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NCT Number: NCT07730892

PCNL Versus RIRS for Management of Stones in Solitary Kidney

Few studies compared PCNL and RIRS for stones in solitary kidney. Current guidelines do not provide clear recommendations concerning the management of renal stones in patients with solitary kidney. The study aims to compare the safety and efficacy of the use of percutaneous nephrolithotomy (PCNL) and flexible ureteroscopy in the treatment of renal stones _ ≤ 3 cm in largest diameter through a prospective non randomized study in the period between August 2024 and August 2026. Stone-free rate will be assessed by NCCT done at 1st day postoperative and after 3 months. For Evaluation of kidney function postoperatively, creatinine clearance will be done after 1month and renal isotope scan will be done after 3 months. In addition, the results will be compared to the data of the patients with solitary kidney and renal stones who were retrospectively treated by PCNL or RIRS in the period between 2002 and 2024. The cases should fulfil the same inclusion criteria of the prospective study.

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Key information

Conditions

Renal Stones Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology center , Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with anatomical or functional solitary kidney.
  • Renal stones ≤ 3 cm in largest diameter- as measured by non-contrast spiral CT
  • Age ≥ 18 years.

Exclusion criteria

  • Patients who did not meet the above criteria.
  • bleeding diathesis or those on anticoagulant therapy.
  • concomitant pathology as ureteric stricture or renal congenital anomalies .

Treatment and study plan

retrograde intra renal surgery (RIRS)

Procedure

standard retrograde intrarenal surgery (RIRS) for management of stones in solitary kidney

Percutaneous Nephrolithotomy (PCNL)

Procedure

standard percutaneous nephrolithotomy (PCNL) for management of stones in solitary kidney

Primary outcomes

  1. stone free rate

    Time frame: within 3 months after surgery

    Stone-free status: it will be assessed by NCCT (defined as the absence of any stones or presence of only clinically insignificant residual stones < 4 mm as measured by NCCT). Sub classified to

    • Initial stone free rate (1st day postoperative)
    • Final stone free rate (after 3 months)

Secondary outcomes

  1. complication rate

    Time frame: within 30 days after surgery

    intra-operative and post operative complications according to clavien- dindo classification

  2. number of sessions

    Time frame: 3 months after surgery

    number of sessions needed to achieve complete stone clearance

  3. renal function evaluation

    Time frame: within 3 months after surgery

    renal function assessed by eGFR

  4. auxiliary procedures

    Time frame: within 3 months after surgery

    need for auxiliary procedures after primary intervention

  5. hospital stay

    Time frame: from date of surgery until hospital discharge ( up to 30 days )

    duration of postoperative hospital stay

  6. renal function evaluation

    Time frame: within 1 month after surgery

    assessment of renal function by serum creatinine

  7. renal function evaluation

    Time frame: within 3 months after surgery

    assessment of renal function by DTPA renography

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery for Management of Stones in Solitary Kidney: Assessment of Outcomes and Complications Through a Prospective Non Randomized Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

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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