Flexible UreteroscopyNCT05857501
Preoperative Prediction of Flexible Ureteroscopy Outcome in the Treatment of Renal Calculi
An observational study of Flexible Ureteroscopy, run by Menoufia University.
Trial summary
To predict the outcome of flexible ureteroscopy in the management of renal stones based on preoperative scoring module using five preoperative parameters that have effect on stone free status postoperatively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Flexible Ureteroscopy
- What is being tested?
- abdominopelvic computerized tomography (CT) without contrast
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2023to Apr 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with renal stones that are < 2 cm in maximal diameter will be recruited to the study. Patients will be counseled for flexible ureteroscopy, and the procedure will be explained to them with discussion about its pros and cons. Patients agreeable to enrollment will sign an informed written consent after fulfillment of ethical approval forms.Stone free rate will be assessed at one week, one month, and three months post-operatively using Plain X-ray for radio-opaque stones and NCCT for radiolucent stones. Stone free rate will be determined by no stone fragment > 4mm. Number of ancillary procedures required to reach SF will be reported
Who may be able to join
- Renal stones (≤ 2 cm)
- Radiolucent stone resistant to SWL and oral chemical dissolution treatment (≤2cm)
Who cannot join
- Large stones (> 2 cm).
- Staghorn stone (stone involving the renal pelvis and more than two calyces).
- Patient preference of other treatment modality
Trial locations and contacts
No sites are listed yet.
About this study
To predict the outcome of flexible ureteroscopy in the management of renal stones based on preoperative scoring module using five preoperative parameters that have effect on stone free status postoperatively.
Read the detailed description
Although flexible ureteroscopy has been in use for decades, neither the European Association of Urology (EAU) nor the American Urological association (AUA), in their clinical guidelines, recommends flexible ureteroscopy (FURS) as a first-line procedural treatment for renal stones . Several reports showed that FURS is a suitable alternative to shockwave lithotripsy (SWL) and percutaneous nephrolithotripsy (PCNL) for the treatment of renal stones, with potentially higher stone-free rates than SWL and lower morbidity than PCNL.
Safe and effective removal by FURS of multiple and large intrarenal stones, including lower pole calculi, has been documented suggesting that FURS is effective for complex intrarenal stone removal . With the multitude of available procedures, selection of the optimal one for management of renal stone is becoming more challenging.
Established models for predicting the outcomes of SWL and PCNL exist . However, a predictive model for predicting the outcome of URS is still in development , particularly for FURS treatment of renal stones. Four scores have been developed for FURS. Two of these have been compared and validated in different cohorts: the Resolu Unsal Stone Score (RUSS) and modified Seoul National University Renal Stone Complexity (S-ReSC) score , the other two scores, the S.T.O.N.E score described by Molina et al. and Ito's nomogram.
Many studies have demonstrated that stone volume is the most significant factor predictive of stone-free status (SF) after FURS. The investigators speculate that stone volume combined with other variables might improve prediction of SF after FURS. The aim of the present study is to evaluate various preoperative parameters as predictors of FURS outcome based on the Ito's nomogram
- Conditions
- Flexible Ureteroscopy
- Being tested
- abdominopelvic computerized tomography (CT) without contrast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominopelvic computerized tomography (CT) without contrastDevice
Also called digital KUB (plain x-ray on urology system )
scan combines a series of X-ray images taken from different angles around your body and uses computer processing to create cross-sectional images (slices) of the bones, blood vessels and soft tissues inside your body. CT scan images provide more-detailed information than plain X-rays do.
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate after flexible ureteroscopy
the investigators predict the outcome of flexible ureteroscopy in the management of renal stones based on preoperative scoring module using five preoperative parameters that have effect on stone free rate postoperatively.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start10 May 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Flexible UreteroscopyStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, islam mohamed abou bakr mansour, Menoufia University
- Investigators
- Mohamed Abdelgaber Selim, ASS-PROF, Principal investigator, menofia universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857501
- Sponsor's protocol ID
- FURS outcome prediciton
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Preminger GM, Tiselius HG, Assimos DG, Alken P, Buck C, Gallucci M, Knoll T, Lingeman JE, Nakada SY, Pearle MS, Sarica K, Turk C, Wolf JS Jr; EAU/AUA Nephrolithiasis Guideline Panel. 2007 guideline for the management of ureteral calculi. J Urol. 2007 Dec;178(6):2418-34. doi: 10.1016/j.juro.2007.09.107. No abstract available.
PubMed 17993340Tiselius HG, Ackermann D, Alken P, Buck C, Conort P, Gallucci M; Working Party on Lithiasis, European Association of Urology. Guidelines on urolithiasis. Eur Urol. 2001 Oct;40(4):362-71. doi: 10.1159/000049803.
