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Arm 1: Preoperative and postoperative pelvic floor physical therapy for Stress Incontinence

N/A

Waitlist Available

Led By Akhil Das, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult males who have lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) and considering/undergoing HoLEP for LUTS/BPH treatment at the University of California Irvine Medical Center.

English-speaker

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after surgery

Awards & highlights

Study Summary

This trial is looking at a surgical procedure called Holmium laser enucleation of the prostate (HoLEP) that is used to treat an enlarged prostate. The procedure involves removing part of the prostate

Who is the study for?

This trial is for men who are scheduled to undergo a surgical procedure called HoLEP to treat benign prostatic hyperplasia (BPH), which causes urinary issues. Participants should not have started any pelvic floor physical therapy before the study and must be willing to follow the assigned therapy schedule.Check my eligibility

What is being tested?

The trial tests if starting pelvic floor physical therapy before surgery can help patients recover faster from stress urinary incontinence after their prostate surgery, compared to starting it only after surgery as per current practice.See study design

What are the potential side effects?

Pelvic floor physical therapy is generally safe with minimal risk. Side effects may include temporary muscle soreness or fatigue due to exercises but typically do not involve serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man with urinary problems due to an enlarged prostate and considering/undergoing HoLEP.

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I speak English.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to urinary continence following catheter removal after HoLEP

Secondary outcome measures

American Urological Association Symptom Score

Catheter duration

Emergency room visits

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: Preoperative and postoperative pelvic floor physical therapyExperimental Treatment1 Intervention

Pelvic floor physical therapy (PFPT) will be initiated 1 month before surgery in patients randomized to Arm 1.

Group II: Arm 2: Postoperative pelvic floor physical therapy only.Active Control1 Intervention

At 1-3 days follow-up after surgery pelvic floor physical therapy (PFPT) will be initiated in the post-operative PFPT-only group as part of standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pelvic floor physical therapy

2016

N/A

~240

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

542 Previous Clinical Trials

1,921,929 Total Patients Enrolled

Akhil Das, MDPrincipal InvestigatorUniversity of California, Irvine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being enrolled in this clinical trial?

"Based on information available on clinicaltrials.gov, this particular study is currently not seeking participants. The trial was first posted on January 1st, 2024 and the most recent update was made on January 7th, 2024. However, it's worth noting that there are presently 284 other trials actively accepting enrollees at this time."

Answered by AI

Recent research and studies

Journal of Biomedical InformaticsJournal

Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support

Harris, Paul A., Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, and Jose G. Conde. 2009. “Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support”. Journal of Biomedical Informatics. Elsevier BV. doi:10.1016/j.jbi.2008.08.010.

clinicaltrials.govStudy

Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate

Akhil Das 2024. "Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06209307.

All > Benign Prostatic Hyperplasia > Bph