Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

NCT06068790 | Withdrawn FDA Device

• 1 other identifier: IndianaU 14563
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  M-ISI survey completed at 1,4,12 weeks

Study Arms (2)

HoLEP surgery with 22Fr

ACTIVE COMPARATOR

HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.

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.

Device: 28 French sized rigid sheath

Interventions

HoLEP Surgery PROCEDURE

HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.

28 French sized rigid sheath DEVICE

The 28Fr is the standard of care sheath size used at this site.

Also known as: 28Fr

HoLEP surgery with 28Fr

22 French sized rigid sheath DEVICE

The 22Fr is the smaller, investigational sheath size to be used in this study.

Also known as: 22Fr

HoLEP surgery with 22Fr

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age \< 18 years old
• Existing stress or urge urinary incontinence
• Planned overnight admission or overnight catheterization

Sponsors & Collaborators

• Marcelino Rivera: lead
• Indiana University: collaborator

Study Sites (2)

Indiana University Health Physicians Urology

Indianapolis, Indiana, 46202, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Urology

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: October 5, 2023
• Study Start: August 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

US (2)