PubMed 11713390El-Nahas AR, Ibrahim HM, Youssef RF, Sheir KZ. Flexible ureterorenoscopy versus extracorporeal shock wave lithotripsy for treatment of lower pole stones of 10-20 mm. BJU Int. 2012 Sep;110(6):898-902. doi: 10.1111/j.1464-410X.2012.10961.x. Epub 2012 Feb 28.
PubMed 22372915Cohen J, Cohen S, Grasso M. Ureteropyeloscopic treatment of large, complex intrarenal and proximal ureteral calculi. BJU Int. 2013 Mar;111(3 Pt B):E127-31. doi: 10.1111/j.1464-410X.2012.11352.x. Epub 2012 Jul 3.
PubMed 22757752Pearle MS, Lingeman JE, Leveillee R, Kuo R, Preminger GM, Nadler RB, Macaluso J, Monga M, Kumar U, Dushinski J, Albala DM, Wolf JS Jr, Assimos D, Fabrizio M, Munch LC, Nakada SY, Auge B, Honey J, Ogan K, Pattaras J, McDougall EM, Averch TD, Turk T, Pietrow P, Watkins S. Prospective randomized trial comparing shock wave lithotripsy and ureteroscopy for lower pole caliceal calculi 1 cm or less. J Urol. 2008 May;179(5 Suppl):S69-73. doi: 10.1016/j.juro.2008.03.140.
PubMed 18405758Akman T, Binbay M, Ozgor F, Ugurlu M, Tekinarslan E, Kezer C, Aslan R, Muslumanoglu AY. Comparison of percutaneous nephrolithotomy and retrograde flexible nephrolithotripsy for the management of 2-4 cm stones: a matched-pair analysis. BJU Int. 2012 May;109(9):1384-9. doi: 10.1111/j.1464-410X.2011.10691.x. Epub 2011 Oct 28.
PubMed 22093679Breda A, Ogunyemi O, Leppert JT, Schulam PG. Flexible ureteroscopy and laser lithotripsy for multiple unilateral intrarenal stones. Eur Urol. 2009 May;55(5):1190-6. doi: 10.1016/j.eururo.2008.06.019. Epub 2008 Jun 13.
PubMed 18571315Breda A, Ogunyemi O, Leppert JT, Lam JS, Schulam PG. Flexible ureteroscopy and laser lithotripsy for single intrarenal stones 2 cm or greater--is this the new frontier? J Urol. 2008 Mar;179(3):981-4. doi: 10.1016/j.juro.2007.10.083. Epub 2008 Jan 22.
PubMed 18207179Takazawa R, Kitayama S, Tsujii T. Successful outcome of flexible ureteroscopy with holmium laser lithotripsy for renal stones 2 cm or greater. Int J Urol. 2012 Mar;19(3):264-7. doi: 10.1111/j.1442-2042.2011.02931.x. Epub 2011 Dec 6.
PubMed 22145599Wiesenthal JD, Ghiculete D, Ray AA, Honey RJ, Pace KT. A clinical nomogram to predict the successful shock wave lithotripsy of renal and ureteral calculi. J Urol. 2011 Aug;186(2):556-62. doi: 10.1016/j.juro.2011.03.109.
PubMed 21684557Kanao K, Nakashima J, Nakagawa K, Asakura H, Miyajima A, Oya M, Ohigashi T, Murai M. Preoperative nomograms for predicting stone-free rate after extracorporeal shock wave lithotripsy. J Urol. 2006 Oct;176(4 Pt 1):1453-6; discussion 1456-7. doi: 10.1016/j.juro.2006.06.089.
PubMed 16952658Smith A, Averch TD, Shahrour K, Opondo D, Daels FP, Labate G, Turna B, de la Rosette JJ; CROES PCNL Study Group. A nephrolithometric nomogram to predict treatment success of percutaneous nephrolithotomy. J Urol. 2013 Jul;190(1):149-56. doi: 10.1016/j.juro.2013.01.047. Epub 2013 Jan 23.
PubMed 23353048Imamura Y, Kawamura K, Sazuka T, Sakamoto S, Imamoto T, Nihei N, Suzuki H, Okano T, Nozumi K, Ichikawa T. Development of a nomogram for predicting the stone-free rate after transurethral ureterolithotripsy using semi-rigid ureteroscope. Int J Urol. 2013 Jun;20(6):616-21. doi: 10.1111/j.1442-2042.2012.03229.x. Epub 2012 Nov 19.
PubMed 23163835Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.
PubMed 22840867Jung JW, Lee BK, Park YH, Lee S, Jeong SJ, Lee SE, Jeong CW. Modified Seoul National University Renal Stone Complexity score for retrograde intrarenal surgery. Urolithiasis. 2014 Aug;42(4):335-40. doi: 10.1007/s00240-014-0650-7. Epub 2014 Mar 13.
PubMed 24623504
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Prediction of Flexible Ureteroscopy Outcome in the Treatment of Renal Calculi
- ClinicalTrials.gov ID
- NCT05857501
- Acronym / sponsor ID
- FURS outcome prediciton
- Conditions
- Flexible Ureteroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 12 May 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.
To predict the outcome of flexible ureteroscopy in the management of renal stones based on preoperative scoring module using five preoperative parameters that have effect on stone free status postoperatively.
Detailed description
Although flexible ureteroscopy has been in use for decades, neither the European Association of Urology (EAU) nor the American Urological association (AUA), in their clinical guidelines, recommends flexible ureteroscopy (FURS) as a first-line procedural treatment for renal stones . Several reports showed that FURS is a suitable alternative to shockwave lithotripsy (SWL) and percutaneous nephrolithotripsy (PCNL) for the treatment of renal stones, with potentially higher stone-free rates than SWL and lower morbidity than PCNL.
Safe and effective removal by FURS of multiple and large intrarenal stones, including lower pole calculi, has been documented suggesting that FURS is effective for complex intrarenal stone removal . With the multitude of available procedures, selection of the optimal one for management of renal stone is becoming more challenging.
Established models for predicting the outcomes of SWL and PCNL exist . However, a predictive model for predicting the outcome of URS is still in development , particularly for FURS treatment of renal stones. Four scores have been developed for FURS. Two of these have been compared and validated in different cohorts: the Resolu Unsal Stone Score (RUSS) and modified Seoul National University Renal Stone Complexity (S-ReSC) score , the other two scores, the S.T.O.N.E score described by Molina et al. and Ito's nomogram.
Many studies have demonstrated that stone volume is the most significant factor predictive of stone-free status (SF) after FURS. The investigators speculate that stone volume combined with other variables might improve prediction of SF after FURS. The aim of the present study is to evaluate various preoperative parameters as predictors of FURS outcome based on the Ito's nomogram
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with renal stones that are < 2 cm in maximal diameter will be recruited to the study. Patients will be counseled for flexible ureteroscopy, and the procedure will be explained to them with discussion about its pros and cons. Patients agreeable to enrollment will sign an informed written consent after fulfillment of ethical approval forms.Stone free rate will be assessed at one week, one month, and three months post-operatively using Plain X-ray for radio-opaque stones and NCCT for radiolucent stones. Stone free rate will be determined by no stone fragment > 4mm. Number of ancillary procedures required to reach SF will be reported
Key inclusion criteria (2 listed)
- Renal stones (≤ 2 cm)
- Radiolucent stone resistant to SWL and oral chemical dissolution treatment (≤2cm)
Key exclusion criteria (3 listed)
- Large stones (> 2 cm).
- Staghorn stone (stone involving the renal pelvis and more than two calyces).
- Patient preference of other treatment modality
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 |
|---|---|---|
| abdominopelvic computerized tomography (CT) without contrastAlso: digital KUB (plain x-ray on urology system )scan combines a series of X-ray images taken from different angles around your body and uses computer processing to create cross-sectional images (slices) of the bones, blood vessels and soft tissues inside your body. CT scan images provide more-detailed information than plain X-rays do. | Device | – |
Primary outcome
stone free rate after flexible ureteroscopy
Time frame: baseline
the investigators predict the outcome of flexible ureteroscopy in the management of renal stones based on preoperative scoring module using five preoperative parameters that have effect on stone free rate postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 17993340Preminger GM, Tiselius HG, Assimos DG, Alken P, Buck C, Gallucci M, Knoll T, Lingeman JE, Nakada SY, Pearle MS, Sarica K, Turk C, Wolf JS Jr; EAU/AUA Nephrolithiasis Guideline Panel. 2007 guideline for the management of ureteral calculi. J Urol. 2007 Dec;178(6):2418-34. doi: 10.1016/j.juro.2007.09.107. No abstract available.
- Background: PubMed 11713390Tiselius HG, Ackermann D, Alken P, Buck C, Conort P, Gallucci M; Working Party on Lithiasis, European Association of Urology. Guidelines on urolithiasis. Eur Urol. 2001 Oct;40(4):362-71. doi: 10.1159/000049803.
