Bowel Dysfunction and HoLEP Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Urologic Injuries
• Intervention / Treatment: Procedure: Bowel function post Holmium Laser Enucleation of the Prostate

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients 18-89 years old undergoing HoLEP

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in American Urologic Association Symptom Score (AUASS)	Identifying differences in AUASS scores pre-operatively versus post-operatively. An AUA symptom score of 0-7 is considered mild, 8-19 is moderate, and 20-35 is severe. This will be used in combination with the other measures to come up with total severity of overall condition.	3 months
Collecting preoperative bowel dysfunction scores via Constipation Severity Scale (CSS) and Vaizey Incontinence questionnaires	Identifying differences in CSS/Vaizey Incontinence questionnaires at pre-op 3- month clinic follow-up. Minimum score of 0 indicates perfect continence versus 24 which indicates total incontinence. This will be used in combination with the other measures to come up with total severity of overall condition.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change between pre-operative and post-operative bowel dysfunction scores and symptoms	Identifying changes in symptom management/resolve: post-op retention, time with catheter, gross hematuria, Urinary Tract Infection, Emergency Department visits and any other complications. This will be used in combination with the other measures to come up with total severity of overall condition.	6 months
Monitoring efficacy of procedure	Identifying changes with post void residual, Michigan Incontinence Score Index (MISI). With a score range of 0-32, identifying severity and total bother. This will be used in combination with the other measures to come up with total severity of overall condition.	1 year

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: STU00220105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No