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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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
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.
- Conditions
- Renal Stone, Ureter Stone
- 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 group | Role | What they receive |
|---|---|---|
| Group 1 : 6Fr | Active comparator | Procedure: 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: 4Fr | Experimental | Procedure: 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.
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)
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
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
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.
- First posted13 Feb 2023
- Study start7 Apr 2023
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prajwal Khatiwada, Tribhuvan University, Nepal
- Investigators
- Pawan Rj Chalise, MCh Urology, Study chair, Head of Department, Department of Urology and Kidney Transplant Surgery, TUTH
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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Standard Vs Small Sized Double J Stent On Urological Symptoms Following RIRS And URSL: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05725226
- Acronym / sponsor ID
- PKhatiwada
- Conditions
- Renal Stone, Ureter Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tribhuvan University, NepalUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 : 6Fr | Active comparator | Device: Double J Stent 6Fr x 26cmsProcedure: 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. |
| Group 2: 4Fr | Experimental | Device: Double J Stent 4Fr x26cmsProcedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age> 18yrs
- Informed Consent
- Sterile Urine culture prior to surgery
Key exclusion criteria (4 listed)
- Bilateral DJ stenting
- Pregnancy
- Ureteral Strictures
- Complicated Surgery: Trauma, Bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double J Stent 6Fr x 26cmsSurgery will be performed by expert Urologist. | Device | Group 1 : 6Fr |
| Double J Stent 4Fr x26cmsSurgery will be performed by expert Urologist. | Device | Group 2: 4Fr |
Primary outcome
To compare Ureteral Stent Symptom Questionnaire (USSQ) scores following 6Fr vs 4Fr Double J stenting
Time frame: 14 days
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.
3 secondary outcomes
To analyze the demographic pattern of patients undergoing URSL and RIRS in TUTH
Time frame: 1day, on the date of admission
To compare the pain score, urinary symptoms, general health, sexual symptoms and work performance following 6Fr and 4Fr Double J Stenting
Time frame: 14 days
To compare stone clearance following 6Fr and 4Fr Double J stenting
Time frame: Post operative day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pawan Rj Chalise, MCh Urology study chair
Head of Department, Department of Urology and Kidney Transplant Surgery, TUTH
1 site in 1 country: see every site and its status.
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.