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

NCT ID: NCT04650347

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-03-01

Brief Summary

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

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.

Conditions

Urethral Stricture, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

visualized internal urethrotomy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

visualized internal urethrotomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maher Gamil Ahmed Higazy

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Urology department - ain shams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

R55/2017

Identifier Type: -

Identifier Source: org_study_id