Ureteric StoneNCT04851171
Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone
A study testing Flexible Ureteroscopy and Semi-rigid Ureteroscopy in people with Ureteric Stone and Stone Ureter, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The present study is randomized in nature, comparing the stone free rate and complications rate between semi-rigid ureteroscopy (SR-URS) and Flexible Ureteroscopy (F-URS) for the treatment of Proximal Ureteric stone (PUS), whereby the preoperative assessments, procedure and reporting of outcomes will all be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteric Stone, Stone Ureter
- What is being tested?
- Flexible Ureteroscopy and Semi-rigid Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteQatar
- Study dates
- 26 Nov 2020to Jan 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 ≥ 18 years
- Single proximal ureteric stone indicated for active treatment with ureteroscopy (stented or non-stented)
Who cannot join
- Solitary Kidney
- Bilateral ureteric stones
- Ipsilateral multiple simultaneous ureteric stones
- Ipsilateral kidney stone
- Active UTI
- Coagulopathy diseases
Show all 10Show fewer
- Ipsilateral ureteral anomalies, ureteral disorder (tumor or stricture) or previous ureteral open surgery.
- Pregnant patients.
- Unable to give informed consent.
- Patient is not agreeing to go through the randomization.
Trial locations and contacts
1 site in 1 country.
Ibrahim Alnadhari, MD, FRCS Uro contact
Qatar1 site, 1 recruiting
- Recruiting
Al Wakra Hospital
Al-Wakrah, Baladiyat ad Dawhah, 0000
Ibrahim Alnadhari, MD, FRCS Uro
About this study
Official title: A Randomized Controlled Trial Comparing Semi-rigid Ureteroscopy and Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone
The present study is randomized in nature, comparing the stone free rate and complications rate between semi-rigid ureteroscopy (SR-URS) and Flexible Ureteroscopy (F-URS) for the treatment of Proximal Ureteric stone (PUS), whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.
Read the detailed description
There are various treatment options that can be used for the treatment of PUS, which include extracorporeal shockwave lithotripsy (SWL), ureteroscopy (URS), percutaneous nephrolithotomy (PCNL), antegrade uretero-lithotripsy, laparoscopy, and rarely, open surgical procedures. However, the standard, and the most frequently used modalities are SWL and ureteroscopy. When comparing the effectiveness in the treatment of Proximal Ureteric stone (PUS) between SWL and URS, SWL has lower rates of complication and morbidity, but URS has a higher likelihood of successfully treating the patient within a single procedure. Additionally, with the advancements in technology and miniaturization of the ureteroscopes, along with the presence of auxiliary instruments such as holmium laser and retrieval baskets, ureteroscopy is more widely used.
In the proximal ureter, SR-URS tends to encounter difficulties in accessing the stone, but F-URS aids in overcoming those difficulties. As a result, the use of F-URS for PUS has indicated a strong success rate with lower likelihood of complications. When comparing the drawbacks of the two types of modalities, F-URS tends to be more expensive, and requires auxiliary instruments. And SR-URS tends to have lower success rate along with an increased rate in complications.
The precedence of FURS over SR-URS in the treatment of PUS is yet to be extensively studied. Presently there are only five studies that have compared the two modalities of treatment. But, due to the lack standardization of variables, procedure, follow-up imaging and reporting of outcomes in the past studies, it is imperative to conduct study that is prospective and randomized in nature.
The present study is randomized in nature, comparing the stone free rate and complications rate between SR-URS and F-URS for the treatment of PUS, whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.
- Conditions
- Ureteric Stone, Stone Ureter
- Being tested
- Flexible Ureteroscopy, Semi-rigid Ureteroscopy
- Keywords
- Urolithiasis, Ureteroscopy, Ureteric stone, Flexible ureteroscopy, Semi-rigid ureteroscopy
- Medical subject headings
- Ureterolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible UreteroscopyProcedure or surgery
Flexible ureteroscopy is the use of flexible ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.
Semi-rigid UreteroscopyProcedure or surgery
Semi-rigid ureteroscopy is the use of the semi-rigid ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.
| Study group | Role | What they receive |
|---|---|---|
| Semi-rigid Ureteroscopy | Active comparator | Patient with upper ureteric stone who are randomized in this arm will undergo semi-rigid ureteroscopy for treatment of the stone. Receives: Procedure: Semi-rigid Ureteroscopy |
| Flexible Ureteroscopy | Active comparator | Patient with upper ureteric stone who are randomized in this arm will undergo flexible ureteroscopy for treatment of the stone. Receives: Procedure: Flexible Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Sone free status will be assessed by doing CT KUB scan 4 weeks postoperative and it is defined as patients with no residual stones or clinically insignificant residual fragments (< 2 mm).
Measured: Four weeks
Secondary outcomes (2)
Complication rate
To evaluate the complication rate post procedure including infection rate, genitourinary injury, hematuria, emergency visits rate and we will use of modified Calvin Dindo classification to grade the surgical complications.
