Efficacy And Safety Of Antegrade Uretroscopic Lithotripsy Versus Retrograde Ureteroscopic Lithotripsy In The Treatment Of Upper Ureteric Stones Measuring > 10 mm In Maximum Dimension. A Randomized Comparative Study
Phase: NA
Conditions: Upper Ureteric Stones
Sponsor: Ain Shams University

 
 PROTOCOL OF A THESIS FOR PARTIAL FULFILMENT OF M.D. 
DEGREE 
  
 
Efficacy And Safety Of Antegrade Uretroscopic Lithotripsy Versus 
Retrograde Ureteroscopic Lithotripsy In The Treatment Of Upper 
Ureteric Stones Measuring  < 10 mm In Maximum Dimension And/ 
Or Impacted Stones. A Randomized Comparative Study 
 
 
Postgraduate Student: 
Mohammad Saad Abdulbaki Hafez 
MSc in urology 
 
 
Under supervision of: 
 
Prof. Dr. Mohamed Rafik El Halaby 
Professor of urology 
Department of urology, Ain Shams University 
 
 
Prof. Dr. Mohamed Mohi-ELdin Wishahi 
Professor of urology 
Department of urology, Theodor Bilharz Research Institute 
 
 
Prof. Dr. Ahmad Gamaleldin Elbaz 
Professor of urology 
Department of urology, Theodor Bilharz Research Institute 
 
 
Dr. Mohamed Hasan Mohamed 
Lecturer of Urology 
Department of urology, Ain Shams University 
 
 
 
Ain Shams University 
2021 
 

1. INTRODUCTION/ REVIEW”  
Urolithiasis is a commonly occurring pathologic condition of the urinary tract which 
urologists worldwide are dealing with on daily basis specially with increasing 
incidence in the last years with the majority of them at upper urinary tract1. 
Upper ureteric stones specially with large size are not likely to pass spontaneously 
having a chance of 22% versus distal ureteric stones which have a chance of 71% of 
spontaneous passage2. An exact cut-off size for stones that are likely to pass 
spontaneously cannot be provided; < 10 mm may be considered a best 
estimate3.Impacted stones irrespective of size won’t pass spontaneously defined 
radiologically by non movable stone down the ureter on computerized tomography 
scan for 1 month or inability to pass a guidewire beyond the stone intraoperatively4  
Upper ureteric stones have been considered a matter of controversy when addressing 
the most convenient interventional procedure for their treatment taking in 
consideration the variety of interventional options within the armamentarium of 
contemporary urology. These options include retrograde URSL, SWL, antegrade 
URSL and ureterolithotomy, laparoscopic or open, in certain cases5. 
The European Association of Urology (EAU) and American Association of Urology 
(AUA) guidelines on urolithiasis recommended use of URSL and SWL for treating 
upper ureteric stones5,6. In the recent years there has been a paradigm shift towards 
increased use of URSL with decreased SWL use for treating upper urinary tract 
stones7,8. It has been postulated that URSL for ureteric stones has higher stone free 
rate compared to SWL with less need for secondary procedures9. Also URSL has a 
more favorable cost-efficiency profile compared to SWL in treating proximal 
ureteric stones when chosen as the primary treatment modality10. The EAU 
guidelines on urolithiasis recommends URSL as first option to treat proximal 
ureteric stones > 10 mm in maximum dimension and to use antegrade access 
whenever the collecting system is dilated or the retrograde access is inconvenient5.  
Recently many studies assessed the antegrade access for upper ureteric stones 
making use of different urological endoscopes available with different percutanous 
tract sizes through the kidney according to used endoscope varying between 
conventional nephroscopes11,semirigid ureteroscopes11, mini nephroscopes12, 
flexible nephroscopes13 and flexible ureteroscopes4 demonstrating superior stone 
free rate with percutaneous antegrade access with comparable safety profile with 
retrograde URSL.    
   
 
 
 
 

2. AIM/ OBJECTIVES (Maximum 300 words)  
We aim to assess the efficacy and safety of antegrade URSL in treating upper 
ureteric stones >10 mm in its maximum dimension and impacted upper ureteric 
stones irrespective of its size in comparison to retrograde URSL and evaluate 
feasibility, adverse events, hospital stay and cost benefit of both techniques. 

