NCT02485665

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

June 26, 2015

Last Update Submit

November 16, 2015

Conditions

Prostate NeoplasmProstatectomySurgical Procedures, RoboticUrinary IncontinenceBiofeedbackPelvic FloorExercise

Keywords

Prostate cancerRobot-assisted laparoscopic surgeryRadical prostatectomyPost-prostatectomy incontinencePelvic floor muscle exerciseExtracorporeal biofeedback device

Outcome Measures

Primary Outcomes (1)

  • Recovery of urinary continence

    weight of pad (g) by 24 hours pad test

    postoperative 1 month

Secondary Outcomes (2)

  • Recovery of urinary continence

    postoperative 3 month

  • Recovery of urinary continence

    postoperative 1 and 3 months

Study Arms (2)

Kegel exercise education

NO INTERVENTION

Prostate cancer patients of control group will received Kegel exercise education for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy.

Extracorporeal biofeedback device

EXPERIMENTAL

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.

Device: Extracorporeal biofeedback device (Any Kegel)

Interventions

Extracorporeal biofeedback device (Any Kegel)DEVICE

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)

Extracorporeal biofeedback device

Eligibility Criteria

Age20 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongam City, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (1)

  • Oh JJ, Kim JK, Lee H, Lee S, Jin Jeong S, Kyu Hong S, Eun Lee S, Byun SS. Effect of personalized extracorporeal biofeedback device for pelvic floor muscle training on urinary incontinence after robot-assisted radical prostatectomy: A randomized controlled trial. Neurourol Urodyn. 2020 Feb;39(2):674-681. doi: 10.1002/nau.24247. Epub 2019 Dec 2.

    PMID: 31793032DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary IncontinenceMotor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Seok-Soo Byun, M.D.,Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Minyong Kang, M.D.,Ph.D.

CONTACT

82-31-787-6631dr.minyong.kang@gmail.com

Dam-on Lee

CONTACT

82-31-787-7350r1453@snubh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2015

First Posted

June 30, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

July 1, 2016

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

KR(1)