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Behavioral Intervention

Preoperative PFPT for Urinary Retention

N/A
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: >=18 years of age
Sex: male sex assigned at birth (needs to have a prostate)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after surgery
Awards & highlights

Study Summary

This trial is being conducted to see if starting pelvic floor physical therapy before prostate surgery can help manage or prevent urinary incontinence (leaking) after the surgery. Pelvic floor physical therapy involves exercises

Who is the study for?
This trial is for individuals with an enlarged prostate experiencing symptoms like bedwetting, urinary retention, or incontinence. Participants should be scheduled for HoLEP surgery but haven't started pelvic floor physical therapy yet. Specific eligibility details are not provided.Check my eligibility
What is being tested?
The study tests if starting pelvic floor physical therapy before HoLEP surgery helps patients regain bladder control faster post-surgery compared to the traditional method of beginning therapy after surgery.See study design
What are the potential side effects?
Pelvic floor physical therapy is generally safe but may include temporary soreness or fatigue from exercises. There's no mention of other specific side effects related to this intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am a male with a prostate.
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I am scheduled for a HoLEP procedure due to prostate enlargement symptoms.

Timeline

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 continence
Secondary outcome measures
Post void residual
Uroflow
catheter duration
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Preoperative PFPTExperimental Treatment1 Intervention
This group of patients will be instructed to start pelvic floor physical therapy 1 month before surgery.
Group II: Postoperative PFPTActive Control1 Intervention
This group of patients will be instructed to start pelvic floor physical therapy after surgery (standard of care).

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,365,522 Total Patients Enrolled
4 Trials studying Urinary Retention
945 Patients Enrolled for Urinary Retention

Frequently Asked Questions

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

Is the process of enrolling participants still ongoing for this medical study?

"Indeed, as per the information accessible on clinicaltrials.gov, this research project is currently in need of eligible participants. The study's initial posting date was November 29th, 2023 and it was most recently updated on December 11th, 2023."

Answered by AI

How many individuals in total are participating in this clinical study?

"Indeed, as indicated on clinicaltrials.gov, this research study is actively seeking individuals to participate. The trial was originally posted on November 29th, 2023 and the most recent update was made on December 11th, 2023. The aim is to recruit a total of 36 participants from one location."

Answered by AI
~20 spots leftby Nov 2024