Quality of LifeTreataprostNCT05306314
Retrospective Chart Review of Treataprost Added to Antibiotic Treatment in Patients With Chronic Prostatitis
An observational study of Quality of Life and Infection, Bacterial, run by GMG Grand Medical at 4 sites in Turkey (Türkiye).
Trial summary
Multicenter, Retrospectivecohort study in patients with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) and 140 patients without other significant comorbidities will be participated. Read more about this study
- Who is it for?
- Ages 18 to 79 years, men only
- Conditions the study is for
- Quality of Life, Infection, Bacterial, PSA
- What is being tested?
- TREATAPROST
- Type of treatment
- Pill or oral medicine
- How many people
- 140 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 15 Oct 2023
- 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 18 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: non-probability samples
Who may be able to join
- Patients must be ≥ 18 years old and male.
- The participant must be willing and competent to give written informed consent. If the subject is unable to consent on his behalf, a legally acceptable representative (ie, acceptable to the International Council for Harmonization [ICH] and local law as appropriate) must give informed consent on his behalf.
- Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) diagnosed with standard antibiotic therapy with NSAID and antibiotic therapy with NSAID together with Treataprost patients
Who cannot join
- In patients with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) not receiving any treatment
- For Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) taking an herbal preparation other than Treataprost in addition to standard antibiotic therapy and NSAID
- Patients who have participated in any clinical trial and received an investigational product
- Patients who did not give written informed consent
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
18 Mart University Faculty of Medicines
Çanakkale, 17020
TR Ministry of Health Eskişehir City Hospital
Eskişehir, 26080
Coşkun Kaya, Ass.Prof.Dr., +90 506 443 4154, coskun_kaya2008@yahoo.com
Coşkun Kaya
Süleyman Demirel University Faculty of Medicines
Isparta, 32260
Taylan Oksay, Prof.Dr., +90 532 3557375, droksay@gmail.com
Taylan Oksay, Prof.Dr.
Manisa Celal Bayar University Hafsa Sultan Hospital
Manisa, 45030
Gökhan Temeltaş, Prof.Dr., +90 506 399 2519, temeltasg@gmail.com
Gökhan Temeltaş
About this study
Official title: A Study to Understand the Treatment Patterns in Patients With Chronic Bacterial Prostatitis (Category II), Chronic Pelvic Pain (Category IIIA, IIIB)Treataprost Added to Standard Antibiotic Treatment in Real-life Clinical Practice
Multicenter, Retrospectivecohort study in patients with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) and 140 patients without other significant comorbidities will be participated.
The aim of the study is to collect post-treatment data to evaluate inflammation, infection status and quality of life with standard antibiotic therapy with NSAID and added Treataprost effect.
Read the detailed description
This study will be conducted in Patients with Confirmed Chronic Prostatitis and the datas of these patients will be recorded.
In real clinical practice, the data of patients who received Treataprost in addition to antibiotic therapy with NSAIDs will be recorded.
This is a non-invasive retrospective cohort study.
The primary endpoint of this study is:
- To determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB)
- Treataprost added to standard antibiotic therapy and NSAID in clinical practice, Chronic Prostatitis, Chronic in patients with Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) understanding treatment patterns
The secondary endpoint of this study is:
- The aim of the study will to evaluated gather detailed information about the effect on quality of life of Treataprost given with standard antibiotic therapy and NSAID.
- It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID
- Conditions
- Quality of Life, Infection, Bacterial, PSA, Prostatitis
- Being tested
- TREATAPROST
- Medical subject headings
- Bacterial Infections, Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREATAPROSTDietary supplement
Also called Treatarost Advance
oral administration before meals 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| TREATAPROST 0 mL( BID- 10mL*2) PO | Treataprost 10 mL ( 5 mL 2*1- PO ) 42 days Generic Name : Treatarost Advance Dosage Form: Suspension, vials of 250 mL Dosage : 250 mL Frequency : 2*1 (BID) Duration: 42 days (6 weeks) Administration:Oral administration before meals 30 minutes as 20 mL(10mL*2) Receives: Dietary Supplement: TREATAPROST | |
| Antibiotic Treatment (1*1) PO + NSAID (PRN) PO ya da SUPP | Levolon 500 mg ( 1*1 -PO) 28 daANTIBIOTIC TREATMENT Levolon 500 mg ( 1*1 - PO) 28 days (4 weeks) Dosage Form:Film-coated tablet Dosage : 500 mg Frequency : 1*1 Duration: 28 days (4 weeks) Administration:It should be taken orally, without chewing, with a sufficient amount of water. The tablets can be taken during or between meals.
