Clinical trial NCT04650347: Holmium: YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures
Official title: Holmium: YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urethral Stricture, Male
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum flow rate (ml/sec.)
timeFrame: at 3 months
measure: Maximum flow rate(ml/sec.)
timeFrame: at 12 months
Secondary outcomes:
measure: operation time in minutes
timeFrame: intraoperative finding
measure: number of patients with bleeding per urethra
timeFrame: first day postoperative
measure: number of patients with penile extravasation
timeFrame: first day postoperative
measure: number of patients with urinary tract infection
timeFrame: first month postoperative
measure: number of patients with urethral stricture recurrence
timeFrame: from catheter removal up to 1 year postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urology department - ain shams university
Study officials:
References: