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CompletedNCT06975488LASERUpdated May 16, 2025

Effectiveness of LASER in Treatment of Ureteric Stones.

An interventional study of LASER Lithotripsy ( Fragmentation modality) and LASER lithotripsy (Dusting Modality) in Ureteric Stone, sponsored by District Headquarters Teaching Hospital Sahiwal. Completed at 1 site in Pakistan. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by District Headquarters Teaching Hospital Sahiwal · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
15 Years to 70 Years
Sex
All
01

Study summary

Ureteroscopic laser lithotripsy is becoming the most commonly utilized treatment for patients with ureteral stone. The Holmium: YAG laser is integral to the operation and is the preferred flexible intracorporeal lithotripsy. It is considered cost-effective and efficient choice in ureteroscopic lithotripsy on all types of stones. As in recent years, there has been increasing interest in examining the effect of varying the laser settings on the effectiveness of stone treatment. The objective of the study is to compare the fragmentation and dusting modalities utilizing Holmium YAG laser in ureteroscopy for ureteral stone treatment. It will be a randomized control trial (RCT) in which 160 patients visiting Sahiwal Teaching Hospital, Sahiwal will be included. The patients will be divided into two groups. Group-A patients will be treated with fragmentation modality utilizing Holmium YAG laser while Group-B patients will be treated with dusting modality utilizing Holmium YAG laser. Simple random sampling technique will be carried out. The patients' age, gender, stone number, stone laterality, stone location, ureteral condition, reteropulsion, stricture formation, stone clearance, operative time, hospital stay, presence of retropulsion and complications will be recorded. Data will be collected through proforma, which will be entered and analyzed using SPSS version 26.0. For quantitative variables such as: age, operation time, hospital stay, stone number ,mean and standard deviation will be calculated and for qualitative variables such as: gender, and laterality, stone location, ureter condition, prevalence of pyuria, stone clearance, presence of retropulsion, ureter injury, frequency and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. Chi-square test will be used to estimate the association between study variables. P-value \<0.05 will be considered significant. It is anticipated that the results of this study will be helpful for health care planners and surgeons to provide better treatment option to the patients with ureteral stone.

02

Conditions studied

  • Ureteric Stone

Keywords

  • Laser
  • URS
  • DJ Stent
  • Lithotripsy
  • ESWL
  • URSL
03

Who can participate

Ages eligible
15 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Stone size 1cm to 1.5cm at proximal Ureter.
  2. Patients aged between 15 to 70 years.
  3. Both genders.

Exclusion criteria

Exclusion Criteria:

  1. Patients with active urinary tract infection
  2. Pregnancy
  3. Immunocompromised patients
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Group A

    Group A patients will be treated with fragmentation modality utilizing Holmium YAG laser.

    Procedure: LASER Lithotripsy ( Fragmentation modality)

  • Experimental
    Group B

    Group B patients will be treated with dusting modality utilizing Holmium YAG laser.

    Procedure: LASER lithotripsy (Dusting Modality)

Interventions

  • ProcedureLASER Lithotripsy ( Fragmentation modality)

    Group-A patients will be treated with fragmentation modality utilizing Holmium YAG laser.

  • ProcedureLASER lithotripsy (Dusting Modality)

    Group-B patients will be treated with dusting modality utilizing Holmium YAG laser.

05

What researchers measure

Primary outcomes

  1. Stone Free Rate

    Stone-free will be defined as no residual stones \> 3 mm in the ureter of the affected side at one month postoperatively on computerized tomography (CT KUB Plain).

    Time frame: There would be 4 follow up visits. First visit will be after 1 week of URSL and X Ray KUB will be done. Second visit will be after 2 weeks of URSL and we will plan the removal of DJ stent. Those cases in which ureteral inury is suspected or stone burden

  2. Reteropulstion

    Retropulsion, defined as unintended migration of stone into the kidney, leads to failure and results in a lower SFR.

    Time frame: During procedure.

Secondary outcomes

  1. Uretral Stricture Formation

    Post-URS ureteral stricture is defined as complete or partial ureteral obstruction as shown by the excretory phase of CTU, which was confirmed with delayed or absent radioactive tracer washout at 8 weeks after stent removal.

    Time frame: Post-URS ureteral stricture is defined as complete or partial ureteral obstruction as shown by the excretory phase of CTU, which was confirmed with delayed or absent radioactive tracer washout at 8 weeks after stent removal.

06

Study locations

1 site
  • District Headquarters Teaching Hospital Sahiwal
    Sahiwal, Punjab 57000, Pakistan
07

References and documents

Publications

  • Chen BH, Lin TF, Tsai CC, Chen M, Chiu AW. Comparison of Fragmentation and Dusting Modality Using Holmium YAG Laser during Ureteroscopy for the Treatment of Ureteral Stone: A Single-Center's Experience. J Clin Med. 2022 Jul 17;11(14):4155. doi: 10.3390/jcm11144155. PubMed 35887919 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06975488
Lead sponsor
District Headquarters Teaching Hospital Sahiwal
Responsible party
Ussama Iftikhar (Resident, District Headquarters Teaching Hospital Sahiwal) — Principal investigator
First posted
May 16, 2025
Start date
Apr 14, 2024
Primary completion
Apr 13, 2025
Completion
Apr 20, 2025
Last update
May 16, 2025

Study contacts

U A IFTIHKAR, MS
principal investigator · District Headquarters Teaching Hospital Sahiwal
A RIAZ, MD
study director · Sahiwal medical college sahiwal

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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