Holmium Laser Versus Cold Knife Treatment in Urethral Strictures

NCT07505316 | Completed DMC

• 1 other identifier: kidney centre, BWP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stricture Urethra; Holmium Laser; Recurrence

Keywords

stricture urethra; cold knife; holmium laser

Outcome Measures

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

  30 days

Study Arms (2)

Holmium laser

EXPERIMENTAL

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

cold knife

PLACEBO COMPARATOR

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

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

Holmium laser

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

cold knife

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: male genders
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahida Islam Medical Complex: lead

Study Sites (1)

Kidney Centre

Bahawalpur, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Urethral Stricture; Recurrence

Interventions

Lasers, Solid-State; Conization

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: January 15, 2026
• Primary Completion: March 14, 2026
• Study Completion: March 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)