Holmium Laser Versus Cold Knife Treatment in Urethral Strictures

April 16, 2026 updated by: Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex

Comparison of Holmium Laser Versus Cold Knife Treatment in Patients With Urethral Strictures

The goal of this study is to assess the efficacy of optical internal urethrotomy, which uses a holmium laser in comparison to a cold knife, in treating short-segment urethral strictures in our local setting. The study will help standardize treatment protocols for urethral stricture based on functional results. The local findings will encourage adoption of minimally invasive laser techniques in public hospitals, improving access to modern urologic care. The study will help in informed decision making, enabling patients to understand treatment options and their expected outcomes based on evidence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Urethral stricture, one of the earliest known urologic conditions, is still prevalent and challenging to cure. It is a common illness with a high morbidity rate; its estimated frequency is around 0.6% in industrialized areas and may be higher in developing regions. The various therapeutic options are influenced by depth, location, and length of scarring of stricture. These include electrocautery, cold-knife urethrotomy, and other laser treatments.3 These have gained particular popularity in the last 20 years.

A cold-knife incision may cause mechanical injuries that could lead to recurrence while preventing thermal damage to the surrounding tissues. On the other hand, recurrence of strictures and severe heat injury are possible outcomes of electrocautery. The Holmium:YAG (Ho:YAG) laser has been the most widely used laser treatment in recent years due to its precision and efficacy. After carefully advancing the Sachse Urethrotome to the stricture site, the stricture is incised using the 12 o'clock position technique until it is sufficiently treated.6 A range of lasers, such as carbon dioxide, argon, yttrium aluminum-garnet (YAG), neodymium (Nd), and holmium (Ho):YAG, are also used to treat the urethral strictures. The Ho:YAG laser is gaining popularity as an endourology method due to its high precision and minimal heat impact on surrounding tissues.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Bahawalpur, Punjab Province, Pakistan, 60000
        • Kidney Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Males aged 18 to 70 years with short segment urethral strictures (length <2 cm), planned to undergo internal urethrotomy

Exclusion Criteria:

  • Patients with multiple or recurrent strictures, those with active urinary tract infections, complete urethral obliteration on urethroscopy, with pan-anterior strictures, posterior stenosis, failed prior interventions, or lichen sclerotic changes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Holmium laser
in holmium laser urethrotomy procedure, a laser fiber is passed through a cystoscope, and precise incisions are made in the stricture, usually at the 12 o'clock position, to widen the lumen
Device: holmium laser
in holmium laser urethrotomy procedure, a laser fiber is passed through a cystoscope, and precise incisions are made in the stricture, usually at the 12 o'clock position, to widen the lumen
Placebo Comparator: cold knife
In cold-knife urethrotomy procedure, a cystoscope is passed into the urethra, and a cold knife is utilized for incising the stricture at 12 o'clock position to widen the narrowed lumen to restore normal urine flow
Device: cold knife
In cold-knife urethrotomy procedure, a cystoscope is passed into the urethra, and a cold knife is utilized for incising the stricture at 12 o'clock position to widen the narrowed lumen to restore normal urine flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Peak urinary flow rate
Time Frame: 30 days
Urinary flow in ml/sec will be measured on uroflowmetry on enrollment and 30-days post-operatively
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahida Islam Medical Complex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Actual)

March 14, 2026

Study Completion (Actual)

March 15, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kidney centre, BWP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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