Measured: Three Months
To compare stone free rate and complications between patients with ureteric stent and patients without ureteric stent
Patients will be stratified into two groups: group 1 with ureteric stents and group 2 without ureteric stents. Then comparison between the two groups in regards the stone free rate and the complications rate as per the previous definitions.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start26 Nov 2020
- Primary completionNov 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ureteric StoneStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Ibrahim Alnadhari, Hamad Medical Corporation
- Investigators
- Ibrahim Al-Nadhari, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851171
- Sponsor's protocol ID
- MRC-01-19-036
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolf JS Jr. Treatment selection and outcomes: ureteral calculi. Urol Clin North Am. 2007 Aug;34(3):421-30. doi: 10.1016/j.ucl.2007.04.010.
PubMed 17678991Lee JH, Woo SH, Kim ET, Kim DK, Park J. Comparison of Patient Satisfaction with Treatment Outcomes between Ureteroscopy and Shock Wave Lithotripsy for Proximal Ureteral Stones. Korean J Urol. 2010 Nov;51(11):788-93. doi: 10.4111/kju.2010.51.11.788. Epub 2010 Nov 17.
PubMed 21165201Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27.
PubMed 27238615Hyams ES, Monga M, Pearle MS, Antonelli JA, Semins MJ, Assimos DG, Lingeman JE, Pais VM Jr, Preminger GM, Lipkin ME, Eisner BH, Shah O, Sur RL, Mufarrij PW, Matlaga BR. A prospective, multi-institutional study of flexible ureteroscopy for proximal ureteral stones smaller than 2 cm. J Urol. 2015 Jan;193(1):165-9. doi: 10.1016/j.juro.2014.07.002. Epub 2014 Jul 9.
PubMed 25014576Alkan E, Saribacak A, Ozkanli AO, Basar MM, Acar O, Balbay MD. Flexible Ureteroscopy Can Be More Efficacious in the Treatment of Proximal Ureteral Stones in Select Patients. Adv Urol. 2015;2015:416031. doi: 10.1155/2015/416031. Epub 2015 Nov 4.
PubMed 26617636Galal EM, Anwar AZ, El-Bab TK, Abdelhamid AM. Retrospective comparative study of rigid and flexible ureteroscopy for treatment of proximal ureteral stones. Int Braz J Urol. 2016 Sep-Oct;42(5):967-972. doi: 10.1590/S1677-5538.IBJU.2015.0644.
PubMed 27622276Karadag MA, Demir A, Cecen K, Bagcioglu M, Kocaaslan R, Altunrende F. Flexible ureterorenoscopy versus semirigid ureteroscopy for the treatment of proximal ureteral stones: a retrospective comparative analysis of 124 patients. Urol J. 2014 Nov 1;11(5):1867-72.
PubMed 25361706
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Semi-rigid Ureteroscopy and Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone
- ClinicalTrials.gov ID
- NCT04851171
- Acronym / sponsor ID
- MRC-01-19-036
- Conditions
- Ureteric Stone, Stone Ureter
- Keywords
- Urolithiasis, Ureteroscopy, Ureteric stone, Flexible ureteroscopy, Semi-rigid ureteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 20 Apr 2021 (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.
The present study is randomized in nature, comparing the stone free rate and complications rate between semi-rigid ureteroscopy (SR-URS) and Flexible Ureteroscopy (F-URS) for the treatment of Proximal Ureteric stone (PUS), whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.
Detailed description
There are various treatment options that can be used for the treatment of PUS, which include extracorporeal shockwave lithotripsy (SWL), ureteroscopy (URS), percutaneous nephrolithotomy (PCNL), antegrade uretero-lithotripsy, laparoscopy, and rarely, open surgical procedures. However, the standard, and the most frequently used modalities are SWL and ureteroscopy. When comparing the effectiveness in the treatment of Proximal Ureteric stone (PUS) between SWL and URS, SWL has lower rates of complication and morbidity, but URS has a higher likelihood of successfully treating the patient within a single procedure. Additionally, with the advancements in technology and miniaturization of the ureteroscopes, along with the presence of auxiliary instruments such as holmium laser and retrieval baskets, ureteroscopy is more widely used.
In the proximal ureter, SR-URS tends to encounter difficulties in accessing the stone, but F-URS aids in overcoming those difficulties. As a result, the use of F-URS for PUS has indicated a strong success rate with lower likelihood of complications. When comparing the drawbacks of the two types of modalities, F-URS tends to be more expensive, and requires auxiliary instruments. And SR-URS tends to have lower success rate along with an increased rate in complications.
The precedence of FURS over SR-URS in the treatment of PUS is yet to be extensively studied. Presently there are only five studies that have compared the two modalities of treatment. But, due to the lack standardization of variables, procedure, follow-up imaging and reporting of outcomes in the past studies, it is imperative to conduct study that is prospective and randomized in nature.
The present study is randomized in nature, comparing the stone free rate and complications rate between SR-URS and F-URS for the treatment of PUS, whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semi-rigid Ureteroscopy | Active comparator | Procedure: Semi-rigid UreteroscopyPatient with upper ureteric stone who are randomized in this arm will undergo semi-rigid ureteroscopy for treatment of the stone. |
| Flexible Ureteroscopy | Active comparator | Procedure: Flexible UreteroscopyPatient with upper ureteric stone who are randomized in this arm will undergo flexible ureteroscopy for treatment of the stone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Single proximal ureteric stone indicated for active treatment with ureteroscopy (stented or non-stented)
Key exclusion criteria (10 listed)
- Solitary Kidney
- Bilateral ureteric stones
- Ipsilateral multiple simultaneous ureteric stones
- Ipsilateral kidney stone
- Active UTI
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 |
|---|---|---|
| Flexible UreteroscopyFlexible ureteroscopy is the use of flexible ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy. | Procedure or surgery | Flexible Ureteroscopy |
| Semi-rigid UreteroscopySemi-rigid ureteroscopy is the use of the semi-rigid ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy. | Procedure or surgery | Semi-rigid Ureteroscopy |
Primary outcome
Stone free rate
Time frame: Four weeks
Sone free status will be assessed by doing CT KUB scan 4 weeks postoperative and it is defined as patients with no residual stones or clinically insignificant residual fragments (< 2 mm).
2 secondary outcomes
Complication rate
Time frame: Three Months
To compare stone free rate and complications between patients with ureteric stent and patients without ureteric stent
Time frame: Three Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Background: PubMed 17678991Wolf JS Jr. Treatment selection and outcomes: ureteral calculi. Urol Clin North Am. 2007 Aug;34(3):421-30. doi: 10.1016/j.ucl.2007.04.010.
- Background: PubMed 21165201Lee JH, Woo SH, Kim ET, Kim DK, Park J. Comparison of Patient Satisfaction with Treatment Outcomes between Ureteroscopy and Shock Wave Lithotripsy for Proximal Ureteral Stones. Korean J Urol. 2010 Nov;51(11):788-93. doi: 10.4111/kju.2010.51.11.788. Epub 2010 Nov 17.
- Background: PubMed 27238615Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27.
- Background: PubMed 25014576Hyams ES, Monga M, Pearle MS, Antonelli JA, Semins MJ, Assimos DG, Lingeman JE, Pais VM Jr, Preminger GM, Lipkin ME, Eisner BH, Shah O, Sur RL, Mufarrij PW, Matlaga BR. A prospective, multi-institutional study of flexible ureteroscopy for proximal ureteral stones smaller than 2 cm. J Urol. 2015 Jan;193(1):165-9. doi: 10.1016/j.juro.2014.07.002. Epub 2014 Jul 9.
- Background: PubMed 26617636Alkan E, Saribacak A, Ozkanli AO, Basar MM, Acar O, Balbay MD. Flexible Ureteroscopy Can Be More Efficacious in the Treatment of Proximal Ureteral Stones in Select Patients. Adv Urol. 2015;2015:416031. doi: 10.1155/2015/416031. Epub 2015 Nov 4.
- Background: PubMed 27622276Galal EM, Anwar AZ, El-Bab TK, Abdelhamid AM. Retrospective comparative study of rigid and flexible ureteroscopy for treatment of proximal ureteral stones. Int Braz J Urol. 2016 Sep-Oct;42(5):967-972. doi: 10.1590/S1677-5538.IBJU.2015.0644.
- Background: PubMed 25361706Karadag MA, Demir A, Cecen K, Bagcioglu M, Kocaaslan R, Altunrende F. Flexible ureterorenoscopy versus semirigid ureteroscopy for the treatment of proximal ureteral stones: a retrospective comparative analysis of 124 patients. Urol J. 2014 Nov 1;11(5):1867-72.
- Türk C, Neisius A, Petřík A, Seitz C, Skolarikos A, Thomas K. EAU Guidelines on UrolithiasisLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Ureteric Stone
Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
Not yet recruiting
DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones
Kidney Stones, Nephrolithiasis
Active, not recruiting
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
Kidney Calculi, Kidney Diseases
Recruiting
Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)
Urolithiasis, Kidney Calculi
RecruitingPhase 4
Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
Ureteral Calculi
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.
Ibrahim Alnadhari, MD, FRCS Uro contact
Ibrahim Al-Nadhari principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible Ureteroscopy and Semi-rigid Ureteroscopy in people with Ureteric Stone and Stone Ureter, run by Hamad Medical Corporation at 1 site in Qatar.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Apr 2021. 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 Qatar. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Alnadhari, MD, FRCS Uro (+974-33403324/ +974-40115093, ibrahimah1978@yahoo.com, IAlnadhari@hamad.qa,), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851171, which also lists 7 linked publications.
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 20 Apr 2021.