Pediatric Bladder StonesNCT03294239
Transurethral Versus Percutaneous Endoscopic Management of Bladder Stones in Boys
A study testing Transurethral extraction of bladder stone(s) and percutaneous extraction of bladder stone(s) in people with Pediatric Bladder Stones, run by Assiut University at 1 site in Egypt.
Trial summary
To compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years Read more about this study
- Who is it for?
- Ages 1 month to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pediatric Bladder Stones
- What is being tested?
- Transurethral extraction of bladder stone(s) and percutaneous extraction of bladder stone(s)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Sep 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 1 month to 14 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Boys less than 14 yrs old age with bladder or urethral stones less than 3 cm.
Who cannot join
- Neurogenic bladder. Augmented bladder. Upper urinary tract stones that needs simultaneous ureteroscopy, PNL or ureteral stent insertion.
- Bleeding tendency. Urethral stricture. Stone in fossa navicularis that can be extracted after meatotomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transurethral Versus Percutaneous Endoscopic Management of Bladder Stones in Boys: A Comparative Prospective Randomized Study
To compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years
Read the detailed description
Pediatric urolithiasis remains endemic in developing nations, affecting children at ages less than 1 year to adolescence. The prevalence rate is high at 5% to 15% compared with 1% to 5% in developed countries. Recent studies have shown that the percentage of bladder stones in pediatric urolithiasis is 30%.
Open cystolithotomy has been the traditional modality to treat bladder stones. It has the inherent problems of a long scar, prolonged catheterization and hospitalization and risk of wound infection .The advent of improved endoscopic techniques in the form of gradual decrease in endoscopic sizes and the development of effective lithotripters have made trans urethral endoscopic management of bladder stones feasible. Excellent stone-free rates with trans urethral lithotripsy with minimal complications make it a preferred treatment option . However, in children especially boys, the small caliber of urethra raise concerns about the ability of stone fragments clearance and the possibility of iatrogenic urethral stricture occurrence. This renders trans urethral cystolithotripsy to be more difficult and unfavorable .
Per cutaneous cystolithotomy (PCCL) can be a safe alternative with low morbidity and complication rate. It has been performed safely for bladder stones up to 5 cm in size. This procedure may carry many advantages in the form of short operative time, more feasible stone fragments retrieval and less need for stone disintegration with its possible sequel as mucosal perforation or stone escaping inside the bladder that prolong the operative time.
On the other hand PCCL has important disadvantages such as the presence of an incision, the need to dilate a tract and the potential need for a urethral catheter or supra pubic tube. There are other reported complications including paralytic ileus, abdominal distention from escape of irrigating fluid into the abdominal cavity and urine leakage. It also carries a risk of bowel injury especially if there is a history of abdominal or pelvic surgery.
To the best of our knowledge, no previous prospective studies compared between per cutaneous and trans urethral approaches for endoscopic management of bladder stones in male children.
The aim of the study is to compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years.
- Conditions
- Pediatric Bladder Stones
- Being tested
- Transurethral extraction of bladder stone(s), percutaneous extraction of bladder stone(s)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral extraction of bladder stone(s)Procedure or surgery
Patients will have transurethral approach for management of their bladder stones. Either pneumatic or Holmium:YAG laser will be used for stone distentegration. Stone basket and/or Elics current evacuation will be used to retrieve stone fragments. Urethral catheter will be applied for 48 hours.
percutaneous extraction of bladder stone(s)Procedure or surgery
Patients will have percutaneous approach for management of their bladder stones. After initial cystoscopy a Foley's urethral catheter will be fixed for continuous irrigation. Then, the bladder will be filled to capacity with normal saline. Access to the distended bladder will be obtained by 10-gauge needle in the midline 1-2 cm above the pubic bone. Once suitable placement is confirmed with return of fluid, a guide wire will be passed through the needle into the bladder. Dilatation will be done using 8-10 Fr coaxial dilators then single fascial dilator with placement of 16 Fr Amplatz sheath as a working tract. No ultrasonic or fluoroscopic guidance will be used. Stone basket will be used to extract the stone. If the stones were larger than the used sheath, disintegration will be performed with a pneumatic lithotrite. Primary skin closure of the suprapubic stab wound by one stitch will be done and the urethral catheter will remain for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Transurethal group) | Experimental | Patients will have trans urethral approach for management of their bladder stones. Either pneumatic or Holmium:YAG laser will be used for stone disintegration. Stone basket and/or Elics current evacuation will be used to retrieve stone fragments. Urethral catheter will be applied for 48 hours. Receives: Procedure: Transurethral extraction of bladder stone(s) |
| Group B (Percutaneous group) | Experimental | Patients will have per cutaneous approach for management of their bladder stones. After initial cystoscopy a Foley's urethral catheter will be fixed for continuous irrigation. Then, the bladder will be filled to capacity with normal saline. Access to the distended bladder will be obtained by 10-gauge needle in the mid line 1-2 cm above the pubic bone. Once suitable placement is confirmed with return of fluid, a guide wire will be passed through the needle into the bladder. Dilatation will be done using 8-10 Fr coaxial dilators then single fascial dilator with placement of 16 Fr Amplatz sheath as a working tract. No ultrasonic or fluoroscopic guidance will be used. Stone basket will be used to extract the stone. If the stones were larger than the used sheath, disintegration will be performed with a pneumatic lithotrite. Primary skin closure of the suprapubic stab wound by one stitch will be done and the urethral catheter will remain for 48 hours. Receives: Procedure: percutaneous extraction of bladder stone(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free state
The number of patients with no residual stone fragments with no need to shift to other modality or auxiliary maneuver
Measured: 1 week post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Bladder StonesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Alaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294239
- Sponsor's protocol ID
- TUEMBS
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2017
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral Versus Percutaneous Endoscopic Management of Bladder Stones in Boys: A Comparative Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03294239
- Acronym / sponsor ID
- TUEMBS
- Conditions
- Pediatric Bladder Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 27 Sep 2017 (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 compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years
Detailed description
Pediatric urolithiasis remains endemic in developing nations, affecting children at ages less than 1 year to adolescence. The prevalence rate is high at 5% to 15% compared with 1% to 5% in developed countries. Recent studies have shown that the percentage of bladder stones in pediatric urolithiasis is 30%.
Open cystolithotomy has been the traditional modality to treat bladder stones. It has the inherent problems of a long scar, prolonged catheterization and hospitalization and risk of wound infection .The advent of improved endoscopic techniques in the form of gradual decrease in endoscopic sizes and the development of effective lithotripters have made trans urethral endoscopic management of bladder stones feasible. Excellent stone-free rates with trans urethral lithotripsy with minimal complications make it a preferred treatment option . However, in children especially boys, the small caliber of urethra raise concerns about the ability of stone fragments clearance and the possibility of iatrogenic urethral stricture occurrence. This renders trans urethral cystolithotripsy to be more difficult and unfavorable .
Per cutaneous cystolithotomy (PCCL) can be a safe alternative with low morbidity and complication rate. It has been performed safely for bladder stones up to 5 cm in size. This procedure may carry many advantages in the form of short operative time, more feasible stone fragments retrieval and less need for stone disintegration with its possible sequel as mucosal perforation or stone escaping inside the bladder that prolong the operative time.
On the other hand PCCL has important disadvantages such as the presence of an incision, the need to dilate a tract and the potential need for a urethral catheter or supra pubic tube. There are other reported complications including paralytic ileus, abdominal distention from escape of irrigating fluid into the abdominal cavity and urine leakage. It also carries a risk of bowel injury especially if there is a history of abdominal or pelvic surgery.
To the best of our knowledge, no previous prospective studies compared between per cutaneous and trans urethral approaches for endoscopic management of bladder stones in male children.
The aim of the study is to compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Transurethal group) | Experimental | Procedure: Transurethral extraction of bladder stone(s)Patients will have trans urethral approach for management of their bladder stones. Either pneumatic or Holmium:YAG laser will be used for stone disintegration. Stone basket and/or Elics current evacuation will be used to retrieve stone fragments. Urethral catheter will be applied for 48 hours. |
| Group B (Percutaneous group) | Experimental | Procedure: percutaneous extraction of bladder stone(s)Patients will have per cutaneous approach for management of their bladder stones. After initial cystoscopy a Foley's urethral catheter will be fixed for continuous irrigation. Then, the bladder will be filled to capacity with normal saline. Access to the distended bladder will be obtained by 10-gauge needle in the mid line 1-2 cm above the pubic bone. Once suitable placement is confirmed with return of fluid, a guide wire will be passed through the needle into the bladder. Dilatation will be done using 8-10 Fr coaxial dilators then single fascial dilator with placement of 16 Fr Amplatz sheath as a working tract. No ultrasonic or fluoroscopic guidance will be used. Stone basket will be used to extract the stone. If the stones were larger than the used sheath, disintegration will be performed with a pneumatic lithotrite. Primary skin closure of the suprapubic stab wound by one stitch will be done and the urethral catheter will remain for 48 hours. |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Boys less than 14 yrs old age with bladder or urethral stones less than 3 cm.
Key exclusion criteria (2 listed)
- Neurogenic bladder. Augmented bladder. Upper urinary tract stones that needs simultaneous ureteroscopy, PNL or ureteral stent insertion.
- Bleeding tendency. Urethral stricture. Stone in fossa navicularis that can be extracted after meatotomy.
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 |
|---|---|---|
| Transurethral extraction of bladder stone(s)Patients will have transurethral approach for management of their bladder stones. Either pneumatic or Holmium:YAG laser will be used for stone distentegration. Stone basket and/or Elics current evacuation will be used to retrieve stone fragments. Urethral catheter will be applied for 48 hours. | Procedure or surgery | Group A (Transurethal group) |
| percutaneous extraction of bladder stone(s)Patients will have percutaneous approach for management of their bladder stones. After initial cystoscopy a Foley's urethral catheter will be fixed for continuous irrigation. Then, the bladder will be filled to capacity with normal saline. Access to the distended bladder will be obtained by 10-gauge needle in the midline 1-2 cm above the pubic bone. Once suitable placement is confirmed with return of fluid, a guide wire will be passed through the needle into the bladder. Dilatation will be done using 8-10 Fr coaxial dilators then single fascial dilator with placement of 16 Fr Amplatz sheath as a working tract. No ultrasonic or fluoroscopic guidance will be used. Stone basket will be used to extract the stone. If the stones were larger than the used sheath, disintegration will be performed with a pneumatic lithotrite. Primary skin closure of the suprapubic stab wound by one stitch will be done and the urethral catheter will remain for 48 hours. | Procedure or surgery | Group B (Percutaneous group) |
Primary outcome
stone free state
Time frame: 1 week post operative
The number of patients with no residual stone fragments with no need to shift to other modality or auxiliary maneuver
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 1 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 Transurethral extraction of bladder stone(s) and percutaneous extraction of bladder stone(s) in people with Pediatric Bladder Stones, 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 1 inclusion and 2 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 1 Sep 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?
stone free state (time frame: 1 week post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.