Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence

Exercise Clinical Trial

Official title:

Efficacy of Personalized Extracorporeal Biofeedback Device for Pelvic Floor Muscle Training on Post-prostatectomy Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02485665
• Other study ID #: L-2015-298
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2015
• Last updated: November 16, 2015
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: Minyong Kang, M.D.,Ph.D.
• Phone: 82-31-787-6631
• Email: dr.minyong.kang[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence

Description:

• Post prostatectomy urinary incontinence (PPI) was common complication after radical prostatectomy among prostate cancer patients.

• The prevalence of post-prostatectomy urinary incontinence was reported at 87%.

• The pelvic floor muscle therapy (PFMT) using Kegel exercise was first methods to prevent PPI after prostatectomy.

• However, there was no standardized protocol of the PFMT and it was necessary of biofeedback to PFMT.

• Therefore, we hypothesis the efficacy of personalized device of PFMT with biofeedback among patients who underwent radical prostatectomy

• In this study, we evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Prostate cancer patients who underwent robotic radical prostatectomy

• Neurovascular saving at least one side

• Bladder neck reconstruction at prostatectomy

• Posterior reconstruction at prostatectomy

• Patients who have post-prostatectomy incontinence after Foley catheter removal

Exclusion Criteria:

• Patients who have not post-prostatectomy incontinence after Foley catheter removal

• Neurological deficits

• Anatomic deformities of pelvic bone

• Pelvic irradiation history

• History of other major urological procedures

• Complications influencing urinary incontinence

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Biofeedback
• Exercise
• Pelvic Floor
• Prostate Neoplasm
• Prostatectomy
• Prostatic Neoplasms
• Surgical Procedures, Robotic
• Urinary Incontinence

Intervention

Device:
• Extracorporeal biofeedback device (Any Kegel)
Prostate cancer patients of intervention group will received extracorporeal biofeedback device (Any Kegel) for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. Enrolled patients in intervention group should be performed PFME regularly, based on following protocols: total exercise time (10 minutes/day), intensity (1.2 kgf), tension duration (10 sec/ 1 contraction), total exercise number (4 times/day)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongam city	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Furun Medical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of urinary continence	weight of pad (g) by 24 hours pad test	postoperative 1 month	No
Secondary	Recovery of urinary continence	weight of pad (g) by 24 hours pad test	postoperative 3 month	No
Secondary	Recovery of urinary continence	number of pads for 24 hours	postoperative 1 and 3 months	No