NCT03962569

Brief Summary

Urinary incontinence or loss of bladder control is a troublesome issue for all affected patients. The causes of urinary incontinence and its treatment options vary widely. A commonly encountered reason for urinary incontinence in men is related to treatment for prostate cancer. These treatment options can range from surgical removal of the prostate, external beam radiation therapy, and/or brachytherapy, the insertion of radioactive implants directly into the tissue. Mild cases of incontinence are responsive to more conservative measures, but moderate to severe cases often require placement of an artificial urinary sphincter. Typically, these devices are left deactivated for a period of 4- 6 weeks following implantation to allow swelling to subside before use. The investigators hypothesize that the device could be activated within an earlier timeframe without increasing the risk of complications. No studies to date have evaluated this; therefore the investigators plan to conduct a prospective study in which the investigators will activate the device 3 weeks after placement and monitor for complications.

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
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

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

May 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

May 17, 2019

Last Update Submit

August 7, 2019

Conditions

Incontinence, Urinary

Keywords

Artificial Urinary Sphincter

Outcome Measures

Primary Outcomes (2)

  • Incontinence Questionnaire Short form IIQ-7

    patients with earlier AUS activation will have percentage of interference changed scores on the Urinary incontinence survey beginning at 6 week mark and increasing there after until 1 year. Survey includes 7 questions with results values ranging from '0' for no interference up to '3' for greatly interfering in the patient's activities, relationships, and feelings. Higher percentage scores indicate more interference in these activities.

    pre-procedure, 3 week, 6 week, 3 month, 6 month, 1 year

  • Improved quality of life scores (SF8 4 Week version)

    patients with earlier AUS activation will have changed SF8 scores beginning at 6 week mark and increasing there after due to early activation. Higher scores indicate better self reported quality of life.

    pre-procedure, 3 week, 6 week, 3 month, 6 month, and 1 year

Eligibility Criteria

Age18 Years - 99 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales with moderate to severe urinary incontinence
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All male patients with moderate to severe urinary incontinence who have been treated for prostate cancer (radical prostatectomy, External Beam Radiation therapy or brachytherapy, or Incontinence related to trans urethral resection of the prostate (TURP) or simple prostatectomy undergoing artificial urinary sphincter placement at Charleston Area Medical Center by Dr. Joshua Lohri, D.O.

You may qualify if:

  • All patients undergoing artificial urinary sphincter (AUS) placement by single surgeon, Joshua Lohri, DO.

You may not qualify if:

  • Any patient who has previously undergone artificial urinary sphincter placement and presents for revision or additional cuff placement.
  • Any patient who is undergoing combined artificial urinary sphincter and inflatable penile prosthesis placement.
  • Any patient who is a poor candidate for early activation due to poor condition at presentation or signs of infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charleston Area Medical Center

Charleston, West Virginia, 25301, United States

RECRUITING

Related Publications (9)

  • Wolin KY, Luly J, Sutcliffe S, Andriole GL, Kibel AS. Risk of urinary incontinence following prostatectomy: the role of physical activity and obesity. J Urol. 2010 Feb;183(2):629-33. doi: 10.1016/j.juro.2009.09.082. Epub 2009 Dec 16.

    PMID: 20018324BACKGROUND

  • Viers BR, Linder BJ, Rivera ME, Rangel LJ, Ziegelmann MJ, Elliott DS. Long-Term Quality of Life and Functional Outcomes among Primary and Secondary Artificial Urinary Sphincter Implantations in Men with Stress Urinary Incontinence. J Urol. 2016 Sep;196(3):838-43. doi: 10.1016/j.juro.2016.03.076. Epub 2016 Mar 17.

    PMID: 26997310BACKGROUND

  • Parrillo, Lisa.;Wein, Alan. Post Prostatecomy Incontinence. Prostate Cancer (Second Edition), 2016

    BACKGROUND

  • Linder BJ, Piotrowski JT, Ziegelmann MJ, Rivera ME, Rangel LJ, Elliott DS. Perioperative Complications following Artificial Urinary Sphincter Placement. J Urol. 2015 Sep;194(3):716-20. doi: 10.1016/j.juro.2015.02.2945. Epub 2015 Mar 14.

    PMID: 25776908BACKGROUND

  • James MH, McCammon KA. Artificial urinary sphincter for post-prostatectomy incontinence: a review. Int J Urol. 2014 Jun;21(6):536-43. doi: 10.1111/iju.12392. Epub 2014 Feb 16.

    PMID: 24528387BACKGROUND

  • Lai HH, Hsu EI, Teh BS, Butler EB, Boone TB. 13 years of experience with artificial urinary sphincter implantation at Baylor College of Medicine. J Urol. 2007 Mar;177(3):1021-5. doi: 10.1016/j.juro.2006.10.062.

    PMID: 17296403BACKGROUND

  • John Ware, Jr, Ph.D., Mark Kosinski, M.A., James E. Dewey, Ph.D., Barbara Gandek, M.S. How to score & interpret single item health status measures. Manual for users of SF8, Lincdn, RI. Quality Metric Incorporated, 2001. 1998-2001.

    BACKGROUND

  • Roberts B, Browne J, Ocaka KF, Oyok T, Sondorp E. The reliability and validity of the SF-8 with a conflict-affected population in northern Uganda. Health Qual Life Outcomes. 2008 Dec 2;6:108. doi: 10.1186/1477-7525-6-108.

    PMID: 19055716BACKGROUND

  • Moore KN, Jensen L. Testing of the Incontinence Impact Questionnaire (IIQ-7) with men after radical prostatectomy. J Wound Ostomy Continence Nurs. 2000 Nov;27(6):304-12. doi: 10.1067/mjw.2000.110623.

    PMID: 11096410BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • joshua lohri, DO

    CAMC Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Lohri, DO

CONTACT

304-388-1965joshua.lohri@camc.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 24, 2019

Study Start

August 1, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2023

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

US(1)