NSAID Diclomec 75 mg ( PRN- PO )- 28 days (4 weeks) Dosage Form:Tablet Dosage : 75 mg Frequency : PRN Duration: 28 days (4 weeks as per needed) Administration:It should be taken orally, without chewing, with a sufficient amount of water. The tablets can be taken during or between meals. Receives: Dietary Supplement: TREATAPROST |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB)
Determining the relationship between the disease and collecting socio-demographic information such as age, education level, lifestyle
Measured: once
Treataprost added to standard antibiotic therapy and NSAID in clinical practice, Chronic Prostatitis, Chronic in patients with Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) understanding treatment patterns
Collecting data on Treataprost treatment added to standard antibiotic treatment and NSAID in clinical practice
Measured: once
Secondary outcomes (2)
The aim of the study will to evaluated gather detailed information about the effect on quality of life of Treataprost given with standard antibiotic therapy and NSAID.
To collect gather detailed information qualirt of life after post treatment
Measured: Once
• It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID
To collect gather detailed information the infection status after post treatment
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start15 Apr 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GMG Grand Medical
- Sponsor type
- University, hospital or other
- Collaborators
- Gama CRO Tıbbi İlaç Araştırma Org.Tic.Ltd.Şti
- Responsible party
- Sponsor
- Investigators
- Coşkun Kaya, Ass.Prof.Dr., Principal investigator, TR Ministry of Health Eskişehir City HospitalGökhan Temeltaş, Prof.Dr., Principal investigator, Manisa Celal Bayar University Hafsa Sultan HospitalCabir Alan, Prof. Dr., Principal investigator, Çanakkale Onsekiz Mart UniversityTaylan Oksay, Prof.Dr., Principal investigator, Süleyman Demirel University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306314
- Sponsor's protocol ID
- GMG.22.TRT.01
- Acronym
- Treataprost
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD plan is not clear as the decision has not been performed yet. The IPD plan will be entered.
Publications
Erdemir F, Parlaktaş BS, Uluocak N. "Prostatitlerin Patofizyolojisi, Tanısı, Tedavisi ve Değerlendirilmesindeki Yenilikler. Üroloji Bülteni. 2007;18(4):147-155.
von Staden H. Herophilus, Herophilus Chalcedonius, The art of medicine in early Alexandria: Edition, Translation and Essays. Cambridge: Cambridge University Press, 1989.
Stutzman RE, Walsh PC. In: Suprapubic and retropubik prostatectomy, 6th ed. Walsh PC, Retik AB, Stamey TA, Vaughan ED Jr, editors. Philadelphia: WB Saunders Co.; 1992. p.2851-6.
Clemens JQ, Stephens-Shields AJ, Newcomb C, Rodriguez LV, Lai HH, Bradley CS, Naliboff BD, Griffith JW, Taple BJ, Gupta P, Afari N, Harte SE, Strachan E, Guo W, Landis JR. Correlates of 1-Year Change in Quality of Life in Patients with Urologic Chronic Pelvic Pain Syndrome: Findings from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. J Urol. 2020 Oct;204(4):754-759. doi: 10.1097/JU.0000000000001080. Epub 2020 Apr 15.
PubMed 32294397Clemens JQ, Meenan RT, O'Keeffe Rosetti MC, Kimes T, Calhoun EA. Prevalence of and risk factors for prostatitis: population based assessment using physician assigned diagnoses. J Urol. 2007 Oct;178(4 Pt 1):1333-7. doi: 10.1016/j.juro.2007.05.140. Epub 2007 Aug 16.
