Effects of bowel dysfunction on outcomes after prostate surgery
Bowel Dysfunction and HoLEP Outcomes
This study looks at how problems with bowel function affect recovery and results for men having surgery for prostate enlargement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | Male |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06688500 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how bowel dysfunction impacts the recovery and outcomes of patients undergoing holmium laser enucleation of the prostate (HoLEP) for benign prostatic hyperplasia (BPH). It will assess bowel function before, during, and after the procedure using validated questionnaires, specifically the Constipation Severity Score and the Vaizey Incontinence Questionnaire. The hypothesis is that greater bowel dysfunction correlates with more postoperative symptoms and slower recovery of urinary control.
Who should consider this trial
Good fit: Ideal candidates are males aged 18-89 who are scheduled for HoLEP and can complete patient questionnaires.
Not a fit: Patients with bowel diversions, neurogenic bowel, or those undergoing concurrent surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve postoperative care and recovery strategies for patients undergoing prostate surgery.
How similar studies have performed: While the specific correlation between bowel dysfunction and HoLEP outcomes is less explored, similar studies have shown that pre-existing conditions can significantly affect surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Northwestern Medicine — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Allaa Fadl-Alla, BS
- Email: allaa.fadlalla@northwestern.edu
- Phone: (312) 695-8146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.