A Prospective Randomized Trial Comparing the Effects of Anti-reflux Versus Standard Ureteral Stents on Male Sexual Function

Objective: To compare the effectiveness of anti-reflux ureteral stents on improving erectile function and quality of life of patients with ureteral stents.

Methods and Populations: A total of 100 male patients who required ureteral stent placement after ureteroscopic lithotripsy were randomly assigned to two groups: those in Group T (n=50) received a standard double-J-stent, while those in Group A (n=50) underwent implantation with anti-reflux ureteral stent. Follow up for 8 weeks after surgery, including reproductive hormones and inflammation marks, Beck's depression scale, IIEF and statistics on the frequency of symptoms such as hematuria.

Study Overview

• Status: Completed
• Conditions: Male Sexual Function
• Intervention / Treatment: Procedure: Routine laser lithotripsy

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Jintan Affiliated Hospital of Jiangsu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• male sexually active patients with unilateral ureteral calculi who underwent ureteroscopy with laser lithotripsy and needed post-procedure stent

Exclusion Criteria:

• Patients were excluded if they included the following criteria: (1) age under 18 or over 50 years, (2) history of previous ureteral stenting, (3) bilateral stents, (4) moderate or severe ureteral stricture need long-term stenting (on regular exchange), (5) bladder pathology and overactive bladder, (6) symptomatic benign prostatic hyperplasia, (7) moderate or severe urinary tract infection, (8) moderate or severe cardiovascular disease, hepatic dysfunction and diabetes, (9) previous use of selective alpha-1-blocker and/or antimuscarinic agent, (10) pre-op IIEF-5 ≤ 21.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; anti-reflux ureteral stent(INNOVEX, Shanghai, China)	Procedure: Routine laser lithotripsy; Routine laser lithotripsy was done for the ureteral calculi, and a 6 Fr polyurethane DJ stent (Inlay Optima®, Bard Medical, Covington, GA) or INNOVEX, according to the groups, was inserted under fluoroscopic and cystoscopic guidance. Appropriate length was adjusted according to patient's height. Routine X-ray of the kidneys, ureter and bladder (KUB) was taken for all patients before home discharge to confirm the proper stent positioning. All patients are advised to avoid alcohol, until 4 weeks after surgery when the ureteral stent is removed in our institution. General information such as preoperative age, body mass index, diameter of ureteral calculi, and degree of hydronephrosis, operation time were obtained. Follow up for 8 weeks after surgery, including reproductive hormones and inflammation marks, Beck's depression scale, IIEF and statistics on the frequency of symptoms such as hematuria.
Active Comparator: Group-T; standard double-J-stent	Procedure: Routine laser lithotripsy; Routine laser lithotripsy was done for the ureteral calculi, and a 6 Fr polyurethane DJ stent (Inlay Optima®, Bard Medical, Covington, GA) or INNOVEX, according to the groups, was inserted under fluoroscopic and cystoscopic guidance. Appropriate length was adjusted according to patient's height. Routine X-ray of the kidneys, ureter and bladder (KUB) was taken for all patients before home discharge to confirm the proper stent positioning. All patients are advised to avoid alcohol, until 4 weeks after surgery when the ureteral stent is removed in our institution. General information such as preoperative age, body mass index, diameter of ureteral calculi, and degree of hydronephrosis, operation time were obtained. Follow up for 8 weeks after surgery, including reproductive hormones and inflammation marks, Beck's depression scale, IIEF and statistics on the frequency of symptoms such as hematuria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in IIEF score	Patients were followed up postoperatively according to a bi-weekly schedule, with clinical assessments at 2, 4, 6, and 8 weeks

Collaborators and Investigators

• Sponsor: Rong Wang

Publications and helpful links

General Publications

• 1.Sorokin I, Mamoulakis C, Miyazawa K, Rodgers A, Talati J, Lotan Y. Epidemiology of stone disease across the world. World J Urol. 2017;35(9):1301-1320. doi:10.1007/s00345-017-2008-6. 2.Arora A, Sane MS, Jadhao V, Maheshwari PN. Sexual dysfunction in Indian men undergoing Double J ureteral stenting following ureteroscopy-A prospective analysis. Andrologia. 2020;52(10):e13790. doi:10.1111/and.13790. 3.Mawhorter M, Streeper NM. Advances in ureteral stent technology. Curr Opin Urol. 2022;32(4):415-419. doi:10.1097/MOU.0000000000001003. 4.Chew BH, Lange D. Advances in ureteral stent development. Curr Opin Urol. 2016;26(3):277-282. doi:10.1097/MOU.0000000000000275. 5.CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025;389:e081123. Published 2025 Apr 14. doi:10.1136/bmj-2024-081123. 6.Arena S, Iacona R, Impellizzeri P, et al. Physiopathology of vesico-ureteral reflux. Ital J Pediatr. 2016;42(1):103. Published 2016 Nov 29. doi:10.1186/s13052-016-0316-x. 7.Zhang L, Wu Y, Chen Y, et al. Triangular prismatic JJ stent does not cause more discomfort than tubular ones: a randomised controlled trial comparison. World J Urol. 2024;42(1):67. Published 2024 Feb 3. doi:10.1007/s00345-023-04758-5. 8.Wen KC, Li ZA, Liu JH, Zhang C, Zhang F, Li FQ. Recent developments in ureteral stent: Substrate material, coating polymer and technology, therapeutic function. Colloids Surf B Biointerfaces. 2024;238:113916. doi:10.1016/j.colsurfb.2024.113916. 9.Hatzimouratidis K, Amar E, Eardley I, et al. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol. 2010;57(5):804-814. doi:10.1016/j.eururo.2010.02.020. 10.De Nunzio C, Roehrborn CG, Andersson KE, McVary KT. Erectile Dysfunction and Lower Urinary Tract Symptoms. Eur Urol Focus. 2017;3(4-5):352-363. doi:10.1016/j.euf.2017.11.004.2024;383(6683):eade8064. doi:10.1126/sci

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ED; LUTS; IIEF; Anti-reflux Ureteral Stents; Standard Double J Tubes
• Other Study ID Numbers: Zhangjiagang First Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study are available from the corresponding author upon reasonable request.
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results
• IPD Sharing Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No