- Background: PubMed 22372915El-Nahas AR, Ibrahim HM, Youssef RF, Sheir KZ. Flexible ureterorenoscopy versus extracorporeal shock wave lithotripsy for treatment of lower pole stones of 10-20 mm. BJU Int. 2012 Sep;110(6):898-902. doi: 10.1111/j.1464-410X.2012.10961.x. Epub 2012 Feb 28.
- Background: PubMed 22757752Cohen J, Cohen S, Grasso M. Ureteropyeloscopic treatment of large, complex intrarenal and proximal ureteral calculi. BJU Int. 2013 Mar;111(3 Pt B):E127-31. doi: 10.1111/j.1464-410X.2012.11352.x. Epub 2012 Jul 3.
- Background: PubMed 18405758Pearle MS, Lingeman JE, Leveillee R, Kuo R, Preminger GM, Nadler RB, Macaluso J, Monga M, Kumar U, Dushinski J, Albala DM, Wolf JS Jr, Assimos D, Fabrizio M, Munch LC, Nakada SY, Auge B, Honey J, Ogan K, Pattaras J, McDougall EM, Averch TD, Turk T, Pietrow P, Watkins S. Prospective randomized trial comparing shock wave lithotripsy and ureteroscopy for lower pole caliceal calculi 1 cm or less. J Urol. 2008 May;179(5 Suppl):S69-73. doi: 10.1016/j.juro.2008.03.140.
- Background: PubMed 22093679Akman T, Binbay M, Ozgor F, Ugurlu M, Tekinarslan E, Kezer C, Aslan R, Muslumanoglu AY. Comparison of percutaneous nephrolithotomy and retrograde flexible nephrolithotripsy for the management of 2-4 cm stones: a matched-pair analysis. BJU Int. 2012 May;109(9):1384-9. doi: 10.1111/j.1464-410X.2011.10691.x. Epub 2011 Oct 28.
- Background: PubMed 18571315Breda A, Ogunyemi O, Leppert JT, Schulam PG. Flexible ureteroscopy and laser lithotripsy for multiple unilateral intrarenal stones. Eur Urol. 2009 May;55(5):1190-6. doi: 10.1016/j.eururo.2008.06.019. Epub 2008 Jun 13.
- Background: PubMed 18207179Breda A, Ogunyemi O, Leppert JT, Lam JS, Schulam PG. Flexible ureteroscopy and laser lithotripsy for single intrarenal stones 2 cm or greater--is this the new frontier? J Urol. 2008 Mar;179(3):981-4. doi: 10.1016/j.juro.2007.10.083. Epub 2008 Jan 22.
- Background: PubMed 22145599Takazawa R, Kitayama S, Tsujii T. Successful outcome of flexible ureteroscopy with holmium laser lithotripsy for renal stones 2 cm or greater. Int J Urol. 2012 Mar;19(3):264-7. doi: 10.1111/j.1442-2042.2011.02931.x. Epub 2011 Dec 6.
- Background: PubMed 21684557Wiesenthal JD, Ghiculete D, Ray AA, Honey RJ, Pace KT. A clinical nomogram to predict the successful shock wave lithotripsy of renal and ureteral calculi. J Urol. 2011 Aug;186(2):556-62. doi: 10.1016/j.juro.2011.03.109.
- Background: PubMed 16952658Kanao K, Nakashima J, Nakagawa K, Asakura H, Miyajima A, Oya M, Ohigashi T, Murai M. Preoperative nomograms for predicting stone-free rate after extracorporeal shock wave lithotripsy. J Urol. 2006 Oct;176(4 Pt 1):1453-6; discussion 1456-7. doi: 10.1016/j.juro.2006.06.089.
- Background: PubMed 23353048Smith A, Averch TD, Shahrour K, Opondo D, Daels FP, Labate G, Turna B, de la Rosette JJ; CROES PCNL Study Group. A nephrolithometric nomogram to predict treatment success of percutaneous nephrolithotomy. J Urol. 2013 Jul;190(1):149-56. doi: 10.1016/j.juro.2013.01.047. Epub 2013 Jan 23.
Related trials for Flexible Ureteroscopy
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
RecruitingObservational study
Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
Kidney Calculi, Nephrolithiasis
Not yet recruiting
Ureteral Access Strategies in Retrograde Intrarenal Surgery
Nephrolithiasis, Kidney 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.
Mohamed Abdelgaber Selim, ASS-PROF principal investigator
menofia universtiy
Questions about this trial
What is this clinical trial studying?
An observational study of Flexible Ureteroscopy, run by Menoufia University.
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 3 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Islam Mohamed Abu-Bakr Mansour, M.B.B.Ch (201069121037, islam_mansour@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rate after flexible ureteroscopy (time frame: baseline). 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 NCT05857501, which also lists 19 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 12 May 2023.