Bowel Dysfunction and HoLEP Outcomes

NCT ID: NCT06688500

Last Updated: 2024-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-05

Study Completion Date

2025-10-31

Brief Summary

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The objective of this prospective study is to examine the correlation and effects of bowel dysfunction on outcomes for patients undergoing holmium laser enucleation of prostate (HoLEP) for lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH).The investigator hypothesizes that patients who have more bowel dysfunction based on higher severity scores on patient-reported validated questionnaires will experience more symptoms in the immediate post-operative period and may have slower recovery of urinary control. Assessment of pre, peri, and post-procedural bowel dysfunction via the Constipation Severity Score (CSS) and Vaizey Incontinence Questionnaire will aid the analysis.

Detailed Description

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Conditions

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Urologic Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Bowel function post Holmium Laser Enucleation of the Prostate

Observing post operative bowel functions among participants who have undergone a HoLEP procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Males18-89 undergoing HoLEP
* Able to read, understand, and complete patient questionnaires
* Willing to sign the informed consent form

Exclusion Criteria

* Patients with bowel diversion (colostomy, ileostomy)
* Patients with known neurogenic bowel
* Patients having concurrent ureteroscopy+/-laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at time of HoLEP
* Anticipated need for perineal urethrostomy at time of HoLEP
* Prior pelvic radiation or patients with history of bladder cancer with or without Bacillus Calmette-Guerin (BCG) therapy
* Patients who lack decisional capacity
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Amy Krambeck

Urologic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern Medicine

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Allaa Fadl-Alla, BS

Role: CONTACT

(312) 695-8146

Alyssa McDonald, MS

Role: CONTACT

(312) 695-8146

Facility Contacts

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Alyssa McDonald

Role: primary

312-695-8146

Other Identifiers

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STU00220105

Identifier Type: -

Identifier Source: org_study_id

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