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Impact of Concomitant TURP on Bladder Stone Surgery Outcomes

16. september 2026 opdateret af: Mahmoud Abdallah, Beni-Suef University

Impact of Concomitant Transurethral Resection of the Prostate on Postoperative Outcomes of Bladder Stone Surgery and Predictors of Subsequent TURP: A Prospective Comparative Study

The management of bladder stones secondary to benign prostatic hyperplasia (BPH) remains controversial regarding whether transurethral resection of the prostate (TURP) should be performed concomitantly or selectively.

The primary objective of this prospective randomized comparative study is to compare the postoperative outcomes of cystolitholapaxy alone versus cystolitholapaxy with concomitant TURP in adult male patients presenting with bladder calculi secondary to BPH. Additionally, the study aims to identify clinical and urodynamic predictors for requiring subsequent (delayed) TURP among patients initially treated with stone surgery alone.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Urinary bladder calculi represent approximately 5% of all urinary calculi, with secondary stones constituting the vast majority (>95%) of cases in adult men, predominantly secondary to bladder outlet obstruction (BOO) caused by benign prostatic hyperplasia (BPH).

While current guidelines debate the necessity of routine concomitant outlet obstruction relief at initial stone surgery, evidence remains needed regarding single-stage versus selective staged treatment.

This prospective, randomized, single-center study will be conducted at the Urology Department, Beni-Suef University. A total of 104 eligible male patients aged 40 years or older with symptomatic BPH (IPSS >= 8, prostate size >= 30g, Qmax <= 15 ml/s) and imaging-confirmed bladder calculus/calculi will be randomly allocated (1:1 allocation using computer-generated block randomization) into one of two parallel groups:

  • Group 1: Managed with transurethral cystolitholapaxy alone.
  • Group 2: Managed with transurethral cystolitholapaxy with concomitant TURP.

All participants undergo comprehensive preoperative evaluation including medical history, International Prostate Symptom Score (IPSS), total and free PSA, urine analysis and culture, abdominopelvic ultrasound (assessing stone dimensions, prostate volume, post-void residual urine [PVR]), and uroflowmetry (Qmax).

Follow-up evaluations are conducted at 1 month, 3 months, and 6 months postoperatively to assess the stone-free rate (SFR), stone recurrence rate, functional outcomes (IPSS, Qmax, PVR), and postoperative adverse events graded by the Clavien-Dindo classification system. Patients in Group 1 will be specifically monitored to identify independent risk factors necessitating delayed TURP during the follow-up period.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

104

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypten, 62511
        • Rekruttering
        • Faculty of Medicine, Beni-Suef University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Adult men aged 40 years or older.
  • Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH).
  • International Prostate Symptom Score (IPSS) >= 8.
  • Prostate size >= 30 grams (measured by ultrasonography).
  • Maximum urinary flow rate (Qmax) <= 15 mL/s.
  • Presence of urinary bladder calculus/calculi confirmed by diagnostic imaging.
  • Written informed consent provided prior to study enrollment.

Exclusion Criteria:

  • Evidence or history of urethral stricture.
  • Known or suspected prostate cancer.
  • Known or suspected bladder cancer / urothelial malignancy.
  • Neurogenic bladder dysfunction.
  • Chronic urinary retention with overflow incontinence.
  • Previous prostate or bladder neck surgery (e.g., prior TURP, TUIP, open prostatectomy).
  • Active urinary tract infection (UTI) at the time of surgery (patients treated for infection preoperatively may be reassessed for eligibility).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Cystolitholapaxy Alone

Patients undergo transurethral cystolitholapaxy alone to clear bladder calculi, followed by conservative medical management of BPH and follow-up to evaluate the need for subsequent delayed TURP.
Procedure: Transurethral Cystolitholapaxy Alone

Transurethral fragmentation and evacuation of bladder calculi using standard endourological equipment without surgical intervention for the prostate at the time of stone surgery.
Eksperimentel: Cystolitholapaxy + Concomitant TURP

Patients undergo transurethral cystolitholapaxy combined with simultaneous transurethral resection of the prostate (TURP) in the same operative setting.
Procedure: Transurethral Resection of the Prostate (TURP)

Transurethral resection of the prostate to relieve bladder outlet obstruction, performed in the same operative session as cystolitholapaxy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stone-Free Rate (SFR)
Tidsramme: 4 to 6 weeks postoperatively

Defined as the complete absence of residual stones evaluated using standardized imaging (urinary tract ultrasonography and plain abdominal X-ray [KUB]) for all patients.
4 to 6 weeks postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in International Prostate Symptom Score (IPSS)" Unit of Measure: Units on a Scale ( Score on a Scale)
Tidsramme: Baseline, 1 month, 3 months, and 6 months postoperatively

Evaluation of urinary symptoms and voiding parameters including International Prostate Symptom Score (IPSS, range 0-35),
Baseline, 1 month, 3 months, and 6 months postoperatively
"Change in Maximum Urinary Flow Rate (Qmax)" Unit of Measure: mL/s (milliliters per second)
Tidsramme: Baseline, 1 month, 3 months, and 6 months postoperatively

Maximum urinary flow rate (Qmax) assessed by uroflowmetry. Unit of Measure: mL/s
Baseline, 1 month, 3 months, and 6 months postoperatively
Change in Post-Void Residual Urine Volume (PVR)
Tidsramme: Baseline, 1 month, 3 months, and 6 months postoperatively

Post-void residual urine volume (PVR) assessed by ultrasonography.
Baseline, 1 month, 3 months, and 6 months postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beni-Suef University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

12. september 2026

Først indsendt, der opfyldte QC-kriterier

16. september 2026

Først opslået (Faktiske)

21. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FMBSUREC/05052026/Abdel-Azeem

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