Bowel Dysfunction and HoLEP Outcomes

NCT06688500 | Completed

• 1 other identifier: STU00220105
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urologic Injuries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change between pre-operative and post-operative bowel dysfunction scores and symptoms

  6 months

• Monitoring efficacy of procedure

  1 year

Interventions

Bowel function post Holmium Laser Enucleation of the Prostate PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients 18-89 years old undergoing HoLEP

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologic Surgeon

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: November 14, 2024
• Study Start: October 5, 2023
• Primary Completion: September 20, 2024
• Study Completion: April 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)