State Hospital
Aydin, Aydın, 09100

Other trials in Turkey (Türkiye)

About this study

Official title: Impact of Semirigid Ureteroscope Caliber on Perioperative Outcomes and Surgeon Stress

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.

Read the detailed description

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.

Conditions: Ureteral Stones, Ureteroscopic Lithotripsy
Being tested: endoscopic ureteric lithotripsy
Keywords: ureteral stone, anxiety inventory, ureteroscoppic lithotripsy, ureteroscop
Medical subject headings: Ureterolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

endoscopic ureteric lithotripsyProcedure or surgery
2 different sizes of ureteroscopes, 4.5/6.5f and 8/9.8f, will be used in the study.

Study groups in NCT06935500
Study group	Role	What they receive
4,5/6,5f URS	Experimental	Group operated with 4.5/6.5f ureteroscope Receives: Procedure: endoscopic ureteric lithotripsy
8/9,8f URS	Active comparator	Group operated with 8/9.8f ureteroscope Receives: Procedure: endoscopic ureteric lithotripsy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Immediately before and immediately after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202515 Nov 2025

First posted20 Apr 2025
Study start10 Jul 2025
Primary completion15 Nov 2025
Study completion15 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Ureteral StonesStudies of the same condition, open and under way.
More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06935500
Sponsor's protocol ID: decision:14 protocol no: 2025/
Status last verified: Jul 2026
First submitted: 3 Apr 2025
Last updated: 19 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: It is not planned to share individual participant data unless specifically requested by the journal in which the study will be published.

Publications

Jones KI, Amawi F, Bhalla A, Peacock O, Williams JP, Lund JN. Assessing surgeon stress when operating using heart rate variability and the State Trait Anxiety Inventory: will surgery be the death of us? Colorectal Dis. 2015 Apr;17(4):335-41. doi: 10.1111/codi.12844.
PubMed 25406932
Omar M, Dorrah M, Khalifa A, El Sherif E, Sayedahmed K, Ghazwani Y, Noureldin YA. Randomized comparison of 4.5/6 Fr versus 6/7.5 Fr ureteroscopes for laser lithotripsy of lower/middle ureteral calculi: towards optimization of efficacy and safety of semirigid ureteroscopy. World J Urol. 2022 Dec;40(12):3075-3081. doi: 10.1007/s00345-022-04173-2. Epub 2022 Oct 8.
PubMed 36208314
Uzun H, Akca N. Is the 4.5-F ureteroscope (Ultra-Thin) an alternative in the management of ureteric and renal pelvic stones? Arab J Urol. 2018 Jun 21;16(4):429-434. doi: 10.1016/j.aju.2018.04.006. eCollection 2018 Dec.
PubMed 30534443
Atis G, Arikan O, Gurbuz C, Yildirim A, Erol B, Pelit S, Ulus I, Caskurlu T. Comparison of different ureteroscope sizes in treating ureteral calculi in adult patients. Urology. 2013 Dec;82(6):1231-5. doi: 10.1016/j.urology.2013.07.021. Epub 2013 Sep 12.
PubMed 24035032

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ureteral Stones trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Semirigid Ureteroscope Caliber on Perioperative Outcomes and Surgeon Stress
ClinicalTrials.gov ID: NCT06935500
Acronym / sponsor ID: decision:14 protocol no: 2025/
Conditions: Ureteral Stones, Ureteroscopic Lithotripsy
Keywords: ureteral stone, anxiety inventory, ureteroscoppic lithotripsy, ureteroscop
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Aydin Adnan Menderes UniversityUniversity, hospital or other
Study start: 10 Jul 2025 (actual)
Primary completion: 15 Nov 2025 (actual)
Study completion: 15 Nov 2025 (actual)
First posted: 20 Apr 2025 (actual)
Results: Posted 13 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
4,5/6,5f URS	Experimental	Procedure: endoscopic ureteric lithotripsyGroup operated with 4.5/6.5f ureteroscope
8/9,8f URS	Active comparator	Procedure: endoscopic ureteric lithotripsyGroup operated with 8/9.8f ureteroscope

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Presence of ureteral calculi
Use of Ho:YAG laser in ureteric lithotripsy
Patient's acceptance to participate in the study

Key exclusion criteria (4 listed)

Presence of active urinary tract infection
Emergency operation of the patient
Presence of bilateral ureteral calculi
Patient refusal to participate in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
endoscopic ureteric lithotripsy2 different sizes of ureteroscopes, 4.5/6.5f and 8/9.8f, will be used in the study.	Procedure or surgery	4,5/6,5f URS, 8/9,8f URS

Primary outcome

Change in STAI-TX1 Score (Postoperative - Preoperative)
Time frame: Immediately before and immediately after the procedure
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.

Results and safety

Results posted to the registry on 13 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
4,5/6,5f URS Group	65	65
8/9,8f URS	65	65

Primary outcome: Change in STAI-TX1 Score (Postoperative - Preoperative)

Time frame: Immediately before and immediately after the procedure. Mean (Standard Deviation). Unit: Scores on a scale

Measure	4,5/6,5f URS n = 65	8/9,8f URS n = 65
Value	1.35 (4.4)	5.05 (9.6)

Population analysed: 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).

Adverse events

Time frame: From the start of the procedure until hospital discharge (typically within 1-2 days postoperatively). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
4,5/6,5f URS	0 of 65 (0%)	6 of 65 (9.2%)	0 of 65
8/9,8f URS	0 of 65 (0%)	15 of 65 (23.1%)	0 of 65

Limitations and caveats (from the sponsor): No interpretative statements are provided in this section. All results are presented in the corresponding outcome measure data tables.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25406932Jones KI, Amawi F, Bhalla A, Peacock O, Williams JP, Lund JN. Assessing surgeon stress when operating using heart rate variability and the State Trait Anxiety Inventory: will surgery be the death of us? Colorectal Dis. 2015 Apr;17(4):335-41. doi: 10.1111/codi.12844.
Background: PubMed 36208314Omar M, Dorrah M, Khalifa A, El Sherif E, Sayedahmed K, Ghazwani Y, Noureldin YA. Randomized comparison of 4.5/6 Fr versus 6/7.5 Fr ureteroscopes for laser lithotripsy of lower/middle ureteral calculi: towards optimization of efficacy and safety of semirigid ureteroscopy. World J Urol. 2022 Dec;40(12):3075-3081. doi: 10.1007/s00345-022-04173-2. Epub 2022 Oct 8.
Background: PubMed 30534443Uzun H, Akca N. Is the 4.5-F ureteroscope (Ultra-Thin) an alternative in the management of ureteric and renal pelvic stones? Arab J Urol. 2018 Jun 21;16(4):429-434. doi: 10.1016/j.aju.2018.04.006. eCollection 2018 Dec.
Background: PubMed 24035032Atis G, Arikan O, Gurbuz C, Yildirim A, Erol B, Pelit S, Ulus I, Caskurlu T. Comparison of different ureteroscope sizes in treating ureteral calculi in adult patients. Urology. 2013 Dec;82(6):1231-5. doi: 10.1016/j.urology.2013.07.021. Epub 2013 Sep 12.
Individual participant dataSharing planned: No. It is not planned to share individual participant data unless specifically requested by the journal in which the study will be published.

Related trials for Ureteral Stones

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Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GÖKHAN ŞAHİN study chair

Aydin Adnan Menderes University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing endoscopic ureteric lithotripsy in people with Ureteral Stones and Ureteroscopic Lithotripsy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in STAI-TX1 Score (Postoperative - Preoperative) (time frame: Immediately before and immediately after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06935500, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.