Holmium: YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures

Holmium: YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures: A Randomized Controlled Trial

Urethral stricture disease is defined as narrowing of the urethral lumen because of fibrosis, which occurs in urethral mucosa and surrounding tissues. The etiology could be congenital, iatrogenic, infectious, or idiopathic.

Several techniques are currently available for minimally invasive treatment of urethral strictures, including cold-knife incision, electrocautery, and various types of laser incisions. An incision with the cold knife does not cause any thermal effect on surrounding tissues but should create a mechanical injury that may lead to recurrence in long term. An incision with the electrocautery should cause a significant thermal effect on healthy surrounding tissues resulting in recurrent strictures during follow-up. Laser treatment modalities have gained popularity in the last two decades.

the aim of this trial is to evaluate the safety and efficacy of endo-urethrotomy with Holmium laser and cold knife endo-urethrotomy

Study Overview

• Status: Completed
• Conditions: Urethral Stricture, Male
• Intervention / Treatment: Procedure: visualized internal urethrotomy

Detailed Description

Urethral stricture disease (USD) is the narrowing of the urethra from scar tissue, related to genitourinary tract infections, inflammatory skin conditions, traumatic urethral injury, pelvic radiation, and urinary tract instrumentation. It has an estimated prevalence rate of 0.6%.1-3 USD is a common and challenging problem for urologists. Multiple treatment modalities are available for the management of urethral strictures depending on the site and length of stricture, this includes simple urethral dilatation, urethral stenting, endoscopic visual internal urethrotomy (VIU), or open reconstruction.

Since 1974, Sachse's internal urethrotomy has been considered the treatment of choice for USD which is fast and simple to carry out and is associated with a short recovery time. The success rates are 33%-60%.

Bulow et al in 1979 introduced the laser for internal urethrotomy. The obvious dominance of Ho: YAG are clear vision, less bleeding, precise incision and ablation of scar tissue, and short hospital admission, however, most literature assessing the adequacy of the laser in contrast to cold-knife urethrotomy show no difference in final results.

The aim of this trial is to assess the efficacy, safety, complications, and results of Holmium laser urethrotomy and cold knife internal urethrotomy for urethral stricture.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11361
    • Urology department - ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• men with urethral stricture above the age of eighteen were included in our trial. the length of the urethral stricture was less than 1.5 cm.

Exclusion Criteria:

• patient with complete urethral stricture with a suprapubic catheter in place.
• patients whom internal urethrotomy is not applicable like multiple urethral strictures or balanitis xerotica obliterans.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: internal urethrotomy using Holmium laser representing group; In group 1, a three hundred micron laser fiber was used to conduct the laser energy. holmium laser pulse energy of approximately 1 joule was used that was generated from a Holmium laser Quanta device and total power of 15 watts. the laser fiber was aimed directly to the midline at 12 o'clock position to start the procedure and cut the fibrous tissue till access to a wide lumen.	Procedure: visualized internal urethrotomy; incision of a urethral stricture to treat urinary obstruction using Quanta Holmium device or Sache cold knife, 18 Fr silicon catheter was kept for 7 days following the prodecure.
Active Comparator: internal urethrotomy with Sachs cold knife; In group B, Sache cold knife internal urethrotomy was used with the same technique as Holmium laser internal urethrotomy at the same site to mechanically cut instead of the laser fiber.	Procedure: visualized internal urethrotomy; incision of a urethral stricture to treat urinary obstruction using Quanta Holmium device or Sache cold knife, 18 Fr silicon catheter was kept for 7 days following the prodecure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum flow rate (ml/sec.)	maximum flow rate, uroflow finding (ml/sec.)	at 3 months
Maximum flow rate(ml/sec.)	maximum flow rate, uroflow finding (ml/sec.)	at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time in minutes	time of operation from cystoscopy till catheter insertion	intraoperative finding
number of patients with bleeding per urethra	postoperative bleeding around the catheter	first day postoperative
number of patients with penile extravasation	penile swelling from fluid extravasation	first day postoperative
number of patients with urinary tract infection	urinary tract infection from urine analysis and culture	first month postoperative
number of patients with urethral stricture recurrence	recurrence of symptoms with urine outflow obstruction and difficult voiding as measured by uroflow	from catheter removal up to 1 year postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: R55/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No