Comparison of 4.5/6.5F and 7.5/9.5F Ureteroscopes in Endoscopic Ureteral Stone Treatment

Aydin Adnan Menderes University

Status: Not yet enrolling

Conditions: Ureteroscopic Lithotripsy; Ureteral Stones

Treatments: Procedure: endoscopic ureteric lithotripsy

Study type: Observational

Funder types: Other

Identifiers

NCT06935500

decision:14 protocol no: 2025/

Details and patient eligibility

About

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.

Full description

Patients admitted to our clinic with ureteral calculi and scheduled for ureteroscopic lithotripsy will be informed about the procedure, potential complications, and routine protocol by the investigator. Patients who consent to the operation will subsequently receive detailed information about the study. Those agreeing to participate will provide written informed consent.

During the ureteroscopy procedure, standard clinical protocols will be followed. The choice of ureteroscope (4.5-6 Fr or 7.5-9.5 Fr) will be made by the operating urologist based on the patient's ureteral orifice and ureteral width. The study will not influence the selection of the ureteroscope. Intraoperative parameters, including procedure duration, complications, Double-J stent placement, failure to access the stone, and basket use, will be recorded by the research team.

To assess the impact of ureteroscope size on surgical stress, the operating surgeon's stress levels will be evaluated immediately before and after the procedure using the six-item short-form of the State Scale of the Spielberger State-Trait Anxiety Inventory (STAI).

Postoperatively, all patients undergoing ureteroscopic lithotripsy will undergo a supine direct abdominal radiograph on postoperative day 1, as per routine clinical practice. Stone-free status will be determined based on this radiograph and recorded by the investigator. Throughout the study period, no modifications to standard clinical procedures will be made.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

100 participants in 2 patient groups

4,5/6,5f URS

Description:

Group operated with 4.5/6.5f ureteroscope

Treatment:

Procedure: endoscopic ureteric lithotripsy

7,5/9,5f URS

Description:

Group operated with 7.5/9.5f ureteroscope

Treatment:

Procedure: endoscopic ureteric lithotripsy