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NCT Number: NCT06862141

Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Management of Renal Stones Using Flexible Ureteroscopy

Urinary calculus is a globally recognized urological condition, with prevalence rates ranging from 1% to 13% across different geographical regions (1) Therapeutic approaches for renal calculi encompass extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). Treatment plans depend on the characteristics of calculi, patient factors, surgeon experience and the condition of medical centers. According to the guidelines of American Urologic Association (AUA) and European Association of Urology (EAU), patients with a burden of less than 20 mm in kidney calculi can choose RIRS as the frst-line surgical treatment with good stone-free rate (SFR). (2, 3) The application of RIRS for urinary stones has increased signifcantly, and the indications have expanded due to developments in minimally invasive technology and equipment. (4) With the development of stone retrieval devices and miniaturized fexible ureteroscopes, RIRS is more widely used for treating renal calculi, even for high burden stones. (5, 6) The application of ureteral access sheath (UAS) in RIRS can improve surgical vision, reduce intrarenal pressure (IRP), and decrease postoperative infectious complications. (7-9) Several reports have demonstrated the superiority of suctioning UAS, including shorter operation time, higher SFR and lower incidence of infectious complications compared with traditional ureteral access sheath, but none of these suctioning UAS can reach the renal calyces. (10-12)

A novel tip-flexible suctioning ureteral access sheath with flexible terminal was designed, which delivered the tip of the ureteral access sheath to renal calyces. However, data comparing novel tip-flexible suctioning ureteral access and traditional ureteral access sheath is lacking in RIRS.

Therefore, we designed a prospective controlled analysis to compare the efficacy and safety of novel tip-flexible suctioning ureteral access sheath and traditional ureteral access sheath combined with flexible ureteroscope (FURS) in treating renal calculi.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Menoufia University

Shebin Elkom, Menoufia, 35111, Egypt

Location status: Recruiting

Location contact

Mohamed Ibrahim Abozaid

CONTACT

[email protected]

+201068588750

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis: Radiologically confirmed renal stones (e.g., CT, ultrasound, or X-ray).
  • Stone size within a specific range (e.g., 5-20 mm).
  • Indication for Treatment: patients indicated for flexible ureteroscopy due to renal stones.
  • Anatomical Suitability: normal or mildly altered renal anatomy that allows safe use of the access sheath.
  • Willingness to participate and provide written informed consent.

Exclusion criteria

  • - Medical Conditions: Active urinary tract infection (UTI) or sepsis. Coagulopathy or inability to discontinue anticoagulation therapy. Significant comorbidities (e.g., severe cardiopulmonary disease). Pregnancy: Pregnant or breastfeeding individuals.
  • Anatomical or Surgical Factors:

Severe ureteral stricture or obstruction preventing sheath placement. Congenital abnormalities affecting the urinary tract. - Stone Factors: Stones larger than the sheath's operational limit (e.g., >20 mm). Multiple stones in different calyces that cannot be accessed in one session.

  • Previous Treatment: Recent (<6 weeks) or repeated interventions for the same stones (e.g., prior lithotripsy or ureteroscopy).

Treatment and study plan

bendable suction ureteral access sheath

Device

flexible ureteroscopy will be done using bendable suction ureteral access sheath

conventional suction ureteral access sheath

Device

flexible ureteroscopy will be done using conventional suction ureteral access sheath

Primary outcomes

  1. Immediate stone free rate

    Time frame: one day postoperative

    measured by the number of cases has the status of No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.

Secondary outcomes

  1. 3 month stone free rate

    Time frame: 3 months postoperatively

    measured by number of cases has the status of No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.

  2. duration of hospital stay

    Time frame: 2 weeks

    measured by number of days from the day of operation till the discharge day

  3. secondary intervention

    Time frame: 3 months

    measured by the number of interventions received post randomization

  4. complications

    Time frame: 3 months

    measured by the number of complications experienced by the patients

  5. costs

    Time frame: 3 months postoperatively

    measured by the total costs of patient during hospitalization and up to 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Kamal Omar

CONTACT

[email protected]

+201066949454

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Treatment of Renal Stones Using Flexible Ureteroscopy: a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 6, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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