3. METHODOLOGY:   
Patients and Methods/ Subjects and Methods/ Material and Methods (Maximum 1000 words) 
“References may be needed”  
 
 Type of Study 
Randomized prospective study 
 Study Setting 
  - Department of urology, Ain Shams University 
   
 Study Period 
4 years 
 
 Study Population 
-  Inclusion Criteria: 
- Age > 18 years 
- Upper ureteric stones > 10 mm 
- Impacted upper ureteric stones defined by non movable stone on CTUT for 1 
month or      intraoperative failure to pass a guidewire beyond the stone 
- Exclusion Criteria: 
- Unresolved urinary tract infection 
- Uncorrected coagulopathy 
- pregnancy 
- Anatomical abnormalities of the urinary system as horse shoe kidney, pelvic 
ectopic kidney and ureteric strictures. 
- Severe orthopedic malformation hindering prone position or antegrade ureteric 
access as Kyphosis, scoliosis. 
- Pediatric age groups < 18 years 
- Ureteric Stent in place 

- Concurrent renal stones 
- Bladder cancer, upper urothelial tumors and renal tumors. 
 Sampling Method 
Randomization will be done by statistician. 
 Sample Size 
50 patients in either arm, aborted cases will be included. 
 Ethical Considerations 
Patients will be asked to provide a signed written informed consent  
 Study Procedures: 
 
- Pre operative work up: 
- Patients will undergo detailed history taking, physical examination. 
- Laboratory work-up: 
-  Complete blood count (CBC) 
- Coagulation profile 
-  Kidney function tests 
-  Liver function tests 
-  Urine analysis 
-  Urine culture and sensitivity 
- Imaging: 
-  Patients will undergo plain computed tomography of the urinary tract 
(CTUT) to be eligible for diagnosis of upper ureteric stone. Upper 
ureteric stone definition will be the distance from pelviureteric junction to 

the proximal border of sacroiliac junction. Impacted stones will be 
defined as non movable stones for 1 month on CTUT 
- Signed informed consent 
- 
Patients who fulfill inclusion criteria will be randomized into 2 groups: 
 Antegrade URSL( A-group),  retrograde URSL(B-group). 
- Operative procedure: 
Antegrade URSL- Group A: 
1- All patients will be anesthetized by general anesthesia. 
2- The patient will be in lithotomy position, cystoscopy will be done,  guide wire 
will be passed to the ureter to bypass the ureteric stone and advanced to the 
collecting system of the kidney,  ureteric catheter (6 Fr, open tip) will pass over the 
guidewire and an indwelling urethral catheter will be placed in the urinary bladder  
3- The patient will be placed in prone position, retrograde pyelography via ureteric 
catheter will be done, puncture of the collecting system will be done through upper 
or middle calyx using 18-gauge percutaneous puncture needle guided by 
fluoroscopy. In case of impacted stones and non passage of guidewire beyond the 
stone, localization of renal pelvis by 18 gauge Shiba needle in prone position guided 
by ultrasound will be done then antegrade pyelography will be performed to proceed 
with calyceal puncture. 
4- 0.035 inch PTFE J tip guidewire will be introduced through the puncture needle 
sheath and negotiated into the ureter down to the stone guided by fluoroscopy. 
5- Dilatation of the percutaneous tract using Amplatz dilator 14 fr and its sheath 
guided by fluoroscopy. 
6- Withdrawing ureteric catheter after passage of 0.035 inch PTFE straight guide 
wire through it to the kidney to act as safety wire guided by fluoroscopy. 
7- Passage of Ureteral access sheath 10-12 fr  or the Flexible URS itself (Richard 
Wolf, Boa Vision) on the J tip guidewire then the guidewire will be withdrawn 
8- Stone dusting using 200 micron Laser fiber and Lumenis Pulse 50H Laser 
machine utilizing Holmium Laser 
9- Antegrade ureterography via the ureterosocpe will be done at end of stone dusting 