PubMed 17706722McNaughton Collins M, Pontari MA, O'Leary MP, Calhoun EA, Santanna J, Landis JR, Kusek JW, Litwin MS; Chronic Prostatitis Collaborative Research Network. Quality of life is impaired in men with chronic prostatitis: the Chronic Prostatitis Collaborative Research Network. J Gen Intern Med. 2001 Oct;16(10):656-62. doi: 10.1111/j.1525-1497.2001.01223.x.
PubMed 11679032Krieger JN, Nyberg L Jr, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA. 1999 Jul 21;282(3):236-7. doi: 10.1001/jama.282.3.236. No abstract available.
PubMed 10422990Schaeffer AJ, Wendel EF, Dunn JK, Grayhack JT. Prevalence and significance of prostatic inflammation. J Urol. 1981 Feb;125(2):215-9. doi: 10.1016/s0022-5347(17)54976-9. No abstract available.
PubMed 7206060Khan FU, Ihsan AU, Khan HU, Jana R, Wazir J, Khongorzul P, Waqar M, Zhou X. Comprehensive overview of prostatitis. Biomed Pharmacother. 2017 Oct;94:1064-1076. doi: 10.1016/j.biopha.2017.08.016. Epub 2017 Aug 16.
PubMed 28813783Calhoun EA, McNaughton Collins M, Pontari MA, O'Leary M, Leiby BE, Landis JR, Kusek JW, Litwin MS; Chronic Prostatitis Collaborative Research Network. The economic impact of chronic prostatitis. Arch Intern Med. 2004 Jun 14;164(11):1231-6. doi: 10.1001/archinte.164.11.1231.
PubMed 15197050Krieger JN, Riley DE, Cheah PY, Liong ML, Yuen KH. Epidemiology of prostatitis: new evidence for a world-wide problem. World J Urol. 2003 Jun;21(2):70-4. doi: 10.1007/s00345-003-0329-0. Epub 2003 Apr 24.
PubMed 12712363Nickel JC, Downey JA, Nickel KR, Clark JM. Prostatitis-like symptoms: one year later. BJU Int. 2002 Nov;90(7):678-81. doi: 10.1046/j.1464-410x.2002.03007.x.
PubMed 12410746Habermacher GM, Chason JT, Schaeffer AJ. Prostatitis/chronic pelvic pain syndrome. Annu Rev Med. 2006;57:195-206. doi: 10.1146/annurev.med.57.011205.135654.
PubMed 16409145Nickel JC, Downey J, Hunter D, Clark J. Prevalence of prostatitis-like symptoms in a population based study using the National Institutes of Health chronic prostatitis symptom index. J Urol. 2001 Mar;165(3):842-5.
PubMed 11176483Coker TJ, Dierfeldt DM. Acute Bacterial Prostatitis: Diagnosis and Management. Am Fam Physician. 2016 Jan 15;93(2):114-20.
PubMed 26926407
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Understand the Treatment Patterns in Patients With Chronic Bacterial Prostatitis (Category II), Chronic Pelvic Pain (Category IIIA, IIIB)Treataprost Added to Standard Antibiotic Treatment in Real-life Clinical Practice
- ClinicalTrials.gov ID
- NCT05306314
- Acronym / sponsor ID
- Treataprost / GMG.22.TRT.01
- Conditions
- Quality of Life, Infection, Bacterial, PSA, Prostatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- GMG Grand MedicalUniversity, hospital or other
- Collaborators
- Gama CRO Tıbbi İlaç Araştırma Org.Tic.Ltd.Şti
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 1 Apr 2022 (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.
Multicenter, Retrospectivecohort study in patients with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) and 140 patients without other significant comorbidities will be participated.
The aim of the study is to collect post-treatment data to evaluate inflammation, infection status and quality of life with standard antibiotic therapy with NSAID and added Treataprost effect.
Detailed description
This study will be conducted in Patients with Confirmed Chronic Prostatitis and the datas of these patients will be recorded.
In real clinical practice, the data of patients who received Treataprost in addition to antibiotic therapy with NSAIDs will be recorded.
This is a non-invasive retrospective cohort study.
