Male Sexual FunctionNCT07415993

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

A study testing Routine laser lithotripsy in people with Male Sexual Function, run by Rong Wang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 50 years, men only
Conditions the study is for: Male Sexual Function
What is being tested?: Routine laser lithotripsy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteChina
Study dates: 30 Jun 2020to 1 Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Jintan Affiliated Hospital of Jiangsu University
Changzhou, Jiangsu, 213000

Other trials in China

About this study

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.

Conditions: Male Sexual Function
Being tested: Routine laser lithotripsy
Keywords: Anti-reflux Ureteral Stents, Standard Double J Tubes, ED, LUTS, IIEF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Routine laser lithotripsyProcedure or surgery
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.

Study groups in NCT07415993
Study group	Role	What they receive
Group A	Experimental	anti-reflux ureteral stent(INNOVEX, Shanghai, China) Receives: Procedure: Routine laser lithotripsy
Group-T	Active comparator	standard double-J-stent Receives: Procedure: Routine laser lithotripsy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 20201 Mar 2024

First posted17 Feb 2026
Study start30 Jun 2020
Primary completion30 Dec 2023
Study completion1 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Male Sexual FunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07415993
Sponsor's protocol ID: Zhangjiagang First Hospital
Status last verified: Feb 2026
First submitted: 10 Feb 2026
Last updated: 17 Feb 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.

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
Xu L, Gao Z, Wang R, Sun Z, Gu L, Liu H. A prospective randomized trial comparing the effects of anti-reflux versus standard ureteral stents on male sexual function. Sci Rep. 2026 Feb 21;16(1):10148. doi: 10.1038/s41598-026-41187-x.
PubMed 41723278

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Male Sexual Function trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Trial Comparing the Effects of Anti-reflux Versus Standard Ureteral Stents on Male Sexual Function
ClinicalTrials.gov ID: NCT07415993
Acronym / sponsor ID: Zhangjiagang First Hospital
Conditions: Male Sexual Function
Keywords: Anti-reflux Ureteral Stents, Standard Double J Tubes, ED, LUTS, IIEF
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Rong WangUniversity, hospital or other
Study start: 30 Jun 2020 (actual)
Primary completion: 30 Dec 2023 (actual)
Study completion: 1 Mar 2024 (actual)
First posted: 17 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Procedure: Routine laser lithotripsyanti-reflux ureteral stent(INNOVEX, Shanghai, China)
Group-T	Active comparator	Procedure: Routine laser lithotripsystandard double-J-stent

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Routine laser lithotripsyRoutine 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.	Procedure or surgery	Group A, Group-T

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
Background1.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
Derived from this study: PubMed 41723278Xu L, Gao Z, Wang R, Sun Z, Gu L, Liu H. A prospective randomized trial comparing the effects of anti-reflux versus standard ureteral stents on male sexual function. Sci Rep. 2026 Feb 21;16(1):10148. doi: 10.1038/s41598-026-41187-x.
Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author upon reasonable request.

Related trials for Male Sexual Function

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Routine laser lithotripsy in people with Male Sexual Function, run by Rong Wang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in IIEF score (time frame: Patients were followed up postoperatively according to a bi-weekly schedule, with clinical assessments at 2, 4, 6, and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07415993, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.