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Bowel Dysfunction and HoLEP Outcomes

Bowel Dysfunction and HoLEP Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06688500
Enrollment
120
Registered
2024-11-14
Start date
2023-10-05
Completion date
2026-04-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urologic Injuries

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.

Interventions

PROCEDUREBowel function post Holmium Laser Enucleation of the Prostate

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

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in American Urologic Association Symptom Score (AUASS)3 monthsIdentifying 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 questionnaires3 monthsIdentifying 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

MeasureTime frameDescription
Change between pre-operative and post-operative bowel dysfunction scores and symptoms6 monthsIdentifying 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 procedure1 yearIdentifying 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026