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

NCT04650347 | Completed Phase 2 DMC

• 1 other identifier: R55/2017
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Urethral Stricture, Male

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• operation time in minutes

  intraoperative finding

• number of patients with bleeding per urethra

  first day postoperative

• number of patients with penile extravasation

  first day postoperative

• number of patients with urinary tract infection

  first month postoperative

• number of patients with urethral stricture recurrence

  from catheter removal up to 1 year postoperative

Study Arms (2)

internal urethrotomy using Holmium laser representing group

EXPERIMENTAL

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

internal urethrotomy with Sachs cold knife

ACTIVE COMPARATOR

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

Interventions

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.

internal urethrotomy using Holmium laser representing group; internal urethrotomy with Sachs cold knife

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: surgical intervention of male urethra stricture
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Urology department - ain shams university

Cairo, 11361, Egypt

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: patients, data collector, and the statistician were blinded to the type of intervention. the assessment was done to group A and B
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: the investigators planned to conduct a controlled trial with randomization in which eighty participants will be included with symptoms of outflow obstruction secondary to urethral stricture. this is between March 2017 and December 2019. those patients attended the outpatient clinic of our tertiary hospital of Ain Shams University. patients were allocated into 2 equal groups randomly. each group involved 40 patients. Group 1 will represent the holmium laser internal urethrotomy group while group 2 will represent the cold knife internal urethrotomy group.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

EG (1)