Pivotal Study of Subcutaneous tibial nerve stimulation with eCoin for OAB with urinary urge incontinence Save

Date Added
October 9th, 2018
PRO Number
Pro00078760
Researcher
Eric Rovner

List of Studies


Profiles_link
Keywords
Bladder
Summary

Overactive bladder (OAB) is a clinical diagnosis characterized by the presence of bothersome urinary symptoms including urgency, frequency, nocturia, and urgency incontinence. Urinary incontinence is a prevalent condition that markedly impacts quality of life affecting both men and women. This investigation is a study of the Valencia Technologies eCoin system for people experiencing the accidental leakage of urine. If you choose to participate in this trial, you will have the eCoin device placed under the skin in your right or left leg near your ankle. The device will attempt to improve or restore normal control of your bladder by sending out electrical impulses to the tibial nerve. The electrical stimulation comes from a small device that is slightly larger than a nickel. The stimulation pulse intensity is adjusted to your highest comfortable level. An engineer will do this programming at the study center using an external controller. After activation, the implant automatically provides 30 minute stimulation sessions according to a fixed interval schedule. For the first 12 weeks of therapy, you will get your 30 minute session every third day. After 12 weeks, you will get your 30 minute sessions every fourth day. The time of day may vary from session to session. The duration of the study is 56 weeks.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

OUTCOMES OF PATIENTS WITH AUTOLOGUS MID-URETHRAL SLING AFTER FAILURE OF MID-URETHRAL MESH SLING Save

Date Added
June 29th, 2012
PRO Number
Pro00012059
Researcher
Eric Rovner

List of Studies


Profiles_link
Keywords
Urinary
Summary

Mid-urethral slings have been widely accepted as a treatment of choice for patients with stress urinary incontinence (SUI). Mid-Urethral sling surgery has been associated with good success rate and minimal morbidity.Minor complications are associated with these surgeries including bladder perforation, urethral injury or post operative complication such as de novo urgency and urge urinary incontinence, urinary retention or incomplete bladder emptying. Treatment approaches for complications included sling excision and urethral/bladder/ vaginal defect repair after sling intrusion or extrusion into these organs. Treatments for postoperative voiding dysfunction include clean intermittent catheterization, mid-urethral sling lysis, sling incision and formal urethrolysis. With urethrolysis, obstruction has been reported to be relieved in 65% to 93 with preservation of continence in 80% to 100% while the rate of SUI postoperative is 0 % to 19%.autologus fascial sling for relieve of obstruction with 54% of patients had no recurrence of their SUI [25]. On the other hand, there have been no published data on the use of autologus fascia lata pubovaginal sling to treat patient with recurrent SUI after incision of the mid-urethral mish slings. Urethral injection of bulking agent have been reported with 34% cure [26] and re-do mid urethral sling was reported to have only 53% success over 17 months of follow-up [9].
Our aim is to evaluate the subjective and objective outcomes of salvage treatment of failed mid-urethral mesh sling with sling incision, urethrolysis, autologus facial pubovaginal sling or other forms of diversion if needed. We also will evaluate if this procedure will help to improve in the quality of life of these patients.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
ude.csum@njiknej

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