Clinical trial NCT05725226: Comparison Between 6Fr Vs 4Fr Double J Stent
Official title: Comparison Between Standard Vs Small Sized Double J Stent On Urological Symptoms Following RIRS And URSL: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Ureter Stone
Lead sponsor: Tribhuvan University, Nepal
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to study where two groups of treatments, Group 1 (6 Fr) and Group 2 (4Fr), are given so that Group 1 will receive 6Fr Double J stent after endourological stone fragmentation and Group 2 will receive 4Fr Double J stent after endourological stone fragmentation.
Primary purpose: TREATMENT

Brief summary: Double J (DJ) Stenting is a commonly done procedure in endourology to ensure ureteric patency following Urological Interventions. DJ stents are available in various sizes. This study is focused on comparing two different sizes of DJ Stents, one standard sized 6Fr and other small sized 4Fr. DJ stents are uncomfortable to the patients and few studies have indicated that small size of stents are might be less troublesome. Through this study we plan to establish a relation between different symptoms and size of DJ stents. Study will be conducted at Tribhuvan University Teaching Hospital (TUTH),Maharajgunj.All adults with sterile urine culture prior to stenting will be taken into consideration. Informed consent will be taken and two randomized groups of 6Fr and 4Fr will be formed and data entry done in MS Excel and analysis done by SPSS. The study is expected to take duration of 12months. Ureteral Stent Symptom Questionnaire (USSQ) will evaluate the symptoms on third day and seventh day of stent placement and on Day of stent removal. We expect 4Fr stent to be superior to 6Fr for reduction of stent related symptoms.

Detailed description: The concept of the endoscopic access to the renal collecting systems for the diagnosis and treatment of upper urinary tract diseases was firstly introduced by V. Marshall who first described in 1964 the navigation in the renal pelvis with a rudimental flexible fiberscope. Retrograde intrarenal surgery (RIRS) by means of flexible ureterorenoscopes (fURSs) is considered one of the first-line treatment options for the active removal of renal stones. Ureteroscopic Lithotripsy (URSL) with the holmium laser is an effective and safe method for treating ureterolithiasis. After RIRS, one of the technical aspect is the placement of a double-J stent. The underlying rationale of ureteric stent is to allow the urinary flow to bypass internal or external obstructions, which impair its drainage. 'Double-J' refers to the most common type of stent design that was initially introduced by Finney in 1978. The term 'double-J' refers to the 'J' shape of each end of the stent, which is designed to anchor the stent and prevent its displacement. The mean size of normal ureter is 1.8mm with a standard deviation of 0.9 mm. The standard size for double J stents is typically 6 Fr. Few studies have been done comparing standard 6Fr and smaller sized DJ stent. One study published in March 2018 has shown 4Fr stent superior to 5Fr and 6Fr stent. A Randomised Control Trial (RCT) published in July 2018 has shown 4.8 Fr stent superior to 6Fr stent. To assess ureteral stent-related symptoms, Joshi et al. described and validated the Ureteral Stent Related Symptom Questionnaire (USSQ) in 2003. This self-administered questionnaire includes questions in six sections: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. The total score is the sum of all questions. This questionnaire can define and compare stent-related symptoms.

DJ stent cause significant side effects. Dysuria, urinary frequency and urgency were reported by 40%, 50% and 55% of the patients, respectively. Flank pain, gross hematuria and fever was reported by 32%, 42% and 15% respectively. Anxiety and sleep disturbance were reported by 24% and 20% respectively, and 45% of patients reported impairment in their quality of life. Decreased libido was reported by 45%, and sexual dysfunction by 42% of men and 86% of women. With few studies showing small sized DJ stent causing less symptoms that standard 6Fr stents; our study aims to ascertain whether the previous studies were in line to change the standard size of DJ stent from 6Fr to smaller size, possibly 4Fr. 6Fr DJ stent is commonly used in our center. This study is aimed to compare standard size of DJ stent with small size in TUTH.

All cases of urinary tract stones requiring endourologic intervention will be sampled for study and cases meeting the inclusion criteria will be randomized via simple random sampling and computer generated numbers enclosed in a sealed envelope opened just prior to surgery, into two groups: Group A 6Fr and Group B 4Fr. All cases will receive a single dose of ceftriaxone intraoperatively. RIRS will be done using Ureteral Access Sheath (UAS) 9.5-11.5 Fr. DJ Stent 4Fr or 6Fr will be used and length of DJ Stent will be 26cm. Stent will be removed on the 14th postoperative day. Symptoms will be assessed on day 3, day 7 and on the day of stent removal. Stone Clearance will be assured after 1 month with ultrasonography of abdomen.

Eligibility criteria: Inclusion Criteria:

* Age\> 18yrs
* Informed Consent
* Sterile Urine culture prior to surgery

Exclusion Criteria:

* Bilateral DJ stenting
* Pregnancy
* Ureteral Strictures
* Complicated Surgery: Trauma, Bleeding

Primary outcomes:
measure: To compare Ureteral Stent Symptom Questionnaire (USSQ) scores following 6Fr vs 4Fr Double J stenting
timeFrame: 14 days
Secondary outcomes:
measure: To analyze the demographic pattern of patients undergoing URSL and RIRS in TUTH
timeFrame: 1day, on the date of admission
measure: To compare the pain score, urinary symptoms, general health, sexual symptoms and work performance following 6Fr and 4Fr Double J Stenting
timeFrame: 14 days
measure: To compare stone clearance following 6Fr and 4Fr Double J stenting
timeFrame: Post operative day 30
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan University Teaching Hospital (TUTH), Institute of Medicine
state: Bagmati
Study officials:
affiliation: Head of Department, Department of Urology and Kidney Transplant Surgery, TUTH
name: Pawan Rj Chalise, MCh Urology
role: STUDY_CHAIR
References: