Prostate HyperplasiaprostaticNCT04781985
Prostatic Resection Cavity Stone Post Transurethral Resection of the Prostate (TURP). A Rare Case Scenario
A study testing cystoscopy in people with Prostate Hyperplasia, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Prostatic resection cavity stone post transurethral resection of the prostate (TURP). A rare case scenario Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Hyperplasia
- What is being tested?
- cystoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Aug 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with prostatic fossa stone post TURP
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kafrelsheikh University Hospital
Prostatic resection cavity stone post transurethral resection of the prostate (TURP). A rare case scenario
Read the detailed description
Transurethral resection of the prostate (TURP) is the gold standard surgical therapy for lower urinary tract symptoms (LUTS) owing to senile prostatic enlargement. Following TURP, LUTS may persist in a percentage of patients. Persistent LUTS necessitates proper evaluation and management (1).
In a rare case report, delayed occurrence of storage and obstructive voiding symptoms after TURP can be caused by dystrophic calcification of the prostatic resection cavity and might be misinterpreted as post-TURP infection. The mechanism of dystrophic calcification entails minimizing tissue trauma by cautious removal of calcifications rather than performing extensive Re-TURP (2).
In our case, a rare presentation of storage LUTS as result of prostatic cavity stone extending into the bladder with same continuum, elicite the core issue of post TURP storage LUTS.
- Conditions
- Prostate Hyperplasia
- Being tested
- cystoscopy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cystoscopyProcedure or surgery
Also called open cystolitholapaxy
extraction of the bladder stone via suprapubic incision
| Study group | Role | What they receive |
|---|---|---|
| suprapubic cystolithotomy | Experimental | Extraction of the vesical stone via open exploration of the bladder. Receives: Procedure: cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cystscopic evaluation of the prostate
evaluation of the prostatic fossa cavity post TURP
Measured: one month
extraction of the bladder stone
surgical removal of the large bladder stone
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jun 2020
- Primary completion1 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate HyperplasiaStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Not applicable
- Intervention model
- Single group
- Model description
- surgical treatment for bladder stone
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa Eldin Taha Ramadan Mohamed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781985
- Sponsor's protocol ID
- RS/20.12
- Acronym
- prostatic
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kafrelsheikh University Hospital
- ClinicalTrials.gov ID
- NCT04781985
- Acronym / sponsor ID
- prostatic / RS/20.12
- Conditions
- Prostate Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostatic resection cavity stone post transurethral resection of the prostate (TURP). A rare case scenario
Detailed description
Transurethral resection of the prostate (TURP) is the gold standard surgical therapy for lower urinary tract symptoms (LUTS) owing to senile prostatic enlargement. Following TURP, LUTS may persist in a percentage of patients. Persistent LUTS necessitates proper evaluation and management (1).
In a rare case report, delayed occurrence of storage and obstructive voiding symptoms after TURP can be caused by dystrophic calcification of the prostatic resection cavity and might be misinterpreted as post-TURP infection. The mechanism of dystrophic calcification entails minimizing tissue trauma by cautious removal of calcifications rather than performing extensive Re-TURP (2).
In our case, a rare presentation of storage LUTS as result of prostatic cavity stone extending into the bladder with same continuum, elicite the core issue of post TURP storage LUTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- surgical treatment for bladder stone
| Arm | Type | Receives |
|---|---|---|
| suprapubic cystolithotomy | Experimental | Procedure: cystoscopyExtraction of the vesical stone via open exploration of the bladder. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient with prostatic fossa stone post TURP
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| cystoscopyAlso: open cystolitholapaxyextraction of the bladder stone via suprapubic incision | Procedure or surgery | suprapubic cystolithotomy |
Primary outcome
cystscopic evaluation of the prostate
Time frame: one month
evaluation of the prostatic fossa cavity post TURP
extraction of the bladder stone
Time frame: one month
surgical removal of the large bladder stone
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 16 Mar 2021.
- 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 cystoscopy in people with Prostate Hyperplasia, run by Kafrelsheikh 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 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
cystscopic evaluation of the prostate (time frame: one month). The study lists 2 primary outcomes in all. 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 16 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.