10-  Passage of 0.035 PTFE straight tip (Boston Scientific) guidewire through the 
URS to the bladder guided by Fluoroscopy then the safety guidewire will be 
withdrawn retrogradely 
11- Ureteroscope will be withdrawn with ureteral access sheath, if used, along with 
inspection of ureter up to the kidney 
12- Antegrade JJ stent 6fr/26 will be passed antegradely over the straight guidewire 
to the bladder 
13- Amplatz sheath will be pulled out and puncture site closed with a deep mattress 
suture 
 
- Retrograde URSL- Group B: 
1- All patients will be anesthetized by general anesthesia. 
2- Patients will be placed in supine position 
3- Cystoscopy and passage of 0.035-inch straight tip guidewire in the ureter up to 
the kidney guided by fluoroscopy. 
4- 10 Fr dual lumen ureteric catheter is passed along guidewire guided by 
fluoroscopy  to pass a second safety guide wire then ureteric dilatation by Teflon 
dilators up to 14 Fr then passage of  ureteral access sheath 12-14 Fr  or the 
Flexible URS itself  ,if the ureter cannot be dilated, on one of the 2 guidewires 
guided by fluoroscopy then the guidewire will be withdrawn 
5- When using flexible ureteroscope, 200 micron  Laser fiber will be used to 
complete stone dusting 
6- Retrograde pyelography will be performed at end of procedure then 6fr/26cm JJ 
stent  will be fixed  
 
- Post operative: 
- In both groups, urethral catheter will be removed after full recovery from 
anesthesia and blood sample will be obtained on the morning of day 1 post 
operative for CBC and then patient will be discharged. 
- Patients will undergo CTUT after 3 weeks to confirm stone free state before JJ 
stent removal, stone free state will be defined as no or 2-3 mm stone fragments on 
CTUT 
 
 Data collection and deposition: Data will be collected and deposited in both 
urology departments. 

 
 
 
 
4. REFERENCES  
 
1- Scales CD Jr, Smith AC, Hanley JM, Saigal CS, Urologic Diseases in America Project. 
Prevalence of kidney stones in the United States.  Eur Urol. 2012 Jul; 62(1):160-5 
2- Morse RM, Resnick MI. Ureteral calculi: natural history and treatment in an era of 
advanced technology. J Urol.1991;145:263–265. 
3- Preminger, G.M., et al. 2007 Guideline for the management of ureteral calculi. Eur Urol, 
2007. 52: 1610. 
4- Elgebaly O, Abdeldayem H, Idris F, et al. Antegrade mini-percutaneous flexible 
ureteroscopy versus retrograde ureteroscopy for treating impacted proximal ureteric 
stones of 1-2 cm: A prospective randomised study. Arab J Urol. 2020;18(3):176-180. 
5- Türk C, Petřík A, Sarica K, Seitz C, Skolarikos A, Straub M, et al. EAU Guidelines on 
Interventional Treatment for Urolithiasis. Eur Urol. 2016;69:475-82. 
6- Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, et al. Surgical 
Management of Stones: American Urological Association/Endourological Society 
Guideline, PART I. J Urol. 2016;196:1153-60. 
7- Lee MC, Bariol SV. Evolution of stone management in Australia. BJU Int. 
2011;108(Suppl 2):29–33. 
8- Ordon M, Urbach D, Mamdani M, et al. The surgical management of kidney stone 
disease: a population-based time series analysis. J Urol. 2014;192(5):1450–1456. 
9- Drake, T., et al. What are the Benefits and Harms of Ureteroscopy Compared with Shock-
wave Lithotripsy in the Treatment of Upper Ureteral Stones? A Systematic Review. Eur 
Urol, 2017. 72: 772. 
10- Lotan Y, Gettman MT, Roehrborn CG, et al. Management of ureteral calculi: a cost 
comparison and decision making analysis. J Urol. 2002;167:1621–1629. 
11- Bhat A, Singh V, Bhat M, et al. Comparison of antegrade percutaneous versus retrograde 
ureteroscopic lithotripsy for upper ureteric calculus for stone clearance, morbidity, and 
complications. Indian J Urol. 2019;35(1):48-53. 
12- Gökce Mİ, Akpinar Ç, Obaid K, et al. Comparison of retrograde ureterorenoscopy (URS) 
and percutaneous anterograde ureteroscopy for removal of impacted upper ureteral stones 
>10mm in the elderly population. Int Braz J Urol. 2021 Jan-Feb;47(1):64-70 
13- Stavros Sfoungaristos, Ioannis Mykoniatis, Ayman Isid ET AL. Retrograde versus 
Antegrade Approach for the Management of Large Proximal Ureteral Stones. BioMed 
Research International, vol. 2016, Article ID 6521461. 
 

