Clinical trial · Interventional
Pelvic Health and Physical Therapy to Improve Lives of Prostate Cancer Patients Undergoing Prostatectomy
Pelvic Health and Physical Therapy to Improve Lives of Prostate Cancer Patients
NCT04027270CI-TRIAL-00048870withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Covid
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- These individuals will receive standard of care for post operative recovery following a prostatectomy.
- type
- EXPERIMENTAL
- label
- Physical Therapy
- description
- These individuals will receive post operative physical therapy in addition to standard of care for post operative recovery following a prostatectomy.
- interventionNames
- Other: Physical Therapy
Primary outcomes (7)
- measure
- International Prostate Symptom Score Change
- timeFrame
- Preoperatively, 3 months post operatively, 9 months post operatively, 12 months post operatively, 18 months post operatively
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- RESULTNam 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
- RESULTWallis 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
- RESULTPedraza 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
- RESULTHung 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
- RESULTRibeiro 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