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

Urethral Stricture, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650347
• Other study ID #: R55/2017
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: February 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture
• Urethral Stricture, Male

Intervention

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.

Locations

Country	Name	City	State
Egypt	Urology department - ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum flow rate (ml/sec.)	maximum flow rate, uroflow finding (ml/sec.)	at 3 months
Primary	Maximum flow rate(ml/sec.)	maximum flow rate, uroflow finding (ml/sec.)	at 12 months
Secondary	operation time in minutes	time of operation from cystoscopy till catheter insertion	intraoperative finding
Secondary	number of patients with bleeding per urethra	postoperative bleeding around the catheter	first day postoperative
Secondary	number of patients with penile extravasation	penile swelling from fluid extravasation	first day postoperative
Secondary	number of patients with urinary tract infection	urinary tract infection from urine analysis and culture	first month postoperative
Secondary	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