Informed consent 
 
Ain Shams University 
Faculty of Medicine 
Ethical Committee of Scientific research 
 
Informed consent form for parents or guardians of patients who are 
invited to participate in the research 
Research title:  
Efficacy And Safety Of Antegrade Uretroscopic Lithotripsy Versus Retrograde 
Ureteroscopic Lithotripsy In The Treatment Of Upper Ureteric Stones Measuring > 
10 mm In Maximum Dimension And/ Or Impacted Stones. A Randomized 
Comparative Study 
 
Introduction and aim of the work: 
Proximal ureteric stones comprise a frequent clinical situation facing 
urologists with the majority of them requiring interventional procedures. Various 
procedures have been implemented to address such stones as ureterorenoscopic 
lithotripsy (URSL), shock wave lithotripsy (SWL) and ureterolithotomy, either 
laparoscopic or open, in certain cases.  
The aim of the present study is to assess the efficacy and safety of antegrade 
URSL in treating upper ureteric stones >10 mm in its maximum dimension and 
impacted upper ureteric stones irrespective of its size in comparison to retrograde 
URSL and evaluate feasibility, adverse events, hospital stay and cost benefit of both 
techniques which will aid in proper use of either of them in the Egyptian urological 
society. 
Place of work: 
Bicentral study to be held at: 
  - Department of urology, Ain Shams University 
   

Number and Selection of participants: 
 Will be 100 participants, 50 patients in each group: 
Group A: antegrade ureteroscopic lithotripsy  
Group B: retrograde ureteroscopic lithotripsy 
 
Plan of the work: 
After your consent achievement and fully explained about the steps of research, 
the subjects of both groups will be subjected to the following: 
1. Clinical parameters: 
Complete history taking and thorough clinical examination 
2. Laboratory parameters: 
- Complete blood count (CBC) 
- Coagulation profile (PT, PC, INR) 
-  Kidney function tests (Serum crearinine, Na, K and uric acid) 
-  Liver function tests (SGPT, SGOT, total & direct bilirubin and 
albumin) 
-  Urine analysis 
-  Urine culture and sensitivity 
3. Radiological parameters:  
Patients will undergo plain computed tomography of the urinary tract 
(CTUT) to be eligible for diagnosis of upper ureteric stone. 
4. Operation: 
Group A: antegrade ureteroscopic lithotripsy  
Group B: retrograde ureteroscopic lithotripsy 
Both groups will be operated upon by an expert urologist with tremendous 
experience in endourilogy. 
5. Post operative: 
- In both groups, urethral catheter will be removed after full recovery from 
anesthesia and blood sample will be obtained on the morning of day 1 post 
operative 
for 
CBC 
and 
then 
patient 
will 
be 
discharged. 

- Patients will undergo CTUT after 3 weeks to confirm stone free state 
before JJ stent removal 
- our primary endpoint: stone free rate defined by no or stone fragment > 
4 mm on CTUT 
Benefits expected from the study: 
Benefits to the participants: 
Treatment of upper ureteric stone and preventing further sequelae of 
obstructive uropathy  
Benefits to the community: 
TO assess the efficacy and safety of antegrade URSL in treating upper ureteric 
stones >10 mm in its maximum dimension and impacted upper ureteric stones 
irrespective of its size which may represent a challenge for retrograde access 
 Conducting the consent: 
The consent will be conducted to the legal guardian or the patient by the 
investigator, Doctor Mohammad Saad Abdulbaki, urology specialist at  Urology 
Department, Theodor Bilharz Research Institute. Literate individuals will be left to 
read the consent followed by its explanation by the mentioned investigator, while 
illiterate individuals will have the consent read and explained to them as well. 
 
