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Completed

NCT Number: NCT04650347

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

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

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Key information

Conditions

Urethral Stricture, Male Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urethral Obstruction Urethral Stricture Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Urology department - ain shams university

Cairo, 11361, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

visualized internal urethrotomy

Procedure

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.

Primary outcomes

  1. Maximum flow rate (ml/sec.)

    Time frame: at 3 months

    maximum flow rate, uroflow finding (ml/sec.)

  2. Maximum flow rate(ml/sec.)

    Time frame: at 12 months

    maximum flow rate, uroflow finding (ml/sec.)

Secondary outcomes

  1. operation time in minutes

    Time frame: intraoperative finding

    time of operation from cystoscopy till catheter insertion

  2. number of patients with bleeding per urethra

    Time frame: first day postoperative

    postoperative bleeding around the catheter

  3. number of patients with penile extravasation

    Time frame: first day postoperative

    penile swelling from fluid extravasation

  4. number of patients with urinary tract infection

    Time frame: first month postoperative

    urinary tract infection from urine analysis and culture

  5. number of patients with urethral stricture recurrence

    Time frame: from catheter removal up to 1 year postoperative

    recurrence of symptoms with urine outflow obstruction and difficult voiding as measured by uroflow

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 2, 2020
Registry last updated
Mar 2, 2021

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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