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CompletedNCT07505316Updated Apr 21, 2026

Holmium Laser Versus Cold Knife Treatment in Urethral Strictures

An interventional study of holmium laser and cold knife in Stricture Urethra, Holmium Laser and Recurrence, sponsored by Shahida Islam Medical Complex. Completed at 1 site in Pakistan. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Shahida Islam Medical Complex · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Stricture Urethra
  • Holmium Laser
  • Recurrence

Keywords

  • stricture urethra
  • cold knife
  • holmium laser
03

In context

Urethral Stricture

72 studies on the registry are indexed under Urethral Stricture; 25 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 56 interventional studies indexed under Urethral Stricture.

Browse Urethral Stricture studies →

Lead sponsor

Shahida Islam Medical Complex is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Deviceholmium 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

  • Devicecold 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

06

What researchers measure

Primary outcomes

  1. Mean Peak urinary flow rate

    Urinary flow in ml/sec will be measured on uroflowmetry on enrollment and 30-days post-operatively

    Time frame: 30 days

07

Study locations

1 site
  • Kidney Centre
    Bahawalpur, Punjab Province 60000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07505316
Lead sponsor
Shahida Islam Medical Complex
Responsible party
Dr Mudassar Saeed Pansota (Associate Professor, Shahida Islam Medical Complex) — Principal investigator
First posted
Apr 1, 2026
Start date
Jan 15, 2026
Primary completion
Mar 14, 2026
Completion
Mar 15, 2026
Last update
Apr 21, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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