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Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

Sponsor
Marcelino Rivera (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06068790
Collaborator
Indiana University (Other)
126
Enrollment
2
Locations
1
Arm
23
Anticipated Duration (Months)
63
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: HoLEP Surgery
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Masking 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
Primary Purpose:
Health Services Research
Official Title:
28Fr Versus 22Fr HoLEP, A Randomized Controlled Trial Indiana University School of Medicine, Department of Urology
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: HoLEP surgery

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

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

Outcome Measures

Primary Outcome Measures

  1. Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria:• Age >18 years old Undergoing HoLEP for benign prostatic enlargement Eligible for same day catheter removal

Exclusion Criteria:

  • Age < 18 years old

  • Existing stress or urge urinary incontinence

  • Planned overnight admission or overnight catheterization

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University Health Physicians Urology Indianapolis Indiana United States 46202
2 Indiana University Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Marcelino Rivera
  • Indiana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marcelino Rivera, Assistant Professor of Urology, Indiana University School of Medicine
ClinicalTrials.gov Identifier:
NCT06068790
Other Study ID Numbers:
  • IndianaU 14563
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Incontinence

Study Results

No Results Posted as of Oct 5, 2023