Early Activation of Artificial Urinary Sphincter

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Activation of Artificial Urinary Sphincter: A Pilot Study

Conditions
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Incontinence, Urinary

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Urinary Sphincter