Completed

NCT Number: NCT06688500

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.

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Key information

Conditions

Urologic Injuries

Age range

18 year–89 year

Sex eligibility

Male

Study type

Observational

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bowel function post Holmium Laser Enucleation of the Prostate

Procedure

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

Primary outcomes

Difference in American Urologic Association Symptom Score (AUASS)

Time frame: 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

Time frame: 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 outcomes

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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2026
First posted: Nov 14, 2024
Registry last updated: Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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