The primary endpoint of this study is:
- To determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB)
- Treataprost added to standard antibiotic therapy and NSAID in clinical practice, Chronic Prostatitis, Chronic in patients with Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) understanding treatment patterns
The secondary endpoint of this study is:
- The aim of the study will to evaluated gather detailed information about the effect on quality of life of Treataprost given with standard antibiotic therapy and NSAID.
- It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TREATAPROST 0 mL( BID- 10mL*2) PO | – | Dietary Supplement: TREATAPROSTTreataprost 10 mL ( 5 mL 2*1- PO ) 42 days Generic Name : Treatarost Advance Dosage Form: Suspension, vials of 250 mL Dosage : 250 mL Frequency : 2*1 (BID) Duration: 42 days (6 weeks) Administration:Oral administration before meals 30 minutes as 20 mL(10mL*2) |
| Antibiotic Treatment (1*1) PO + NSAID (PRN) PO ya da SUPP | – | Dietary Supplement: TREATAPROSTLevolon 500 mg ( 1*1 -PO) 28 daANTIBIOTIC TREATMENT Levolon 500 mg ( 1*1 - PO) 28 days (4 weeks) Dosage Form:Film-coated tablet Dosage : 500 mg Frequency : 1*1 Duration: 28 days (4 weeks) Administration:It should be taken orally, without chewing, with a sufficient amount of water. The tablets can be taken during or between meals. NSAID Diclomec 75 mg ( PRN- PO )- 28 days (4 weeks) Dosage Form:Tablet Dosage : 75 mg Frequency : PRN Duration: 28 days (4 weeks as per needed) Administration:It should be taken orally, without chewing, with a sufficient amount of water. The tablets can be taken during or between meals. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-probability samples
Key inclusion criteria (3 listed)
- Patients must be ≥ 18 years old and male.
- The participant must be willing and competent to give written informed consent. If the subject is unable to consent on his behalf, a legally acceptable representative (ie, acceptable to the International Council for Harmonization [ICH] and local law as appropriate) must give informed consent on his behalf.
- Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) diagnosed with standard antibiotic therapy with NSAID and antibiotic therapy with NSAID together with Treataprost patients
Key exclusion criteria (4 listed)
- In patients with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) not receiving any treatment
- For Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) taking an herbal preparation other than Treataprost in addition to standard antibiotic therapy and NSAID
- Patients who have participated in any clinical trial and received an investigational product
- Patients who did not give written informed consent
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 |
|---|---|---|
| TREATAPROSTAlso: Treatarost Advanceoral administration before meals 30 minutes | Dietary supplement | Antibiotic Treatment (1*1) PO + NSAID (PRN) PO ya da SUPP, TREATAPROST 0 mL( BID- 10mL*2) PO |
Primary outcome
To determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB)
Time frame: once
Determining the relationship between the disease and collecting socio-demographic information such as age, education level, lifestyle
Treataprost added to standard antibiotic therapy and NSAID in clinical practice, Chronic Prostatitis, Chronic in patients with Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) understanding treatment patterns
Time frame: once
Collecting data on Treataprost treatment added to standard antibiotic treatment and NSAID in clinical practice
2 secondary outcomes
The aim of the study will to evaluated gather detailed information about the effect on quality of life of Treataprost given with standard antibiotic therapy and NSAID.
Time frame: Once
• It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID
Time frame: once
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Results publicationErdemir F, Parlaktaş BS, Uluocak N. "Prostatitlerin Patofizyolojisi, Tanısı, Tedavisi ve Değerlendirilmesindeki Yenilikler. Üroloji Bülteni. 2007;18(4):147-155.
- Results publicationvon Staden H. Herophilus, Herophilus Chalcedonius, The art of medicine in early Alexandria: Edition, Translation and Essays. Cambridge: Cambridge University Press, 1989.
- Results publicationStutzman RE, Walsh PC. In: Suprapubic and retropubik prostatectomy, 6th ed. Walsh PC, Retik AB, Stamey TA, Vaughan ED Jr, editors. Philadelphia: WB Saunders Co.; 1992. p.2851-6.
