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

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)
• Overall Status: Completed
• CT.gov ID: NCT03344120
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.3
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Symptoms and Signs; Pain; Ureteral Calculi	Other: Administration of USSQ Symptoms questionnaire after stent positioning	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial
• Actual Study Start Date: Jan 8, 2020
• Actual Primary Completion Date: Nov 2, 2020
• Actual Study Completion Date: Dec 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: suture stent suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.	Other: Administration of USSQ Symptoms questionnaire after stent positioning; Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy
Active Comparator: conventional double-J stent conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.	Other: Administration of USSQ Symptoms questionnaire after stent positioning; Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy

Outcome Measures

Primary Outcome Measures

1. Urinary Symptom Index Score [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 Outcome Measures

1. USSQ domains' scores [14 days]

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

2. USSQ domains' scores [2 days]

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

3. USSQ single answers [14 day]

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

4. USSQ single answers [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 [6 weeks]

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

6. complications and adverse events [2 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Città della Salute e della Scienza	Turin		Italy	10126

Sponsors and Collaborators

• Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

• Principal Investigator: Andrea Bosio, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Bosio, MD Urologist, PhD, Azienda Ospedaliera Città della Salute e della Scienza di Torino
• ClinicalTrials.gov Identifier: NCT03344120
• Other Study ID Numbers: AOUCSSTURAB004
• First Posted: Nov 17, 2017
• Last Update Posted: Dec 30, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrea Bosio, MD Urologist, PhD, Azienda Ospedaliera Città della Salute e della Scienza di Torino: Symptoms and Signs; Pain; Ureteral Calculi; Ureteroscopy; Ureteral Stents
• Additional relevant MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi

Study Results

No Results Posted as of Dec 30, 2020