Bowel Dysfunction and HoLEP Outcomes

Recruiting

• Conditions: Urologic Injuries

• Registration Number: NCT06688500
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-05
• Study First Submitted: 2024-06-26
• Primary Completion: 2024-09-20
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-12
• Last Update Submitted: 2024-11-12
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 126

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in American Urologic Association Symptom Score (AUASS)	3 months	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.
Collecting preoperative bowel dysfunction scores via Constipation Severity Scale (CSS) and Vaizey Incontinence questionnaires	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change between pre-operative and post-operative bowel dysfunction scores and symptoms	6 months	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.
Monitoring efficacy of procedure	1 year	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.

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States