RECRUITING

Bowel Dysfunction and HoLEP Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Bowel Dysfunction and HoLEP Outcomes

Quick Facts

Study Start:2023-10-05
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06688500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males18-89 undergoing HoLEP
  2. * Able to read, understand, and complete patient questionnaires
  3. * Willing to sign the informed consent form
  1. * Patients with bowel diversion (colostomy, ileostomy)
  2. * Patients with known neurogenic bowel
  3. * Patients having concurrent ureteroscopy+/-laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at time of HoLEP
  4. * Anticipated need for perineal urethrostomy at time of HoLEP
  5. * Prior pelvic radiation or patients with history of bladder cancer with or without Bacillus Calmette-Guerin (BCG) therapy
  6. * Patients who lack decisional capacity

Contacts and Locations

Study Contact

Allaa Fadl-Alla, BS
CONTACT
(312) 695-8146
allaa.fadlalla@northwestern.edu
Alyssa McDonald, MS
CONTACT
(312) 695-8146
alyssa.mcdonald@northwestern.edu

Study Locations (Sites)

Northwestern Medicine
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-05
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2023-10-05
Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Urologic Injuries