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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344120
• Other study ID #: AOUCSSTURAB004
• Status: Completed
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: December 16, 2020

Study information

• Verified date: December 2020
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 16, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Pain
• Symptoms and Signs
• Ureteral Calculi
• Ureterolithiasis

Intervention

Other:
• Administration of USSQ Symptoms questionnaire after stent positioning
Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Symptom Index Score	to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery.	14 days
Secondary	USSQ domains' scores	to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery	14 days
Secondary	USSQ domains' scores	to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery	2 days
Secondary	USSQ single answers	to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery	14 day
Secondary	USSQ single answers	to compare USSQ single answers of suture stent and double J group, 2 days after surgery	2 days
Secondary	2 weeks USSQ domains' subscores adjusted for baseline	to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group	6 weeks
Secondary	complications and adverse events	to compare complications and adverse events of suture stent and double J group	2 weeks