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NCT Number: NCT03344120

Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial

Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted after most of ureteroscopies. Stent-related symptoms (SRS) represent a major issue. Many research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture reaching the bladder, showing decreased SRS and good tolerance. To date, these promising results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a marketed PSS. Thus, we designed a prospective single-blind RCT to compare SRS caused by marketed PSS and conventional DJ after uncomplicated URS for stone treatment.

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Key information

Conditions

Symptoms and Signs Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Ureteral Calculi Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Città della Salute e della Scienza

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ureteral or renal stones < 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy
  • stone-free procedure and absence of intraprocedural complications
  • WHO performance status 0-2

Exclusion criteria

  • significant residual fragments at the end of the procedure
  • intraprocedural complications (e.g. ureteral damage or stricture)
  • indwelling double J stent
  • acute kidney failure
  • urinary tract infection
  • urinary tract abnormalities
  • pathologies or medications potentially influencing voiding pattern and pain perception

Treatment and study plan

Administration of USSQ Symptoms questionnaire after stent positioning

Other

Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy

Primary outcomes

  1. Urinary Symptom Index Score

    Time frame: 14 days

    to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery.

Secondary outcomes

  1. USSQ domains' scores

    Time frame: 14 days

    to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery

  2. USSQ domains' scores

    Time frame: 2 days

    to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery

  3. USSQ single answers

    Time frame: 14 day

    to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery

  4. USSQ single answers

    Time frame: 2 days

    to compare USSQ single answers of suture stent and double J group, 2 days after surgery

  5. 2 weeks USSQ domains' subscores adjusted for baseline

    Time frame: 6 weeks

    to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group

  6. complications and adverse events

    Time frame: 2 weeks

    to compare complications and adverse events of suture stent and double J group

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Official study title

Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Dec 30, 2020

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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