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Early Activation of Artificial Urinary Sphincter (WV_AUS)

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ClinicalTrials.gov Identifier: NCT03962569
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Lohri, CAMC Health System

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.

Condition or disease
Incontinence, Urinary

Detailed Description:

This study is a single institute prospective study with patients undergoing artificial urinary sphincter placement by the operating surgeon, Dr. Joshua Lohri at Charleston Area Medical Center in Charleston, WV. Any 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. will be offered the chance to participate in this study. The investigators aim to enroll 25 patients, which is anticipate to be accrued within 3 years from the start of the study. Patients will be excluded if: 1) the have previously undergone artificial urinary sphincter placement and presents for revision or additional cuff placement, 2) has had combined artificial urinary sphincter and inflatable penile prosthesis placemen and 3) are a poor candidate for early activation due to poor condition at presentation or signs of infection.

All patients agreeing to participate will have the urinary sphincter activated 3 weeks after surgery. If there are patients that later choose not to have early activation or are found to be poor candidates for three week activation based upon post op exam, the investigator will proceed with activation at a 4-6 week time period. While there is no comparison group in the study, patient satisfaction and adverse events for study patients will be compared to historical literature.

Before the procedure is performed all eligible patients will be informed about the study at the regularly scheduled pre-operative office visit and if the patient would like to participate will be offered to sign the consent document. The participant will receive a copy of the signed consent form and be asked to an SF-8 quality of life survey and Incontinence Impact Questionnaire. Once consented, the patient will undergo the procedure without any changes to the normal routine. The patient's device will be deactivated at the conclusion of the procedure.

After the procedure, the patient will be discharged post-operatively (same day) and follow-up will be arranged in 3 weeks to activate the device (up to 3 weeks and 3 days after the procedure) which includes a post-operative evaluation of incisions, degree of bruising, tissue induration, tenderness and accessibility of the pump. If these factors are acceptable and pump mechanics are normal, the artificial sphincter will be activated and the patient will be educated on its proper use. Additional follow up will include the regular 6 week visit, a visit at 3 months, and then every 6 months for a total of 1 year unless issues arise that necessitates deviation. At each visit, patients will complete the Incontinence Impact Questionnaire and the SF-8 quality of life survey.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Activation of Artificial Urinary Sphincter: A Pilot Study
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2023



Primary Outcome Measures :
  1. Incontinence Questionnaire Short form IIQ-7 [ Time Frame: pre-procedure, 3 week, 6 week, 3 month, 6 month, 1 year ]
    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.

  2. Improved quality of life scores (SF8 4 Week version) [ Time Frame: pre-procedure, 3 week, 6 week, 3 month, 6 month, and 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males with moderate to severe urinary incontinence
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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): NCT03962569


Contacts
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Contact: Joshua Lohri, DO 304-388-1965 joshua.lohri@camc.org

Locations
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United States, West Virginia
Charleston Area Medical Center Not yet recruiting
Charleston, West Virginia, United States, 25301
Contact: Joshua Lohri, DO    304-388-1965      
Sponsors and Collaborators
CAMC Health System
Investigators
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Principal Investigator: joshua lohri, DO CAMC Health System
  Study Documents (Full-Text)

Documents provided by Joshua Lohri, CAMC Health System:

Additional Information:
Publications:
Parrillo, Lisa.;Wein, Alan. Post Prostatecomy Incontinence. Prostate Cancer (Second Edition), 2016
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.

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Responsible Party: Joshua Lohri, Principal Investigator, CAMC Health System
ClinicalTrials.gov Identifier: NCT03962569     History of Changes
Other Study ID Numbers: 19-556
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Must get approval from CAMC Privacy Office prior to sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joshua Lohri, CAMC Health System:
Artificial Urinary Sphincter

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders