Clinical trial NCT03962569: Early Activation of Artificial Urinary Sphincter
Official title: Early Activation of Artificial Urinary Sphincter: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Incontinence, Urinary
Keywords: Artificial Urinary Sphincter
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Incontinence Questionnaire Short form IIQ-7
timeFrame: pre-procedure, 3 week, 6 week, 3 month, 6 month, 1 year
measure: Improved quality of life scores (SF8 4 Week version)
timeFrame: pre-procedure, 3 week, 6 week, 3 month, 6 month, and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
Study officials:
affiliation: CAMC Health System
name: joshua lohri, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Parrillo, Lisa.;Wein, Alan. Post Prostatecomy Incontinence. Prostate Cancer (Second Edition), 2016
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.