 
Risks and complications: 
This research will not expose the patient to further risks or complications 
despite the standard risks of protocol of Ain Shams University hospitals and Theodor 
Bilharz Research Institute hospital. 
 The risk of blood sampling: The blood sample will be obtained by a trained, 
professional nurse using sterile, disposable equipment. The risks of bleeding, 
bruising, or infection are small, and similar to having blood drawn at your 
doctor’ s office. Some subjects report a feeling of faintness or brief dizziness 
upon blood sampling. However, the volume of blood (5 milliliters) is small, and 
will be replaced quickly by your body.   
 As for antegrade ureteroscopic lithotripsy:  
The documented risks of general anesthesia and the endoscopic procedure as 

bleeding, hematuria, ureteric trauma, urinary tract infection and urosepsis. 
These risks can be overcome by: 
- Anethesia risk: thorough preoperative assessment of patient fitness 
for general anesthesia by experienced anesthesiologist 
- bleeding:  in case of significant intraoperative bleeding due to renal 
puncture and track dilatation, the procedure will be aborted, 
nephrostomy tube will be inserted and closed for tamponading, 
hematocrit value will be measured and blood transfusion will be 
implemented if necessary. 
- Hematuria: in case of mild hematuria, patient will receive 
intravenous fluids with good oral fluid intake and hemostatic agents as 
tranexamic acid. In case of persistent significant hematuria despite the 
abovementioned conservative measures, renal angiography and 
further intervention radiology may be needed to manage arteriovenous 
fistula if found. 
- Urinary tract infection: patients with unresolved UTI will be 
excluded. All patients will receive antibiotic prophylaxis on induction 
of anesthesia. The procedure will be done under complete aseptic 
conditions. 
- Urosepsis: multidisciplinary management will be initiated including 
ICU doctors, empirical broad spectrum antibiotics and intravenous 
fluids will be given with close monitoring of vital signs, , urine and 
blood cultures will be obtained and follow up of C Reactive protien 
and total leucocytic count. 
- Ureteric trauma: at the end of procedure retrograde and antegrade 
pyelography will be done to ensure integrity of system with no 
extravasation. In case of trauma noticed during procedure, DJ stent 
will be inserted either immediately if trauma is significant as 
perforation and extravasation or at the end of procedure if trauma is of 
less degree. 
- The procedure will be done by a urology expert with tremendous 
experience in endourology. Any complications will be reported 
directly to the supervisors of the research and dealt with following the 
well-established guideline of urology in such situations.  
 

 
 
 As for retrograde ureteroscopic lithotripsy: 
 The documented risks of general anesthesia and the endoscopic procedure as 
hematuria, urinary tract infection, urosepsis and ureteric trauma. . These risks 
can be overcome by: 
- Anethesia risk: thorough preoperative assessment of patient fitness 
for general anesthesia by experienced anesthesiologist 
- Hematuria: patient will receive intravenous fluids with good oral 
fluid intake and hemostatic agents as tranexamic acid if not 
contraindicated 
- Urinary tract infection: patients with unresolved UTI will be 
excluded. All patients will receive antibiotic prophylaxis on induction 
of anesthesia. The procedure will be done under complete aseptic 
conditions. 
- Urosepsis: multidisciplinary management will be initiated including 
ICU doctors, empirical broad spectrum antibiotics will be given with 
close monitoring of vital signs, intravenous fluids will be given, urine 
and blood cultures will be obtained and follow up of C Reactive 
protien and total leucocytic count. 
- Ureteric trauma: at the end of procedure retrograde pyelography will 
be done to ensure integrity of system with no extravasation. In case of 
trauma noticed during procedure, DJ stent will be inserted either 
immediately if trauma is significant as perforation and extravasation 
or at the end of procedure if trauma is of less dgrees. 
- The procedure will be done by a urology expert with tremendous 
experience in endourology. Any complications will be reported 
directly to the supervisors of the research and dealt with following the 
well-established guideline of urology in such situations.  
 
