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NCT Number: NCT07505316

Holmium Laser Versus Cold Knife Treatment in 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.

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Key information

Conditions

Stricture Urethra Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Holmium Laser Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urethral Diseases Urethral Obstruction Urethral Stricture Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kidney Centre

Bahawalpur, Punjab Province, 60000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

holmium laser

Device

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

cold knife

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Shahida Islam Medical Complex

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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