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Comparison and Evaluation of USSQ, OABSS, and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J Stents in Patients Who Underwent URL

China150 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 1 week (after URL)

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

Timeframe: 1 week (after URL)

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

Timeframe: 4 weeks (before removal of D-J stent)

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

Timeframe: 4 weeks (before removal of D-J stent)

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

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

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

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

Trial details

NCT IDNCT04858750

SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-30

View on ClinicalTrials.gov More Urolithiasis trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 1 week (after URL)

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

Timeframe: 1 week (after URL)

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

Timeframe: 4 weeks (before removal of D-J stent)

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

Timeframe: 4 weeks (before removal of D-J stent)

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

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

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

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