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Pelvic Health and Physical Therapy to Improve Lives of Prostate Cancer Patients Undergoing Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04027270
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Y Stone, University of Missouri-Columbia

Brief Summary:
Patients will be randomized into standard of care or receiving pre and post operative physical therapy intervention following prostatectomy. Outcome measures will be gathered to assess impact of physical therapy on function and quality of life.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Physical Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Randomization into treatment and standard of care groups. Treatment group will receive physical therapy in addition to standard of care treatment.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pelvic Health and Physical Therapy to Improve Lives of Prostate Cancer Patients
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care
These individuals will receive standard of care for post operative recovery following a prostatectomy.
Experimental: Physical Therapy
These individuals will receive post operative physical therapy in addition to standard of care for post operative recovery following a prostatectomy.
Other: Physical Therapy
Physical therapy 1-2 times per week for 3 months postoperatively to include lifestyle education, manual therapy, and exercise.




Primary Outcome Measures :
  1. International Prostate Symptom Score Change [ Time Frame: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively ]
    Change in IPPS from preoperative through to 18 months post operatively, assessed at intervals

  2. International Index of Erectile Function Change [ Time Frame: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively ]
    Change in IIEF from preoperative through to 18 months post operatively, assessed at intervals

  3. National Institute of Health Chronic Prostatitis Symptom Index Change [ Time Frame: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively ]
    Change in NIH-CPSI from preoperative through to 18 months post operatively, assessed at intervals

  4. Pain Visual Analog Scale Change [ Time Frame: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively ]
    Change in Pain VAS from preoperative through to 18 months post operatively, assessed at intervals

  5. Beck's Depression Index Change [ Time Frame: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively ]
    Change in BDI from preoperative through to 18 months post operatively, assessed at intervals

  6. Bristol Stool Scale Change [ Time Frame: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively ]
    Change in Bristol Stool Scale from preoperative through to 18 months post operatively, assessed at intervals

  7. Pelvic Floor Strength Test Change [ Time Frame: Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively ]
    Change in strength from preoperative through to 18 months post operatively, assessed at intervals



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Age greater than or equal to 18 years
  • Men who have prostate cancer (regardless of grade or metastasis)
  • Robotic assisted RALP performed by Urologic Oncologist
  • Fluent in speaking and understanding English

Exclusion Criteria:

  • - Inability to obtain written informed consent
  • Atrioventricular conduction blocks
  • CV instability and concomitant use of alpha agonists or beta blockers
  • Recent myocardial infarction (≤ 6 months ago)
  • Cardiac arrhythmia disorders
  • Stokes-Adams syndrome
  • Wolff-Parkinson-White syndrome
  • Seizure disorders
  • Liver failure or hepatic dysfunction
  • Significant renal disease with a serum creatinine ≥ 2 mg/dl
  • A family history of malignant hyperthermia
  • Current abuse of opioids or documented history of opioid abuse
  • Unavailability for reliable transportation
  • Combined surgical cases that include robotic prostatectomy
  • Non-fluent in English speaking and understanding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027270


Locations
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United States, Missouri
Jennifer Stone
Columbia, Missouri, United States, 65202
Sponsors and Collaborators
University of Missouri-Columbia

Publications of Results:
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Responsible Party: Jennifer Y Stone, Manager, Clinical Rehabilitative Services, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04027270     History of Changes
Other Study ID Numbers: PTProstatectomy1
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases