- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01781117
Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia
Prognostic Value of the Urinary Nerve Growth Factor (NGF) in the Patients With Benign Prostatic Hyperplasia (BPH) Who Undergo Holmium Laser Enucleation of the Prostate (HoLEP)
Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). Levels of the urinary nerve growth factor (NGF), produced by bladder urothelium and smooth muscle, are increased in the patients with overactive bladder (OAB), and decreased after the OAB symptoms were improved. Also, urinary NGF levels are increased in patients with benign prostatic obstruction (BPO), but the changes of the NGF levels after relief of the BPO by the medical or surgical treatment have not been fully investigated. If the elevated urinary NGF levels are reduced after successful surgical treatment of BPO, measurement of urinary NGF could be a useful objective tool to assess the therapeutic outcomes of the operation.
The aims of this study are to measure the urinary NGF levels in patients with BPO and to compare the results between the patients with detrusor overactivity (DO) and without detrusor overactivity (Non-DO), average 2 weeks before Holmium Laser Enucleation of the Prostate (HoLEP) procedure. After HoLEP, urinary NGF levels are rechecked at the periods of postoperative 3 months and 6 months, and compare changes between the two groups.
Studieoversigt
Status
Detaljeret beskrivelse
- Investigators are going to enroll age-matched control group and measure the urinary NGF levels as a baseline value (30 males).
- Investigators are going to enroll BPO patients group (DO group 50 and Non-DO group 50 patients).
- Administration of the anti-cholinergic agents was reported to decrease urinary NGF levels. Investigators are going to try to avoid the effect of anti-muscarinic drugs.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Seoul, Korea, Republikken, 135-710
- Samsung Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male aged 50 yrs or greater
- International prostatic symptom score >= 12
- Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
- Ability and willingness to correctly complete the micturition diary and questionnaire
- Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
Exclusion Criteria:
- Patients with urologic malignancies such as prostate cancer and bladder cancer
- Patients underwent urethral, prostate surgery
- Patients with urethral stricture or bladder diverticulum or bladder neck contracture
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: HoLEP group
Holmium Laser Enucleation of the Prostate (HoLEP)
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Enucleation of the enlarged nodule of prostate and morcellation of the resected tissue.
Holmium laser enucleation and morcellation
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Difference in the baseline urinary NGF level between patients with and without detrusor overactivity at 6 months after HoLEP procedure
Tidsramme: 6 months after HoLEP procedure
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6 months after HoLEP procedure
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Difference in the IPSS (International Prostate Symptom Score) and uroflowmetry results between the patients with or without detrusor overactivity
Tidsramme: 6 months after HoLEP procedure
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6 months after HoLEP procedure
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Andre resultatmål
Resultatmål |
Tidsramme |
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Difference in the serum PSA (Prostate Specific Antigen) level between the patients with or without detrusor overactivity
Tidsramme: 6 months after HoLEP procedure
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6 months after HoLEP procedure
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kyu-Sung Lee, M.D., Ph.D., Samsung Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012-11-013
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Kliniske forsøg med Holmium Laser Enucleation of the Prostate (HoLEP)
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University of Kansas Medical CenterRekruttering
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University of Kansas Medical CenterRekrutteringNedre urinvejssymptomer | ProstatakræftForenede Stater
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Assistance Publique - Hôpitaux de ParisAfsluttetBenign prostatahyperplasiFrankrig
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IRCCS San RaffaeleUkendtBenign prostatahyperplasiItalien
-
Cairo UniversityTheodor Bilharz Research InstituteAfsluttetHan | BPH med urinvejsobstruktionEgypten
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Royal Victoria Hospital, CanadaMcGill UniversityAfsluttetBenign prostatahyperplasiCanada
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I.M. Sechenov First Moscow State Medical UniversityTilmelding efter invitationBPH | Prostata obstruktionDen Russiske Føderation
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Mansoura UniversityAfsluttetProstata hypertrofi | Holmium laser | Thulium laser | Bipolar diatermi | Prostata EnucleationEgypten
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Cairo UniversityTheodor Bilharz Research InstituteAfsluttetHan | BPH med urinvejsobstruktionEgypten
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Cairo UniversityAfsluttetHan | BPH med urinvejsobstruktionEgypten