Ecografia IPP per Predire la Risposta alla Terapia Medica in LUTS/BPH
Ruolo della stima ecografica della protrusione prostatica intravescicale nel predire la risposta alla terapia medica in pazienti con sintomi del tratto urinario inferiore secondari a iperplasia prostatica benigna
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Contatti e Sedi
Luoghi di studio
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Cairo Governorate
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Cairo, Cairo Governorate, Egitto, 11511
- Ain Shams University Hospitals
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Numero di gruppi/coorti
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in International Prostate Symptom Score
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in quality of life score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and 6 months
|
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
Lasso di tempo: Baseline and 6 months
|
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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Malattie genitali, maschio
- Malattie della prostata
- Malattie urogenitali maschili
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Manifestazioni urologiche
- Malattie della vescica urinaria
- Malattie uretrali
- Ostruzione uretrale
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Iperplasia prostatica
- Sintomi del tratto urinario inferiore
- Ostruzione del collo della vescica urinaria
- Effetti fisiologici dei farmaci
- Meccanismi molecolari dell'azione farmacologica
- Ormoni, sostituti ormonali e antagonisti ormonali
- Inibitori enzimatici
- Agenti neurotrasmettitori
- Inibitori della sintesi steroidea
- Antagonisti ormonali
- Agenti adrenergici
- Antagonisti adrenergici
- Azioni farmacologiche
- Azioni e usi chimici
- Alfa-antagonisti adrenergici
- Inibitori della 5-alfa reduttasi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- FMASU MS 848/2025
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
De-identified data will be available beginning 6 months after study completion and will remain available for 5 years.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
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