- Results publication: PubMed 32294397Clemens JQ, Stephens-Shields AJ, Newcomb C, Rodriguez LV, Lai HH, Bradley CS, Naliboff BD, Griffith JW, Taple BJ, Gupta P, Afari N, Harte SE, Strachan E, Guo W, Landis JR. Correlates of 1-Year Change in Quality of Life in Patients with Urologic Chronic Pelvic Pain Syndrome: Findings from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. J Urol. 2020 Oct;204(4):754-759. doi: 10.1097/JU.0000000000001080. Epub 2020 Apr 15.
- Results publication: PubMed 17706722Clemens JQ, Meenan RT, O'Keeffe Rosetti MC, Kimes T, Calhoun EA. Prevalence of and risk factors for prostatitis: population based assessment using physician assigned diagnoses. J Urol. 2007 Oct;178(4 Pt 1):1333-7. doi: 10.1016/j.juro.2007.05.140. Epub 2007 Aug 16.
- Results publication: PubMed 11679032McNaughton Collins M, Pontari MA, O'Leary MP, Calhoun EA, Santanna J, Landis JR, Kusek JW, Litwin MS; Chronic Prostatitis Collaborative Research Network. Quality of life is impaired in men with chronic prostatitis: the Chronic Prostatitis Collaborative Research Network. J Gen Intern Med. 2001 Oct;16(10):656-62. doi: 10.1111/j.1525-1497.2001.01223.x.
- Results publication: PubMed 10422990Krieger JN, Nyberg L Jr, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA. 1999 Jul 21;282(3):236-7. doi: 10.1001/jama.282.3.236. No abstract available.
- Results publication: PubMed 7206060Schaeffer AJ, Wendel EF, Dunn JK, Grayhack JT. Prevalence and significance of prostatic inflammation. J Urol. 1981 Feb;125(2):215-9. doi: 10.1016/s0022-5347(17)54976-9. No abstract available.
- Results publication: PubMed 28813783Khan FU, Ihsan AU, Khan HU, Jana R, Wazir J, Khongorzul P, Waqar M, Zhou X. Comprehensive overview of prostatitis. Biomed Pharmacother. 2017 Oct;94:1064-1076. doi: 10.1016/j.biopha.2017.08.016. Epub 2017 Aug 16.
- Results publication: PubMed 15197050Calhoun EA, McNaughton Collins M, Pontari MA, O'Leary M, Leiby BE, Landis JR, Kusek JW, Litwin MS; Chronic Prostatitis Collaborative Research Network. The economic impact of chronic prostatitis. Arch Intern Med. 2004 Jun 14;164(11):1231-6. doi: 10.1001/archinte.164.11.1231.
- Results publication: PubMed 12712363Krieger JN, Riley DE, Cheah PY, Liong ML, Yuen KH. Epidemiology of prostatitis: new evidence for a world-wide problem. World J Urol. 2003 Jun;21(2):70-4. doi: 10.1007/s00345-003-0329-0. Epub 2003 Apr 24.
- Results publication: PubMed 12410746Nickel JC, Downey JA, Nickel KR, Clark JM. Prostatitis-like symptoms: one year later. BJU Int. 2002 Nov;90(7):678-81. doi: 10.1046/j.1464-410x.2002.03007.x.
- Individual participant dataSharing planned: Undecided. IPD plan is not clear as the decision has not been performed yet. The IPD plan will be entered.
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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.
Coşkun Kaya, Ass.Prof.Dr. principal investigator
TR Ministry of Health Eskişehir City Hospital
Gökhan Temeltaş, Prof.Dr. principal investigator
Manisa Celal Bayar University Hafsa Sultan Hospital
Cabir Alan, Prof. Dr. principal investigator
Çanakkale Onsekiz Mart University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Infection, Bacterial, run by GMG Grand Medical at 4 sites in Turkey (Türkiye).
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 4 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 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuba Gun (+905458101108, t.gun@gmgroup.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) (time frame: once). 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?
On the ClinicalTrials.gov record for NCT05306314, which also lists 51 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 1 Apr 2022.