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Holmium Laser Versus Cold Knife Treatment in Urethral Strictures

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07505316
Enrollment
60
Registered
2026-04-01
Start date
2026-01-15
Completion date
2026-03-15
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stricture Urethra, Holmium Laser, Recurrence

Keywords

stricture urethra, cold knife, holmium laser

Brief summary

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.

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.

Interventions

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

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

Sponsors

Shahida Islam Medical Complex
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Peak urinary flow rate30 daysUrinary flow in ml/sec will be measured on uroflowmetry on enrollment and 30-days post-operatively

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026