Urinary IncontinenceNCT06068790
Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath
A study testing HoLEP Surgery, 28 French sized rigid sheath and 22 French sized rigid sheath in people with Urinary Incontinence, run by Marcelino Rivera at 2 sites in United States.
Trial summary
The rationale for this study is to assess whether there is a difference in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- HoLEP Surgery, 28 French sized rigid sheath and 22 French sized rigid sheath
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2023to 30 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age < 18 years old
- Existing stress or urge urinary incontinence
- Planned overnight admission or overnight catheterization
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health Physicians Urology
Indianapolis, Indiana, 46202
Indiana University
Indianapolis, Indiana, 46202
About this study
Official title: 28Fr Versus 22Fr HoLEP, a Randomized Controlled Trial Indiana University School of Medicine, Department of Urology
The rationale for this study is to assess whether there is a difference in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
Read the detailed description
This study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, HoLEP performed with either 1) 22Fr sheath set or 2) 28Fr sheath set. After HoLEP, data will be analyzed using chi-square test for incontinence vs no incontinence between 22Fr and 28Fr groups at 1 week, 4 weeks and 12 weeks post operatively.
- Conditions
- Urinary Incontinence
- Being tested
- HoLEP Surgery, 28 French sized rigid sheath, 22 French sized rigid sheath
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoLEP SurgeryProcedure or surgery
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
28 French sized rigid sheathDevice
Also called 28Fr
The 28Fr is the standard of care sheath size used at this site.
22 French sized rigid sheathDevice
Also called 22Fr
The 22Fr is the smaller, investigational sheath size to be used in this study.
| Study group | Role | What they receive |
|---|---|---|
| HoLEP surgery with 22Fr | Active comparator | HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr. Receives: Device: 22 French sized rigid sheath |
| HoLEP surgery with 28Fr | Experimental | HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr. Receives: Device: 28 French sized rigid sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
Measuring rates of immediate urinary incontinence or complications post-operation HoLEP using the Michigan Incontinence System Index (M-ISI) survey.
Measured: M-ISI survey completed at 1,4,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Aug 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Why it stopped: No Current scope was available to perform procedure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We hypothesize there will be lower rates of immediate urinary incontinence, and urethral stricture formation in patients undergoing HoLEP with smaller 22Fr sheaths compared to 28 Fr.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcelino Rivera
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor-investigator, Marcelino Rivera, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068790
- Sponsor's protocol ID
- IndianaU 14563
- Status last verified
- Dec 2024
- First submitted
- 29 Aug 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 28Fr Versus 22Fr HoLEP, a Randomized Controlled Trial Indiana University School of Medicine, Department of Urology
- ClinicalTrials.gov ID
- NCT06068790
- Acronym / sponsor ID
- IndianaU 14563
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Current scope was available to perform procedure.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marcelino RiveraUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Oct 2023 (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.
The rationale for this study is to assess whether there is a difference in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
Detailed description
This study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, HoLEP performed with either 1) 22Fr sheath set or 2) 28Fr sheath set. After HoLEP, data will be analyzed using chi-square test for incontinence vs no incontinence between 22Fr and 28Fr groups at 1 week, 4 weeks and 12 weeks post operatively.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We hypothesize there will be lower rates of immediate urinary incontinence, and urethral stricture formation in patients undergoing HoLEP with smaller 22Fr sheaths compared to 28 Fr.
| Arm | Type | Receives |
|---|---|---|
| HoLEP surgery with 22Fr | Active comparator | Device: 22 French sized rigid sheathHoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr. |
| HoLEP surgery with 28Fr | Experimental | Device: 28 French sized rigid sheathHoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Age < 18 years old
- Existing stress or urge urinary incontinence
- Planned overnight admission or overnight catheterization
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 |
|---|---|---|
| HoLEP SurgeryHoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr. | Procedure or surgery | – |
| 28 French sized rigid sheathAlso: 28FrThe 28Fr is the standard of care sheath size used at this site. | Device | HoLEP surgery with 28Fr |
| 22 French sized rigid sheathAlso: 22FrThe 22Fr is the smaller, investigational sheath size to be used in this study. | Device | HoLEP surgery with 22Fr |
Primary outcome
Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
Time frame: M-ISI survey completed at 1,4,12 weeks
Measuring rates of immediate urinary incontinence or complications post-operation HoLEP using the Michigan Incontinence System Index (M-ISI) survey.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoLEP Surgery, 28 French sized rigid sheath and 22 French sized rigid sheath in people with Urinary Incontinence, run by Marcelino Rivera at 2 sites in United States.
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 0 inclusion and 3 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: withdrawn, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths. (time frame: M-ISI survey completed at 1,4,12 weeks). 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 9 Dec 2024.