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Renal StoneNCT05725226

Comparison Between 6Fr Vs 4Fr Double J Stent

A study testing Double J Stent 6Fr x 26cms and Double J Stent 4Fr x26cms in people with Renal Stone and Ureter Stone, run by Tribhuvan University, Nepal at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Stone, Ureter Stone
What is being tested?
Double J Stent 6Fr x 26cms and Double J Stent 4Fr x26cms
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteNepal
Study dates
7 Apr 2023to 21 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Nepal1 site
  • Tribhuvan University Teaching Hospital (TUTH), Institute of Medicine

    Kathmandu, Bagmati, 977

Other trials in Nepal

About this study

Official title: Comparison Between Standard Vs Small Sized Double J Stent On Urological Symptoms Following RIRS And URSL: A Prospective Randomized Controlled Trial

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.

Read the 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.

Being tested
Double J Stent 6Fr x 26cms, Double J Stent 4Fr x26cms
Medical subject headings
Nephrolithiasis, Ureterolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double J Stent 6Fr x 26cmsDevice

    Surgery will be performed by expert Urologist.

  • Double J Stent 4Fr x26cmsDevice

    Surgery will be performed by expert Urologist.

Study groups in NCT05725226
Study groupRoleWhat they receive
Group 1 : 6FrActive comparatorProcedure: RIRs/URSL Confirmation of Renal/ Ureteric Stone with CT Urography Preanesthetic Check up and SterileUrine Culture obtained prior to surgery Perioperative Care: Inj. Ceftriaxone 1gm IV stat dose , RIRS/ URSL performed using LASER Holmium lithotripsy 6Fr Double J stent is inserted to maintain the ureteric patency USSQ score obtained on Post operative Day 3, Day 7 and on the day of stone removal (Day 14) USG Abdomen and Pelvis is done on post operative Day 30 to confirm stone clearance.
Receives: Device: Double J Stent 6Fr x 26cms
Group 2: 4FrExperimentalProcedure: RIRs/URSL Confirmation of Renal/ Ureteric Stone with CT Urography Preanesthetic Check up and SterileUrine Culture obtained prior to surgery Perioperative Care: Inj. Ceftriaxone 1gm IV stat dose , RIRS/ URSL performed using LASER Holmium lithotripsy 4Fr Double J stent is inserted to maintain the ureteric patency USSQ score obtained on Post operative Day 3, Day 7 and on the day of stone removal (Day 14) USG Abdomen and Pelvis is done on post operative Day 30 to confirm stone clearance.
Receives: Device: Double J Stent 4Fr x26cms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare Ureteral Stent Symptom Questionnaire (USSQ) scores following 6Fr vs 4Fr Double J stenting

    Ureteral Stent Symptom Questionnaire score will be obtained by requesting the participants to fill the questionnaire. The questionnaire will be filled on post operative Day 3, Day 7 and Day 14. The maximum possible score is 169 and minimum score is 33. Higher score indicates poor performance of Double J stent.

    Measured: 14 days

Secondary outcomes (3)
  1. To analyze the demographic pattern of patients undergoing URSL and RIRS in TUTH

    All demographic data are entered prior to surgery.

    Measured: 1day, on the date of admission

  2. To compare the pain score, urinary symptoms, general health, sexual symptoms and work performance following 6Fr and 4Fr Double J Stenting

    Ureteral Stent Symptom Questionnaire score is the sum of the scores of pain symptoms, urinary symptoms, general health symptoms, work performance symptoms and sexual symptoms. All these components will also be analyzed separately.

    Measured: 14 days

  3. To compare stone clearance following 6Fr and 4Fr Double J stenting

    Stone Clearance will be confirmed by ultrasonography done post operatively on Day 30.

    Measured: Post operative day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2023
  2. Study start7 Apr 2023
  3. Primary completion21 Dec 2023
  4. Study completion21 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05725226
Sponsor's protocol ID
PKhatiwada
Status last verified
May 2024
First submitted
13 Jan 2023
Last updated
21 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Double J Stent 6Fr x 26cms and Double J Stent 4Fr x26cms in people with Renal Stone and Ureter Stone, run by Tribhuvan University, Nepal at 1 site in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare Ureteral Stent Symptom Questionnaire (USSQ) scores following 6Fr vs 4Fr Double J stenting (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.

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