Management of Obstructed Infected KidneyNCT03498794
Ureteral Stent Versus Percutaneous Nephrostomy in Acutely Obstructed Infected Kidney
A study testing Ureteral stent in people with Management of Obstructed Infected Kidney, run by Assiut University at 1 site in Egypt.
Trial summary
Non-malignant causes of ureter obstruction can be intrinsic such as stone disease, ureter stricture or congenital ureteropelvic junction obstruction, or extrinsic such as idiopathic retro peritoneal fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Management of Obstructed Infected Kidney
- What is being tested?
- Ureteral stent
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2019to 1 Apr 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients with infected hydronephrosis.
- Infected hydronephrosis due to ureteric stone or ureteric stricture.
- Uremic and non uremic patients.
Who cannot join
- Patients with a contraindication to either form of drainage (uncorrected coagulopathy, urethral stricture disease, bladder outlet obstruction, pregnancy, ureteral stone greater than 15 mm., or Steinstrasse).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internal Ureteral Stent Versus Percutaneous Nephrostomy Tube in Management of Acutely Obstructed Infected Kidney in the Presence Upper Urinary Tract Stones: A Prospective, Randomized Study
Non-malignant causes of ureter obstruction can be intrinsic such as stone disease, ureter stricture or congenital ureteropelvic junction obstruction, or extrinsic such as idiopathic retro peritoneal fibrosis. Nearly all clinicians agree that obstructing stones, with a concern for sepsis require immediate decompression of the urinary system.
Though large epidemiologic studies of the management of obstructed infected nephrolithiasis demonstrate higher rates of sepsis and mortality associated with PCN placement relative to ureteral stenting, the observational nature of the analysis highlights the need for prospective analyses of PCN vs stenting for obstructive nephrolithiasis.
Read more
Despite this obvious need, there are few studies comparing the efficacy of ureteral stenting vs PCN in the setting of obstructive urolithiasis. The choice between PCN and stenting is often made by the urologist at initial presentation and can be influenced by factors including disease severity, stone size, location of stone, eventual modality of definitive stone management, or even availability of in-house interventional radiology services.
Retrospective studies reveal that both procedures have high success rates. In the setting of unsuccessful stenting, PCN is often successful, but the contrary is not always true. Furthermore, patients are often selected for PCN over ureteral stenting in the setting of larger stones and if they are more severely ill.
Goldsmith et al studied 130 patients who underwent decompression for obstructing ureteral stone with PCN or stent placement. Although patients who underwent PCN placement had longer hospital stay, other outcomes such as time to definitive stone management, rates of spontaneous stone passage, and initiation of stone metabolic workup were not statistically different. The authors noted that the method of initial decompression correlated with eventual approach selected for definitive stone management. Patients treated with PCN were more likely to undergo percutaneous definitive management, while patients managed with ureteral stenting were more likely to be treatked with a ureteroscopic approach.
Two prospective studies comparing PCN vs stent management of obstructing ureteral stones have conflicting outcomes. Mokhmalji et al 6 in 2001 prospectively randomized 40 patients to receive either PCN or stent. Sixteen out of twenty stents were successfully placed while all twenty PCNs were successfully placed initially. All unsuccessful stents were successfully managed by PCN. Their results demonstrated that stent utilization was less successful as compared to PCN and there was a trend for longer antibiotic therapy due to persistent signs of urinary tract infection in patients who underwent stent placement.
In contrast, Pearle et al randomized 42 patients to receive PCN vs stents. This study failed to demonstrate one procedure to be more successful than the other. All 21stents and 20 out of 21 PCNs were successfully placed. One failed PCN successfully underwent stent placement. Their results demonstrated an increased incidence of bacterial urinary colonization post-procedure in the PCN group as compared to the stent group, but overall no differences in time to clinical improvement or length of stay were noted.
Read the detailed description
Preoperative preparation:
- History taking: complete history will be taken, including personal, past and medical history as UTI.
- Examination: Included General examination (BMI will be estimated), abdominal, and neurological examination.
- Laboratory investigations:
- Complete urine analysis: Physical, chemical and microscopic.
- Urine culture at time of insertion.
- Complete blood count (CBC).
- Renal function test.
- Radiological evaluation:
- Abdominal ultrasonography.
- Plain KUB.
- Non-contrast CT (NCCT-KUB).
How the technique will be applied?
Technique of ureteral stent insertion:
All patients will be in lithotomy position, and an endoscopy operating table with fluoroscopic imaging capability will be used. Before the procedures, all patients will have retrograde ureteropyelography. Then, a 0.035-inch hydrophilic guide wire will be placed into the renal pelvis under the guidance of flexible cystoscope.
The ureteral stent will be inserted retrograde by using flexible cystoscope, under mild sedation or local anesthesia by instilling 2% xylocain gel per urethra. Patients will be covered by specific antimicrobial therapy according to urine and/or blood culture. This treatment will be continued until there was no fever and any evidence of infection disappeared. A Foley's catheter will be left in the bladder for 2 hours in all patients. In each case the type of stent will be that of 5 or 6 F, with side-holes and remain in place until definitive treatment of stone.
Technique of PCN insertion:
Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively. The patients will be placed on the ultrasound table with fluoroscopic imaging capability in prone position and a pillow placed under the abdomen on the affected side to support the kidney. Then the initial puncture site will be chosen, cleaned and draped. Local anesthesia was injected and a stab incision was given at the puncture site. The 18-gauge Chiba needle will be inserted at the renal angle or at the posterior axillary line under ultrasound guidance into dilated pelvicalyceal system. Urine or pus drained out spontaneously or will be sucked with a disposable syringe and sample was sent to the laboratory for culture and sensitively. Then soft end of floppy J guide wire will be passed through the needle and needle was removed. The tract was dilated with Teflon facial dilators more than the diameter of the nephrostomy tube. After tract dilation a pig tail nephrostomy tube or a feeding tube of 8 Fr will be passed over the guide wire into the collecting system and secured with silk no.1. All patients were maintained on antibiotic prophylaxis after culture sample.
Operative evaluation:
- Operative time in minutes.
- Fluoroscopy time in seconds.
- Urine culture.
- Use of analgesics.
- Success of insertion.
Post operative evaluation (every week until definitive treatment of stone):
- Time to normal temperature 37.4C or less.
- Time to normal white blood count WBC of 10,000/mm.3 or less.
- Time to normal serum chemistry in case of uremic cases.
- Urine culture.
- length of hospital stay in days.
- Duration of diversion, The time until definitive stone treatment and specific treatment modality
- Duration of intravenous administration of antibiotics for high temperature)
- Quality of life (questionnaire immediately and 2 to 4 weeks postoperatively).
- The time until definitive stone treatment and specific treatment modality
- Complications were noted in immediate post-operative period and on follow up: Procedural failure, Injury to adjacent organs, Fever \& Septicemia, Bleeding/Hematuria Painful Trigone irritation, PCN dislodgement or blockage, Ureteral Perforat;ion , Stent Migration, Stent Encrustation or Stone formation
- Conditions
- Management of Obstructed Infected Kidney
- Being tested
- Ureteral stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral stentProcedure or surgery
Also called Percutanous nephrostomy tube
Patients will be randomized into 2 groups:
Group (A): 75 patients with the use of ureteral stent. Group (B): 75 patients with the use of PCN.
How the technique will be applied?
Technique of ureteral stent insertion:
The ureteral stent will be inserted retrograde by using flexible cystoscope.
Technique of PCN insertion:
Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Ureteral stent | Active comparator | Technique of ureteral stent insertion:
All patients will be in lithotomy position, and an endoscopy operating table with fluoroscopic imaging capability will be used. Before the procedures, all patients will have retrograde ureteropyelography. Then, a 0.035-inch hydrophilic guide wire will be placed into the renal pelvis under the guidance of flexible cystoscope.
The ureteral stent will be inserted retrograde by using flexible cystoscope, under mild sedation or local anesthesia by instilling 2% xylocain gel per urethra. Patients will be covered by specific antimicrobial therapy according to urine and/or blood culture. This treatment will be continued until there was no fever and any evidence of infection disappeared. A Foley's catheter will be left in the bladder for 2 hours in all patients. In each case the type of stent will be that of 5 or 6 F, with side-holes and remain in place until definitive treatment of stone. Receives: Procedure: Ureteral stent |
| Percutaneous nephrostomy tube | Active comparator | Technique of PCN insertion:
Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively. The patients will be placed on the ultrasound table with fluoroscopic imaging capability in prone position and a pillow placed under the abdomen on the affected side to support the kidney. Then the initial puncture site will be chosen, cleaned and draped. Local anesthesia was injected and a stab incision was given at the puncture site. The 18-gauge Chiba needle will be inserted at the renal angle or at the posterior axillary line under ultrasound guidance into dilated pelvicalyceal system. Urine or pus drained out spontaneously or will be sucked with a disposable syringe and sample was sent to the laboratory for culture and sensitively. Receives: Procedure: Ureteral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral stent vs percutaneous nephrostomy (PCN) for drainage obstructed infected kidney
To compare between Ureteral stent versus Percutaneous Nephrostomy tube (PCN) in management of obstructed infected kidney by Improvement of infection clinically by decreasing high body temperature.
Measured: 2 years from April 2018 to may 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start5 Mar 2019
- Primary completion10 Mar 2020
- Study completion1 Apr 2020
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 Management of Obstructed Infected KidneyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Comparison Between Ureteral Stent versus Percutaneous Nephrostomy in Obstructed infected kidney due to Ureteric calculi
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MMMohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498794
- Sponsor's protocol ID
- US VS PCN
- Status last verified
- May 2020
- First submitted
- 2 Mar 2018
- Last updated
- 11 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lynch MF, Anson KM, Patel U. Current opinion amongst radiologists and urologists in the UK on percutaneous nephrostomy and ureteric stent insertion for acute renal unobstruction: Results of a postal survey. BJU Int. 2006 Dec;98(6):1143-4. doi: 10.1111/j.1464-410X.2006.06513.x. No abstract available.
PubMed 17125470Sammon JD, Ghani KR, Karakiewicz PI, Bhojani N, Ravi P, Sun M, Sukumar S, Trinh VQ, Kowalczyk KJ, Kim SP, Peabody JO, Menon M, Trinh QD. Temporal trends, practice patterns, and treatment outcomes for infected upper urinary tract stones in the United States. Eur Urol. 2013 Jul;64(1):85-92. doi: 10.1016/j.eururo.2012.09.035. Epub 2012 Sep 25.
PubMed 23031677Ahmad I, Saeed Pansota M, Tariq M, Shahzad Saleem M, Ali Tabassum S, Hussain A. Comparison between Double J (DJ) Ureteral Stenting and Percutaneous Nephrostomy (PCN) in Obstructive Uropathy. Pak J Med Sci. 2013 May;29(3):725-9. doi: 10.12669/pjms.293.3563.
PubMed 24353616Goldsmith ZG, Oredein-McCoy O, Gerber L, Banez LL, Sopko DR, Miller MJ, Preminger GM, Lipkin ME. Emergent ureteric stent vs percutaneous nephrostomy for obstructive urolithiasis with sepsis: patterns of use and outcomes from a 15-year experience. BJU Int. 2013 Jul;112(2):E122-8. doi: 10.1111/bju.12161.
PubMed 23795789Yoshimura K, Utsunomiya N, Ichioka K, Ueda N, Matsui Y, Terai A. Emergency drainage for urosepsis associated with upper urinary tract calculi. J Urol. 2005 Feb;173(2):458-62. doi: 10.1097/01.ju.0000150512.40102.bb.
PubMed 15643207Mokhmalji H, Braun PM, Martinez Portillo FJ, Siegsmund M, Alken P, Kohrmann KU. Percutaneous nephrostomy versus ureteral stents for diversion of hydronephrosis caused by stones: a prospective, randomized clinical trial. J Urol. 2001 Apr;165(4):1088-92.
PubMed 11257644Pearle MS, Pierce HL, Miller GL, Summa JA, Mutz JM, Petty BA, Roehrborn CG, Kryger JV, Nakada SY. Optimal method of urgent decompression of the collecting system for obstruction and infection due to ureteral calculi. J Urol. 1998 Oct;160(4):1260-4.
