Physical Therapy for Men 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: NCT02558946|
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : February 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Urinary Incontinence Pelvic Floor Physical Therapy||Behavioral: Pelvic Floor Muscle Physical Therapy Behavioral: Control Group||Not Applicable|
Goals of the present study will be to determine whether initiating pelvic floor muscle training preoperatively improves quality of life symptoms related specifically to urinary health following robot-assisted radical prostatectomy. Drawing definitive conclusions from past studies is challenging secondary to various inconsistencies including: variability of physical therapy intervention, poorly defined definitions of continence, as well as poorly defined quality of life measurements. Additionally, the vast majority of studies combined open and robotic prostatectomy increasing cohort heterogeneity and further blurring interpretation of results. The investigators' study will focus exclusively on patients undergoing robot-assisted radical prostatectomy. Standardized pelvic floor muscle therapy as well as clearly defined patient outcomes (ie: validated questionnaires) will be utilized to determine whether preoperative initiation of formal pelvic floor physical therapy can improve health-related quality of life following surgery.
In the era of robot-assisted radical prostatectomy does physical therapist initiated preoperative pelvic floor muscle training lessen the expected postoperative drop off in urinary related quality of life and/or improve patient's recovery of continence following surgery?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Perioperative Pelvic Floor Muscle Training May Improve Recovery of Continence in Men With Localized Prostate Cancer Undergoing Robot-Assisted Radical Prostatectomy|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||January 2019|
Active Comparator: Physical Therapy Treatment Group
Written and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit. The treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 7-10 days postoperative, and 4-8 weeks postoperative .
Behavioral: Pelvic Floor Muscle Physical Therapy
The treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 1 week postoperative, and 4-6 weeks postoperative and will be coordinated with surgeon appointments to minimize any inconvenience and travel time.
Active Comparator: Control Group
Written and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit.
Behavioral: Control Group
At the cancer consultation visit, subjects will be educated by the urologist or urology team member regarding surgical and postoperative expectations. At this time, subjects will be provided verbal instruction and written information regarding Kegel exercises. Subjects in the control group may decide the duration and frequency of home exercise performance.
- • Comparison of post-op EPIC scores in the two study groups [ Time Frame: 4 to 8 weeks post-op ]
- Return to continence following surgery [ Time Frame: Up to 12 months post-op ]
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): NCT02558946
|Contact: Kim Smoot||317-962-0869|
|United States, Indiana|
|IU Health Methodist Hospital and IU Health University Hospital||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Kim Smoot 317-962-0869|
|Principal Investigator: Ronald Boris, MD|