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

NCT04027270 | Withdrawn

• 1 other identifier: 2015982
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (7)

• International Prostate Symptom Score Change

  Change in IPPS from preoperative through to 18 months post operatively, assessed at intervals

  Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

• International Index of Erectile Function Change

  Change in IIEF from preoperative through to 18 months post operatively, assessed at intervals

  Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

• National Institute of Health Chronic Prostatitis Symptom Index Change

  Change in NIH-CPSI from preoperative through to 18 months post operatively, assessed at intervals

  Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

• Pain Visual Analog Scale Change

  Change in Pain VAS from preoperative through to 18 months post operatively, assessed at intervals

  Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

• Beck's Depression Index Change

  Change in BDI from preoperative through to 18 months post operatively, assessed at intervals

  Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

• Bristol Stool Scale Change

  Change in Bristol Stool Scale from preoperative through to 18 months post operatively, assessed at intervals

  Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

• Pelvic Floor Strength Test Change

  Change in strength from preoperative through to 18 months post operatively, assessed at intervals

  Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively

Study Arms (2)

Standard of Care

NO INTERVENTION

These individuals will receive standard of care for post operative recovery following a prostatectomy.

Physical Therapy

EXPERIMENTAL

These individuals will receive post operative physical therapy in addition to standard of care for post operative recovery following a prostatectomy.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

Physical therapy 1-2 times per week for 3 months postoperatively to include lifestyle education, manual therapy, and exercise.

Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Jennifer Stone

Columbia, Missouri, 65202, United States

Location

Related Publications (5)

• Nam RK, Cheung P, Herschorn S, Saskin R, Su J, Klotz LH, Chang M, Kulkarni GS, Lee Y, Kodama RT, Narod SA. Incidence of complications other than urinary incontinence or erectile dysfunction after radical prostatectomy or radiotherapy for prostate cancer: a population-based cohort study. Lancet Oncol. 2014 Feb;15(2):223-31. doi: 10.1016/S1470-2045(13)70606-5. Epub 2014 Jan 17.

  PMID: 24440474 RESULT

• Wallis CJ, Herschorn S, Saskin R, Su J, Klotz LH, Chang M, Kulkarni GS, Lee Y, Kodama RT, Narod SA, Nam RK. Complications after radical prostatectomy or radiotherapy for prostate cancer: results of a population-based, propensity score-matched analysis. Urology. 2015 Mar;85(3):621-7. doi: 10.1016/j.urology.2014.11.037.

  PMID: 25733275 RESULT

• Pedraza R, Nieto J, Ibarra S, Haas EM. Pelvic muscle rehabilitation: a standardized protocol for pelvic floor dysfunction. Adv Urol. 2014;2014:487436. doi: 10.1155/2014/487436. Epub 2014 Jun 11.

  PMID: 25006337 RESULT

• Hung HC, Hsiao SM, Chih SY, Lin HH, Tsauo JY. An alternative intervention for urinary incontinence: retraining diaphragmatic, deep abdominal and pelvic floor muscle coordinated function. Man Ther. 2010 Jun;15(3):273-9. doi: 10.1016/j.math.2010.01.008. Epub 2010 Feb 24.

  PMID: 20185357 RESULT

• Ribeiro LH, Prota C, Gomes CM, de Bessa J Jr, Boldarine MP, Dall'Oglio MF, Bruschini H, Srougi M. Long-term effect of early postoperative pelvic floor biofeedback on continence in men undergoing radical prostatectomy: a prospective, randomized, controlled trial. J Urol. 2010 Sep;184(3):1034-9. doi: 10.1016/j.juro.2010.05.040.

  PMID: 20643454 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager, Clinical Rehabilitative Services

Model Details: Randomization into treatment and standard of care groups. Treatment group will receive physical therapy in addition to standard of care treatment.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 19, 2019
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)