PubMed 9751331
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Ureteral Stent Versus Percutaneous Nephrostomy Tube in Management of Acutely Obstructed Infected Kidney in the Presence Upper Urinary Tract Stones: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03498794
- Acronym / sponsor ID
- US VS PCN
- Conditions
- Management of Obstructed Infected Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 17 Apr 2018 (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.
Non-malignant causes of ureter obstruction can be intrinsic such as stone disease, ureter stricture or congenital ureteropelvic junction obstruction, or extrinsic such as idiopathic retro peritoneal fibrosis. Nearly all clinicians agree that obstructing stones, with a concern for sepsis require immediate decompression of the urinary system.
Though large epidemiologic studies of the management of obstructed infected nephrolithiasis demonstrate higher rates of sepsis and mortality associated with PCN placement relative to ureteral stenting, the observational nature of the analysis highlights the need for prospective analyses of PCN vs stenting for obstructive nephrolithiasis.
Despite this obvious need, there are few studies comparing the efficacy of ureteral stenting vs PCN in the setting of obstructive urolithiasis. The choice between PCN and stenting is often made by the urologist at initial presentation and can be influenced by factors including disease severity, stone size, location of stone, eventual modality of definitive stone management, or even availability of in-house interventional radiology services.
Retrospective studies reveal that both procedures have high success rates. In the setting of unsuccessful stenting, PCN is often successful, but the contrary is not always true. Furthermore, patients are often selected for PCN over ureteral stenting in the setting of larger stones and if they are more severely ill.
Goldsmith et al studied 130 patients who underwent decompression for obstructing ureteral stone with PCN or stent placement. Although patients who underwent PCN placement had longer hospital stay, other outcomes such as time to definitive stone management, rates of spontaneous stone passage, and initiation of stone metabolic workup were not statistically different. The authors noted that the method of initial decompression correlated with eventual approach selected for definitive stone management. Patients treated with PCN were more likely to undergo percutaneous definitive management, while patients managed with ureteral stenting were more likely to be treatked with a ureteroscopic approach.
Two prospective studies comparing PCN vs stent management of obstructing ureteral stones have conflicting outcomes. Mokhmalji et al 6 in 2001 prospectively randomized 40 patients to receive either PCN or stent. Sixteen out of twenty stents were successfully placed while all twenty PCNs were successfully placed initially. All unsuccessful stents were successfully managed by PCN. Their results demonstrated that stent utilization was less successful as compared to PCN and there was a trend for longer antibiotic therapy due to persistent signs of urinary tract infection in patients who underwent stent placement.
In contrast, Pearle et al randomized 42 patients to receive PCN vs stents. This study failed to demonstrate one procedure to be more successful than the other. All 21stents and 20 out of 21 PCNs were successfully placed. One failed PCN successfully underwent stent placement. Their results demonstrated an increased incidence of bacterial urinary colonization post-procedure in the PCN group as compared to the stent group, but overall no differences in time to clinical improvement or length of stay were noted.
Detailed description
Preoperative preparation:
- History taking: complete history will be taken, including personal, past and medical history as UTI.
- Examination: Included General examination (BMI will be estimated), abdominal, and neurological examination.
- Laboratory investigations:
- Complete urine analysis: Physical, chemical and microscopic.
- Urine culture at time of insertion.
- Complete blood count (CBC).
- Renal function test.
- Radiological evaluation:
- Abdominal ultrasonography.
- Plain KUB.
- Non-contrast CT (NCCT-KUB).
How the technique will be applied?
Technique of ureteral stent insertion:
All patients will be in lithotomy position, and an endoscopy operating table with fluoroscopic imaging capability will be used. Before the procedures, all patients will have retrograde ureteropyelography. Then, a 0.035-inch hydrophilic guide wire will be placed into the renal pelvis under the guidance of flexible cystoscope.
The ureteral stent will be inserted retrograde by using flexible cystoscope, under mild sedation or local anesthesia by instilling 2% xylocain gel per urethra. Patients will be covered by specific antimicrobial therapy according to urine and/or blood culture. This treatment will be continued until there was no fever and any evidence of infection disappeared. A Foley's catheter will be left in the bladder for 2 hours in all patients. In each case the type of stent will be that of 5 or 6 F, with side-holes and remain in place until definitive treatment of stone.
Technique of PCN insertion:
Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively. The patients will be placed on the ultrasound table with fluoroscopic imaging capability in prone position and a pillow placed under the abdomen on the affected side to support the kidney. Then the initial puncture site will be chosen, cleaned and draped. Local anesthesia was injected and a stab incision was given at the puncture site. The 18-gauge Chiba needle will be inserted at the renal angle or at the posterior axillary line under ultrasound guidance into dilated pelvicalyceal system. Urine or pus drained out spontaneously or will be sucked with a disposable syringe and sample was sent to the laboratory for culture and sensitively. Then soft end of floppy J guide wire will be passed through the needle and needle was removed. The tract was dilated with Teflon facial dilators more than the diameter of the nephrostomy tube. After tract dilation a pig tail nephrostomy tube or a feeding tube of 8 Fr will be passed over the guide wire into the collecting system and secured with silk no.1. All patients were maintained on antibiotic prophylaxis after culture sample.
Operative evaluation:
- Operative time in minutes.
- Fluoroscopy time in seconds.
- Urine culture.
- Use of analgesics.
- Success of insertion.
Post operative evaluation (every week until definitive treatment of stone):
- Time to normal temperature 37.4C or less.
- Time to normal white blood count WBC of 10,000/mm.3 or less.
- Time to normal serum chemistry in case of uremic cases.
- Urine culture.
- length of hospital stay in days.
- Duration of diversion, The time until definitive stone treatment and specific treatment modality
- Duration of intravenous administration of antibiotics for high temperature)
- Quality of life (questionnaire immediately and 2 to 4 weeks postoperatively).
- The time until definitive stone treatment and specific treatment modality
- Complications were noted in immediate post-operative period and on follow up: Procedural failure, Injury to adjacent organs, Fever \& Septicemia, Bleeding/Hematuria Painful Trigone irritation, PCN dislodgement or blockage, Ureteral Perforat;ion , Stent Migration, Stent Encrustation or Stone formation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison Between Ureteral Stent versus Percutaneous Nephrostomy in Obstructed infected kidney due to Ureteric calculi
| Arm | Type | Receives |
|---|---|---|
| Ureteral stent | Active comparator | Procedure: Ureteral stentTechnique of ureteral stent insertion: All patients will be in lithotomy position, and an endoscopy operating table with fluoroscopic imaging capability will be used. Before the procedures, all patients will have retrograde ureteropyelography. Then, a 0.035-inch hydrophilic guide wire will be placed into the renal pelvis under the guidance of flexible cystoscope. The ureteral stent will be inserted retrograde by using flexible cystoscope, under mild sedation or local anesthesia by instilling 2% xylocain gel per urethra. Patients will be covered by specific antimicrobial therapy according to urine and/or blood culture. This treatment will be continued until there was no fever and any evidence of infection disappeared. A Foley's catheter will be left in the bladder for 2 hours in all patients. In each case the type of stent will be that of 5 or 6 F, with side-holes and remain in place until definitive treatment of stone. |
| Percutaneous nephrostomy tube | Active comparator | Procedure: Ureteral stentTechnique of PCN insertion: Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively. The patients will be placed on the ultrasound table with fluoroscopic imaging capability in prone position and a pillow placed under the abdomen on the affected side to support the kidney. Then the initial puncture site will be chosen, cleaned and draped. Local anesthesia was injected and a stab incision was given at the puncture site. The 18-gauge Chiba needle will be inserted at the renal angle or at the posterior axillary line under ultrasound guidance into dilated pelvicalyceal system. Urine or pus drained out spontaneously or will be sucked with a disposable syringe and sample was sent to the laboratory for culture and sensitively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Patients with infected hydronephrosis.
- Infected hydronephrosis due to ureteric stone or ureteric stricture.
- Uremic and non uremic patients.