 
 Plain CT-UT: It carries the potential risk of radiation exposure.  
 

Reimbursements in cases of risks and complications: 
Should the patient get physically injured as a result of research-related 
procedures, doctor Mohammad Saad Abdulbaki will provide first-aid medical 
treatment. All complications will be reported to the supervisors of the research.  
Alternatives to participating:  
In case of refusing to participate in this research, the patient will be followed 
up and will receive his treatment as planned. 
 
 
Confidentiality: 
You will deal in complete confidentiality, and no one has right to read your 
patient medical information except the main researcher. After the research is 
complete, you will be informed regarding your patient `s research results and also 
further information regarding your patient `s health status. 
Right to refuse or withdraw: 
Any participant doesn`t have to take part in this research if he/she or want. 
They may also stop participating at anytime. If you have read this form and have 
decided to let your patient to participate in this study, please understand that your 
patient’ s participation is voluntary and you have the right to withdraw your consent 
or discontinue participation at any time without penalty or loss of benefits to which 
your patient is otherwise entitled. Your decision whether or not to participate in this 
study will not affect your patient’ s medical care. Individual privacy will be 
maintained in all published and written data resulting from the study.   
 
 
Contact Information: 
Questions, Concerns, or Complaints: If you have any questions, concerns or 
complaints about this research study, its procedures, risks and benefits, or 
alternative courses of treatment, you should ask the investigator, Mohammad Saad 
Abdulbaki at phone number: 050-4160192, mobile number: 01285399230. You 
can also call the assistant supervisor Dr. Mohamed Hasan at mobile number: 
01006763542. If you have any problems or concerns about the study, you can also 

call Prof. Mohamed Rafik El Halaby the main supervisor at mobile phone number: 
01222127159 
 
You do not have to sign this consent form.  But if you do not, your patient will not be able to 
participate in this research study. 
 
 
Certificate of consent: 
I have read the foregoing information, or it has been read to me. I have had 
the opportunity to ask questions about it and any questions that I ask have been 
answered to my satisfaction. I consent voluntary to participate in this research and 
understand that I have the right to withdraw from the research at any time without 
in any way affecting my patient`s medical care.  
 Name of participant: 
 Signature of legal guardian: 
 Or participant:                                
 Identity number or finger print: …………………………. 
 Date: 
I have accurately read or witnessed the accurate reading of the consent to the 
potential participant. The individual has had the opportunity to ask questions I 
confirm that the individual has given consent freely. 
 Name of researcher: Mohammad Saad Abdulbaki. 
 Signature of researcher: 
 Date: 
This proposal has been reviewed and approved by Ethical Committee of 
Scientific research, which is a committee whose task is to make sure that research 
participants are protected from harm.  
 
If you wish to find more about Ethical Committee of Scientific research. 
Contact: 
Name: 
Address: 
Telephone number: 
 

Statistical analysis 
We used the Statistical Package for Social Sciences (IBM Corp. Released 2019. IBM 
SPSS Statistics for Windows, Version 29.0. Armonk, NY: IBM Corp.) for data 
analysis. Descriptive statistics were presented as mean ± standard deviation (SD) or 
as numbers and percentages. Normality was tested using the Shapiro-Wilk test. Data 
that were normally distributed were presented as mean ± SD, while non-normally 
distributed data were presented as median and 95% confidence intervals (CIs). 
The chi-square (X2) test assessed relationships between categorical variables. For 
parametric variables, the student’s t-test was applied to compare means between 
study groups, while the Mann-Whitney U test was used to compare medians for 
variables such as stone size and hospital stay. Fisher’s exact test was employed for 
categorical variables with expected counts < 5. Spearman’s correlation was used to 
analyze relationships between non-normally distributed variables. Binary logistic 
regression was done to illustrate the odds ratio for complications. A P-value < 0.05 
was considered statistically significant.