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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07415993
Enrollment
96
Registered
2026-02-17
Start date
2020-06-30
Completion date
2024-03-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Sexual Function

Keywords

Anti-reflux Ureteral Stents, Standard Double J Tubes, ED, LUTS, IIEF

Brief summary

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.

Interventions

PROCEDURERoutine 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.

Sponsors

Rong Wang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
change in IIEF scorePatients were followed up postoperatively according to a bi-weekly schedule, with clinical assessments at 2, 4, 6, and 8 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026