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
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|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|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962569
|Contact: Joshua Lohri, DOemail@example.com|
|United States, West Virginia|
|Charleston Area Medical Center||Not yet recruiting|
|Charleston, West Virginia, United States, 25301|
|Contact: Joshua Lohri, DO 304-388-1965|
|Principal Investigator:||joshua lohri, DO||CAMC Health System|