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Clinical Trials/NCT04858750
NCT04858750
Unknown
Not Applicable

Comparison and Evaluation of USSQ (Ureteral Stent Symptom Questionnaire), OABSS (Overactive Bladder Symptom Score), and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J(Double-J) Stents in Patients Who Underwent URL (Ureteroscopic Holmium Laser Lithotripsy)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country150 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urolithiasis
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
150
Locations
1
Primary Endpoint
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Last Updated
4 years ago

Overview

Brief Summary

Indwelling double-J ureteral stent (D-J stent) are routinely placed in patients who received ureteroscopic lithotripsy (URL) in Xinhua Hospital Urology Department. At present, three types of D-J stents, namely Cook/Kang Yi Bo(KYB)/Urovisionare are used, and usually removed in the day ward four weeks after surgery. This study intends to randomly divide patients with urolithiasis based on the preoperative OABSS (overactive bladder symptom score) questionnaire into three groups, namely Cook D-J stent group, KYB anti-reflux D-J stent group, Urovision trigonal D-J stent group, with corresponding D-J stent indwelled for 4 weeks respectively. The patient's USSQ ureteral stent symptom questionnaire)scale and OABSS scale were collected at 1 week, 4 weeks (before the removal of D-J stents), and 5 weeks (1 week after removal of D-J stents) after URL operation, and the D-J stents removed from the patients were collected, and their drainage and anti-reflux effects were measured in vitro.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
May 31, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Abdominal CT scanning indicating ureteral stones or kidney stones that are less than 2 cm in diameter, and patients who are planning to undergo URL surgery.
  • Age between 18 and 80 years old and capable of providing written informed consent;
  • In general, the heart, lung, liver and kidney function are in well condition, able to tolerate surgical treatment, and comply with research requirements.

Exclusion Criteria

  • Before the onset of urolithiasis, the patient has suffered from obvious overactive bladder syndrome, or chronic lower urinary tract infection, or urinary anatomic deformities, or had previously undergone urinary tract plastic surgery.
  • Other severe complications, infections, etc. that the researchers believe may make the subject unsuitable for this study.
  • The patient is not a local resident and insists on returning to his howetown for D-J stent removal after the URL operation(so that we are unable to retrieve the D-J stent and conduct the in vitro experiment).
  • The patient refuses to sign the informed consent.

Outcomes

Primary Outcomes

Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent

Time Frame: 5 weeks (1 week after removal of D-J stent)

The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.

Secondary Outcomes

  • Drainage effect of D-J stents after being removed(4 weeks)
  • Anti-reflux effect of D-J stents after being removed(4 weeks)

Study Sites (1)

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