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

NCT04858750 | Unknown

• 1 other identifier: XHEC-C-2021-106-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis; Overactive Bladder Syndrome

Keywords

USSQ; OABSS; double-J stent; ureteroscopic holmium laser lithotripsy

Outcome Measures

Primary Outcomes (6)

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

  The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)

  1 week (after URL)

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

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

  1 week (after URL)

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

  The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)

  4 weeks (before removal of D-J stent)

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

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

  4 weeks (before removal of D-J stent)

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

  The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)

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

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

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

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

Secondary Outcomes (2)

• Drainage effect of D-J stents after being removed

  4 weeks

• Anti-reflux effect of D-J stents after being removed

  4 weeks

Study Arms (3)

Cook D-J stent group

OTHER

Patients randomized to this group received Cook (Limerick, Ireland, USI-626-R) D-J stent. Note: USI is an unexpandable acronym.

Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy

KYB anti-reflux D-J stent group

OTHER

Patients randomized to this group received KYB (Shenzhen, China, 3201162) anti-reflux D-J stent.

Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy

Urovision trigonal D-J stent group

OTHER

Patients randomized to this group received Urovision (Bad Aibling, Germany, ST-230726) trigonal D-J stent. Note: ST is an unexpandable acronym. Aibling is a German region name.

Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy

Interventions

Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy DEVICE

During ureteral holmium laser lithotripsy operation, after the stones were fragmented, the D-J stents of three different types were placed, the insertion process are exactly the same.

Cook D-J stent group; KYB anti-reflux D-J stent group; Urovision trigonal D-J stent group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 26, 2021
• Study Start: February 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: May 31, 2023
• Last Updated: March 22, 2022

Record last verified: 2022-02

Locations

CN (1)