Prehabilitation Program for Enlarged Prostate

Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a special pre-surgery program can help men with benign prostatic hyperplasia (BPH), a condition characterized by an enlarged prostate that can cause urinary issues. The program, called Comprehensive Prehabilitation Programming, includes exercises, mental health support, and educational resources to improve recovery after prostate surgery. Participants are divided into two groups: one receives standard care, while the other receives this comprehensive prehabilitation program. Men planning to undergo HoLEP surgery for BPH with a prostate size over 60 ml may be eligible, especially if they have internet access and their doctor’s permission to exercise. The goal is to determine if this program can safely enhance recovery and reduce urinary problems after surgery. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve recovery strategies for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation program is safe for men with BPH?

Research has shown that prehabilitation programs, like the one being tested, are generally safe and well-tolerated. Studies have found that exercise and mental health support before surgery can enhance recovery without causing serious side effects. For instance, these programs have successfully reduced issues like urinary incontinence in prostate cancer patients after surgery.

Overall, the physical activities in these programs are considered safe for managing symptoms of an enlarged prostate. Although specific data on the safety of this particular program is limited, similar prehabilitation approaches in other conditions suggest a low risk of negative effects. Participants can expect this program to be safe and potentially improve their recovery after prostate surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the comprehensive prehabilitation program for enlarged prostate because it combines standard surgical recommendations with a structured 12-week exercise and preparation regimen. Unlike the usual advice given before procedures like HoLEP, this program aims to improve patients' physical readiness and potentially enhance recovery outcomes. By focusing on prehabilitation, the program could offer benefits such as reduced surgical complications, quicker recovery times, and improved overall well-being, which are not typically addressed by standard pre-surgical care.

What evidence suggests that comprehensive prehabilitation programming is effective for benign prostatic hyperplasia?

Research has shown that prehabilitation programs, which include exercise and mental health support before surgery, aid recovery and reduce incontinence after prostate surgery. Studies on prostate cancer patients have found that these programs lead to better outcomes, such as quicker recovery of bladder control. Evidence from past research suggests that patients who participate in prehabilitation experience a better quality of life and feel less distress after surgery. In this trial, participants in the Comprehensive Prehabilitation Programming arm will receive such a program over 12 weeks. Although limited data exists on prehabilitation for surgeries like HoLEP for benign prostatic hyperplasia (BPH), the positive results seen in other prostate surgeries are encouraging.23467

Are You a Good Fit for This Trial?

This trial is for men with an enlarged prostate (BPH) who have chosen to have HoLEP surgery, have a prostate size over 60 ml, are cleared by their doctor to exercise, and can use the internet for online resources and questionnaires.

Inclusion Criteria

I have chosen to have HoLEP surgery for my enlarged prostate.
My prostate is estimated to be larger than 60 ml.
3. Have received permission to exercise from their primary care provider
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a comprehensive prehabilitation program including pelvic floor physiotherapy, informational resources, and mental health supports for at least 12 weeks

12 weeks
Every 3 weeks (in-person or virtual)

Surgery

Participants undergo Holmium Laser Enucleation of the Prostate (HoLEP)

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with assessments at multiple time points

52 weeks
4-, 12-, 26-, and 52-weeks post-surgery (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Comprehensive Prehabilitation Programming

Trial Overview

The study compares standard care before HoLEP surgery versus at least 12 weeks of prehabilitation. Prehabilitation includes pelvic floor exercises, educational materials, and mental health support. Participants are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Standard of CareActive Control1 Intervention
Group II: Comprehensive Prehabilitation ProgrammingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Citations

Feasibility and Utility of a Prehabilitation Program for Use ...

The objective of this study is to assess the safety and feasibility of prehabilitation programming prior to HoLEP procedures for men with BPH.

Prehabilitation Program for Enlarged Prostate

Holmium Laser Enucleation of the Prostate (HoLEP) is the gold standard in terms of surgical BPH management and is associated with a low risk for ...

Minimally invasive surgical therapies for benign prostatic ...

The largest cohort of patients reported in a multicenter, prospective trial showed improvement of both IPSS and quality of life scores (reduced by more than 50 ...

Comprehensive Prehabilitation Programming in Benign ...

In the setting of prostate cancer, exercise and mental health supports prior to surgery has been shown to improve incontinence and post-surgical ...

Trends and Perioperative Outcomes of Surgical Treatments ...

This study provides comprehensive real-world evidence on the perioperative outcomes and evolving trends of surgical treatments for benign prostatic hyperplasia ...

The Feasibility and Efficacy of Prehabilitation for Prostate ...

We conducted a 2-arm, pilot RCT to examine the efficacy of a comprehensive prehabilitation program versus CON on physical and psychosocial outcomes. This ...

Modern approaches to BPH management - PMC - NIH

TURP utilizes ubiquitous equipment and familiar techniques and, relative to medical management, demonstrates a median 14-point reduction in IPSS ...