Key exclusion criteria (1 listed)
- Patients with a contraindication to either form of drainage (uncorrected coagulopathy, urethral stricture disease, bladder outlet obstruction, pregnancy, ureteral stone greater than 15 mm., or Steinstrasse).
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 |
|---|---|---|
| Ureteral stentAlso: Percutanous nephrostomy tubePatients will be randomized into 2 groups: Group (A): 75 patients with the use of ureteral stent. Group (B): 75 patients with the use of PCN. How the technique will be applied? Technique of ureteral stent insertion: The ureteral stent will be inserted retrograde by using flexible cystoscope. Technique of PCN insertion: Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively. | Procedure or surgery | Percutaneous nephrostomy tube, Ureteral stent |
Primary outcome
Ureteral stent vs percutaneous nephrostomy (PCN) for drainage obstructed infected kidney
Time frame: 2 years from April 2018 to may 2020
To compare between Ureteral stent versus Percutaneous Nephrostomy tube (PCN) in management of obstructed infected kidney by Improvement of infection clinically by decreasing high body temperature.
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 11 May 2020.
- Background: PubMed 17125470Lynch MF, Anson KM, Patel U. Current opinion amongst radiologists and urologists in the UK on percutaneous nephrostomy and ureteric stent insertion for acute renal unobstruction: Results of a postal survey. BJU Int. 2006 Dec;98(6):1143-4. doi: 10.1111/j.1464-410X.2006.06513.x. No abstract available.
- Background: PubMed 23031677Sammon JD, Ghani KR, Karakiewicz PI, Bhojani N, Ravi P, Sun M, Sukumar S, Trinh VQ, Kowalczyk KJ, Kim SP, Peabody JO, Menon M, Trinh QD. Temporal trends, practice patterns, and treatment outcomes for infected upper urinary tract stones in the United States. Eur Urol. 2013 Jul;64(1):85-92. doi: 10.1016/j.eururo.2012.09.035. Epub 2012 Sep 25.
- Background: PubMed 24353616Ahmad I, Saeed Pansota M, Tariq M, Shahzad Saleem M, Ali Tabassum S, Hussain A. Comparison between Double J (DJ) Ureteral Stenting and Percutaneous Nephrostomy (PCN) in Obstructive Uropathy. Pak J Med Sci. 2013 May;29(3):725-9. doi: 10.12669/pjms.293.3563.
- Background: PubMed 23795789Goldsmith ZG, Oredein-McCoy O, Gerber L, Banez LL, Sopko DR, Miller MJ, Preminger GM, Lipkin ME. Emergent ureteric stent vs percutaneous nephrostomy for obstructive urolithiasis with sepsis: patterns of use and outcomes from a 15-year experience. BJU Int. 2013 Jul;112(2):E122-8. doi: 10.1111/bju.12161.
- Background: PubMed 15643207Yoshimura K, Utsunomiya N, Ichioka K, Ueda N, Matsui Y, Terai A. Emergency drainage for urosepsis associated with upper urinary tract calculi. J Urol. 2005 Feb;173(2):458-62. doi: 10.1097/01.ju.0000150512.40102.bb.
- Background: PubMed 11257644Mokhmalji H, Braun PM, Martinez Portillo FJ, Siegsmund M, Alken P, Kohrmann KU. Percutaneous nephrostomy versus ureteral stents for diversion of hydronephrosis caused by stones: a prospective, randomized clinical trial. J Urol. 2001 Apr;165(4):1088-92.
- Background: PubMed 9751331Pearle MS, Pierce HL, Miller GL, Summa JA, Mutz JM, Petty BA, Roehrborn CG, Kryger JV, Nakada SY. Optimal method of urgent decompression of the collecting system for obstruction and infection due to ureteral calculi. J Urol. 1998 Oct;160(4):1260-4.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteral stent in people with Management of Obstructed Infected Kidney, run by Assiut University at 1 site in Egypt.
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 1 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 11 May 2020. 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 Egypt. 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?
Ureteral stent vs percutaneous nephrostomy (PCN) for drainage obstructed infected kidney (time frame: 2 years from April 2018 to may 2020). 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 NCT03498794, 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 11 May 2020.