- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07306767
Ultrahang IPP az orvosi kezelésre adott válasz előrejelzésére LUTS/BPH-ben
Az intravézicalis prosztata-kibújás ultrahangos becslésének szerepe a gyógyszeres terápia válaszának előrejelzésében alsó vizeletúti tünetekkel járó, jóindulatú prosztata-hiperpláziás betegeknél
This prospective cohort study evaluated whether transabdominal ultrasound measurement of intravesical prostatic protrusion predicts symptom severity and response to medical therapy in men aged 50 years or older with lower urinary tract symptoms secondary to benign prostatic hyperplasia. At baseline, participants underwent clinical evaluation, laboratory assessment including prostate-specific antigen, symptom scoring using the International Prostate Symptom Score and quality of life index, uroflowmetry, and transabdominal ultrasonography to measure prostate volume, bladder parameters, post-void residual urine, detrusor wall thickness, and intravesical prostatic protrusion. Participants were grouped by intravesical prostatic protrusion grade (less than 5 millimetres, 5 to 10 millimetres, and greater than 10 millimetres) and were followed for six months with reassessments at three and six months to evaluate response to medical therapy and identify patients who required escalation of treatment or surgical intervention.
A tanulmány áttekintése
Állapot
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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Cairo Governorate
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Cairo, Cairo Governorate, Egyiptom, 11511
- Ain Shams University Hospitals
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Men aged 50 years or older with moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia attending urology outpatient services at Ain Shams University Hospitals.
Leírás
Inclusion Criteria:
- Male participants aged 50 years or older.
- Lower urinary tract symptoms secondary to benign prostatic hyperplasia.
- Moderate to severe symptoms with International Prostate Symptom Score 15 to 35.
- Prostate volume 30 to 100 millilitres.
- Maximum urinary flow rate less than 15 millilitres per second.
- No hydronephrosis due to bladder outlet obstruction.
- Normal prostate-specific antigen or normal free-to-total prostate-specific antigen ratio.
Exclusion Criteria:
- History of prostate, bladder, or lower urinary tract surgery.
- Neurological disease affecting lower urinary tract function.
- Active urinary tract infection and/or symptomatic urinary tract stones.
- Post-void residual urine volume greater than 200 millilitres.
- Urethral stricture.
- Prostate cancer or bladder cancer.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: COHORT
- Időperspektívák: PROSPECTIVE
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
IPP Grade I (<5 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion less than 5 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters. |
Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (<5 millimetres), Grade II (5-10 millimetres), or Grade III (>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol. Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. |
|
IPP Grade II (5-10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion 5 to 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters. |
Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (<5 millimetres), Grade II (5-10 millimetres), or Grade III (>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol. Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. |
|
IPP Grade III (>10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion greater than 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters. |
Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (<5 millimetres), Grade II (5-10 millimetres), or Grade III (>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol. Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in International Prostate Symptom Score
Időkeret: Baseline and 6 months
|
The International Prostate Symptom Score was used to quantify lower urinary tract symptom severity. The outcome was the change in total score between baseline (pre-treatment) and the 6-month follow-up visit. The International Prostate Symptom Score (IPSS) is a seven-item questionnaire assessing lower urinary tract symptom severity. Each item is scored from 0 to 5, giving a total score ranging from 0 to 35, with higher scores indicating more severe symptoms. The outcome was the change in total IPSS from baseline to the 6-month follow-up visit. |
Baseline and 6 months
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in quality of life score
Időkeret: Baseline and 6 months
|
Change in the quality of life index associated with the Intenational Prostate Symptom Score between baseline and 6 months. The International Prostate Symptom Score quality-of-life (IPSS-QoL) question is a single item scored from 0 to 6, where 0 indicates the best quality of life and 6 indicates the worst quality of life related to urinary symptoms. Higher scores indicate worse quality of life. The outcome was the change in IPSS-QoL score from baseline to the 6-month follow-up visit. |
Baseline and 6 months
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Change in maximum urinary flow rate
Időkeret: Baseline and 6 months
|
Change in maximum urinary flow rate measured by uroflowmetry between baseline and 6 months. |
Baseline and 6 months
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Change in post-void residual urine volume
Időkeret: Baseline and 6 months
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Change in post-void residual urine volume measured by transabdominal ultrasonography between baseline and 6 months. |
Baseline and 6 months
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Change in detrusor wall thickness
Időkeret: Baseline and 6 months
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Change in detrusor wall thickness measured by transabdominal ultrasonography between baseline and 6 months. |
Baseline and 6 months
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Need for escalation of management during follow-up
Időkeret: Up to 6 months
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Proportion of participants who required escalation of management during follow-up (for example, change or intensification of medical therapy or referral for surgical management) due to persistent symptoms or poor objective improvement. |
Up to 6 months
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Urogenitális betegségek
- Nemi szervek betegségei
- Nemi szervek betegségei, férfi
- Prosztata betegségek
- Férfi urogenitális betegségek
- Urológiai betegségek
- Női urogenitális betegségek
- Női urogenitális betegségek és terhességi szövődmények
- Urológiai megnyilvánulások
- Húgyhólyag-betegségek
- Húgycső betegségek
- Húgycső elzáródás
- Kóros állapotok, jelek és tünetek
- Jelek és tünetek
- Prosztata hiperplázia
- Alsó húgyúti tünetek
- A húgyhólyag nyakának elzáródása
- A gyógyszerek élettani hatásai
- A farmakológiai hatás molekuláris mechanizmusai
- Hormonok, hormonpótló anyagok és hormonantagonisták
- Enzim gátlók
- Neurotranszmitter szerek
- Szteroid szintézis gátlók
- Hormonantagonisták
- Adrenerg szerek
- Adrenerg antagonisták
- Farmakológiai intézkedések
- Kémiai tevékenységek és felhasználások
- Adrenerg alfa-antagonisták
- 5-alfa reduktáz gátlók
Egyéb vizsgálati azonosító számok
- FMASU MS 848/2025
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
De-identified individual participant data collected during the study will be shared, including baseline and follow-up measurements (International Prostate Symptom Score and quality of life index, uroflowmetry parameters, transabdominal ultrasound parameters including intravesical prostatic protrusion, prostate volume, post-void residual urine, and detrusor wall thickness), along with a data dictionary. Direct identifiers will be removed and data will be coded prior to sharing.
IPD megosztási időkeret
De-identified data will be available beginning 6 months after study completion and will remain available for 5 years.
IPD-megosztási hozzáférési feltételek
Data will be shared with qualified researchers upon reasonable request and after review and approval by the study investigators and the institutional administration. Requesters must submit a proposal outlining objectives and planned analyses and must sign a data use agreement that prohibits re-identification and limits use to the approved purpose.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
- ANALYTIC_CODE
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