Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones (SPT-CYSTO Tria)
Transurethral Cystolithotripsy With Versus Without Adjunctive Suprapubic Tube Drainage for Bladder Stones >2 cm: A Prospective Randomized Controlled Trial
Bladder stones larger than 2 cm are commonly treated by endoscopic fragmentation through the urethra. During transurethral cystolithotripsy for large stones, the procedure may be prolonged because of poor visibility, stone dust, bladder overdistension, and repeated need for irrigation or evacuation.
This randomized controlled trial will compare standal Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with the same procedure plus an adjunctive 8 Fr suprapubic catheter used only for bladder drainage during the operation. The suprapubic catheter will not be used for stone fragmentation or stone extraction.
The main outcome will be total operative time. Secondary outcomes will include fragmentation and clearance time, laser activation time, total laser energy, irrigation volume, visibility-related interruptions, stone-free rate at 30 days, complications, catheter duration, postoperative pain, and hospital stay.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
This is a prospective, randomized, controlled, parallel-group clinical trial conducted at the Department of Urology, Beni-Suef University Hospital, Faculty of Medicine, Beni-Suef University, Egypt. Adult patients with radiologically confirmed bladder stones greater than 2 cm who are scheduled for elective transurethral cystolithotripsy will be enrolled after written informed consent.
Participants will be randomized in a 1:1 ratio into two groups. The control group will undergo standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with conventional irrigation and transurethral evacuation only. The experimental group will undergo the same procedure with adjunctive 8 Fr suprapubic catheter drainage inserted under ultrasound guidance and cystoscopic visualization. The suprapubic catheter will be connected to free drainage during lithotripsy to assist bladder decompression and irrigation outflow. It will not be used for stone fragmentation, stone extraction, tract dilation, sheath placement, or percutaneous cystolithotripsy.
All procedures will use the same standardized cystoscopic access, Holmium:YAG laser platform, irrigation system, and transurethral evacuation method. The primary outcome is total operative time, measured from cystoscope insertion into the urethra until endoscopic confirmation of complete stone clearance and completion of final urethral catheter placement. Postoperative follow-up will continue for 30 days, including assessment of stone-free status by imaging and recording of perioperative complications.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Hany F Badawy, MD
- Puhelinnumero: +201149525028
- Sähköposti: HANYFATHY86@GMAIL.COM
Opiskelupaikat
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, Egypti
- Rekrytointi
- Department of Urology- Beni-Suef University Hospitals
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Päätutkija:
- Hany F Badawy, MD
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Ottaa yhteyttä:
- Hany F Badawy, MD
- Puhelinnumero: 01149525028
- Sähköposti: HANYFATHY86@GMAIL.COM
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Ottaa yhteyttä:
- Sähköposti: HANYFATHY86@GMAIL.COM
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Age 18 years or older.
- Radiologically confirmed bladder stone with maximum diameter greater than 2 cm.
- Scheduled for elective transurethral cystolithotripsy.
- Sterile urine culture before surgery, or adequately treated urinary tract infection according to culture sensitivity.
- Fit for spinal or general anesthesia.
- Ability to provide written informed consent.
Exclusion Criteria:
- Urethral stricture preventing safe cystoscopic access.
- Active uncontrolled urinary tract infection or sepsis.
- Neurogenic bladder with severely impaired bladder emptying requiring chronic catheterization.
- History of bladder cancer or suspected bladder tumor requiring simultaneous transurethral resection of bladder tumor.
- Coagulopathy or uncorrected bleeding tendency.
- Patients requiring concomitant transurethral resection of the prostate, Holmium laser enucleation of the prostate, or other prostate surgery in the same session.
- Previous pelvic radiotherapy or major lower urinary tract reconstruction.
- Pregnancy.
- Refusal to participate.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Active Comparator: Standard Transurethral Cystolithotripsy
Participants assigned to this arm will undergo standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with conventional irrigation and transurethral evacuation only, without adjunctive suprapubic catheter drainage.
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Standardized transurethral Holmium:YAG laser cystolithotripsy performed through a 17 Fr cystoscope sheath, with conventional irrigation and transurethral evacuation of stone dust and fragments.
A urethral Foley catheter will be inserted at the end of the procedure.
This procedure will be performed in both study arms.
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Kokeellinen: Transurethral Cystolithotripsy With Suprapubic Drainage
Participants assigned to this arm will undergo the same standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath, with adjunctive 8 Fr suprapubic catheter drainage inserted under ultrasound guidance and cystoscopic visualization for bladder drainage and decompression during lithotripsy.
No stone fragmentation or extraction will be performed through the suprapubic route
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Insertion of an 8 Fr suprapubic catheter under ultrasound guidance and cystoscopic visualization during transurethral cystolithotripsy.
The catheter will be connected to free drainage to assist bladder decompression and irrigation outflow during lithotripsy.
It will not be used for stone fragmentation, stone extraction, tract dilation, sheath placement, or percutaneous cystolithotripsy.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Total Operative Time
Aikaikkuna: During the surgical procedure
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Total operative time will be measured in minutes from insertion of the cystoscope into the urethra until endoscopic confirmation of complete bladder stone clearance and completion of final urethral catheter placement.
In the suprapubic drainage group, the time required for insertion of the 8 Fr suprapubic catheter will be included because the study evaluates the overall procedural efficiency of adding adjunctive suprapubic cathe+ drainage
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During the surgical procedure
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Stone Fragmentation and Clearance Time
Aikaikkuna: During the surgical procedure
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Time measured in minutes from the start of Holmium:YAG laser lithotripsy until endoscopic confirmation of complete bladder stone fragmentation and clearance
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During the surgical procedure
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Total Laser Energy
Aikaikkuna: During the surgical procedure
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Total Holmium:YAG laser energy delivered during cystolithotripsy, recorded in joules from the laser device.
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During the surgical procedure
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Visibility-Related Interruptions
Aikaikkuna: During the surgical procedure
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Number of intraoperative interruptions of lithotripsy due to poor endoscopic vision, stone dust, bladder overdistension, clot, or need for evacuation or irrigation adjustment.
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During the surgical procedure
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Urethral Catheter Duration
Aikaikkuna: From end of surgery until catheter removal, up to 30 days
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Duration of postoperative urethral Foley catheterization, measured from the end of surgery until catheter removal.
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From end of surgery until catheter removal, up to 30 days
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Postoperative Pain Score
Aikaikkuna: 6 hours and 24 hours after surgery
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Postoperative pain will be assessed using the Visual Analogue Scale.
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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6 hours and 24 hours after surgery
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University hospital
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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