Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05725226 |
| Other study ID # |
PKhatiwada |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 7, 2023 |
| Est. completion date |
December 21, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
Tribhuvan University, Nepal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
