Lower Urinary Tract SymptomsNCT05069376
Effect of Ureteral Stents Length and Location on Related Symptom
A study testing Ureteral Stent of 5-16 or 5-18 and Ureteral Stent of 5-22 or 5-24 in people with Lower Urinary Tract Symptoms and Overactive Bladder Syndrome, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Overactive Bladder Syndrome
- What is being tested?
- Ureteral Stent of 5-16 or 5-18 and Ureteral Stent of 5-22 or 5-24
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jun 2018to 30 May 2020
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of unilateral ureteral stone
- Plan to undergo unilateral URS lithotripsy
- Adult patients (>18 years old)
Who cannot join
- Pre-stented cases
- Distal ureteral stones
- Preoperative urinary tract infection
- With medications known to influence stent-related symptoms, including alpha-blockers, antimuscarinics, beta3-agonist
- Pregnancy
- Other procedures required during the procedure of lithotripsy
- A stent was expected to be indwelled for more than 10 days (ureteral stricture, ureteral tumors/polyps, ureteral trauma, and a large amount of stone fragments)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Shuang Ho Hospital Taipei Medical University
New Taipei City, 23561
About this study
This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain.
Read the detailed description
Intravesical stent mass has been considered to cause stent-related symptoms, such as LUTS and pain. The current study hypothesized that the total intra-ureteral placement of the stent's distal end could decrease postoperative LUTS and pain. We proposed a prospective randomized trials, investigating the effect of intra-ureteral stent placement versus conventional stent placement. The primary end point was postoperative LUTS. The secondary end points were postoperative pain and quality of life. We used USSQ questionnaire as the assessing tool.
- Being tested
- Ureteral Stent of 5-16 or 5-18, Ureteral Stent of 5-22 or 5-24
- Keywords
- Ureteral stent, OAB
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral Stent of 5-16 or 5-18Device
Boston Scientific Polaris™ Ultra Ureteral Stent
Ureteral Stent of 5-22 or 5-24Device
Boston Scientific Polaris™ Ultra Ureteral Stent
| Study group | Role | What they receive |
|---|---|---|
| The intraureteral placement of distal end of ureteral stent | Experimental | Patients randomized to this group received 5-16/5-18 D-J stent with intraureteral placement of the distal end Receives: Device: Ureteral Stent of 5-16 or 5-18 |
| The conventional placement of the distal end of ureteral stent | Active comparator | Patients randomized to this group received 5-22/5-24 D-J stent with bladder placement of the distal end Receives: Device: Ureteral Stent of 5-22 or 5-24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower urinary tract symptom after placement of D-J stent
The symptoms are evaluated by a complete USSQ (Ureteral Stent Symptom Questionnaire) urinary index. The minimum and maximum values are 11 and 53, and the higher scores mean a worse outcome
Measured: Before removal of D-J stent
Secondary outcomes (1)
Pain after placement of D-J stent
The symptoms are evaluated by a complete USSQ (Ureteral Stent Symptom Questionnaire) pain index and general health index. The minimum and maximum values of the body pain index are 2 and 43. The minimum and maximum values of the general health index are 4 and 28. The higher scores of both mean a worse outcome.
Measured: Before removal of D-J stent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start12 Jun 2018
- Primary completion25 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Model description
- Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen-Hsun Ho, Taipei Medical University Shuang Ho Hospital
- Investigators
- Chen-Hsun Ho, MD, PhD, Principal investigator, Shuang Ho Hospital Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069376
- Sponsor's protocol ID
- N201802031
- Status last verified
- Oct 2021
- First submitted
- 25 Sep 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ureteral Stents Length and Location on Related Symptom
- ClinicalTrials.gov ID
- NCT05069376
- Acronym / sponsor ID
- N201802031
- Keywords
- Ureteral stent, OAB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 6 Oct 2021 (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.
This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain.
Detailed description
Intravesical stent mass has been considered to cause stent-related symptoms, such as LUTS and pain. The current study hypothesized that the total intra-ureteral placement of the stent's distal end could decrease postoperative LUTS and pain. We proposed a prospective randomized trials, investigating the effect of intra-ureteral stent placement versus conventional stent placement. The primary end point was postoperative LUTS. The secondary end points were postoperative pain and quality of life. We used USSQ questionnaire as the assessing tool.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent
| Arm | Type | Receives |
|---|---|---|
| The intraureteral placement of distal end of ureteral stent | Experimental | Device: Ureteral Stent of 5-16 or 5-18Patients randomized to this group received 5-16/5-18 D-J stent with intraureteral placement of the distal end |
| The conventional placement of the distal end of ureteral stent | Active comparator | Device: Ureteral Stent of 5-22 or 5-24Patients randomized to this group received 5-22/5-24 D-J stent with bladder placement of the distal end |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of unilateral ureteral stone
- Plan to undergo unilateral URS lithotripsy
- Adult patients (>18 years old)
Key exclusion criteria (7 listed)
- Pre-stented cases
- Distal ureteral stones
- Preoperative urinary tract infection
- With medications known to influence stent-related symptoms, including alpha-blockers, antimuscarinics, beta3-agonist
- Pregnancy
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 |
|---|---|---|
| Ureteral Stent of 5-16 or 5-18Boston Scientific Polaris™ Ultra Ureteral Stent | Device | The intraureteral placement of distal end of ureteral stent |
| Ureteral Stent of 5-22 or 5-24Boston Scientific Polaris™ Ultra Ureteral Stent | Device | The conventional placement of the distal end of ureteral stent |
Primary outcome
Lower urinary tract symptom after placement of D-J stent
Time frame: Before removal of D-J stent
The symptoms are evaluated by a complete USSQ (Ureteral Stent Symptom Questionnaire) urinary index. The minimum and maximum values are 11 and 53, and the higher scores mean a worse outcome
1 secondary outcome
Pain after placement of D-J stent
Time frame: Before removal of D-J stent
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 18 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Chen-Hsun Ho, MD, PhD principal investigator
Shuang Ho Hospital Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteral Stent of 5-16 or 5-18 and Ureteral Stent of 5-22 or 5-24 in people with Lower Urinary Tract Symptoms and Overactive Bladder Syndrome, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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 18 Oct 2021. 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 Taiwan. 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?
Lower urinary tract symptom after placement of D-J stent (time frame: Before removal of D-J stent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2021.