NL-OMON54773招募中不适用
Clinical Study of Neuspera*s Implantable Sacral Nerve Stimulation (SNS) System in Patients with Symptoms of Urinary Urgency Incontinence (UUI) - SANS-UUI Study
euspera Medical Inc.0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Is willing and able to understand and has voluntarily signed and dated the
- •current approved informed consent.
- •2. Is male or female 22 years of age or older.
- •3. Has a Body Mass Index (BMI) between 18 and 40 kg/m^2.
- •4. Is a good surgical candidate and is capable of participating in all testing
- •and follow-up clinic visits associated with this clinical study and is capable
- •of independently using the system components as described in the Patient Manual.
- •5. Is ambulatory and able to use toilet without assistance.
- •6. Has a diagnosis of UUI for greater than or equal to 6 months prior to the
- •screening baseline visit date.
- •7. Has a typical residual bladder volume < 150 cc tested within 6 months prior
- •to the screening baseline visit date or is willing to have a test at screening
- •baseline visit.
- •8. Has urodynamic testing (uroflowmetry, cystometry, and pressure flow)
- •completed within 6 months prior to the screening baseline visit date or is
- •willing to have testing at screening baseline visit.
- •9. Has cystoscopy test completed within 6 months prior to the screening
- •baseline visit date or is willing to have a test at screening baseline visit.
- •10. Has failed or was not a candidate for more conservative treatment (e.g,.
- •pelvic floor exercise, biofeedback, behavioral modification).
- •11. Has failed, could not tolerate (stopped taking medication due to lack of
- •efficacy or intolerable side effects), or not a good candidate for (as
- •determined by treating physician) at least one (1) antimuscarinic or β3
- •adrenoceptor agonist medication.
- •12. Is willing and able to washout (at least five half-lives) from OAB
- •medications for a period determined appropriate based on type of OAB medication
- •prior to the baseline bladder diary and remain off OAB medications through the
- •12-month follow-up visit.
- •13. Has appropriate sacral anatomy as determined by sponsor*s and
- •investigator*s analysis of radiographic imaging. (The distance from the
- •surface of the skin in the prone and seated position to the bone edge of the S3
- •foramen must be within the capabilities of the system).
- •Bladder Diary Inclusion Criteria:
- •14. Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and
- •minimum of 1 UUI episodes per 24-hour period.
排除标准
- •1. Has a hemoglobin A1c of >8% or has diabetes mellitus with glucosuria
- •2. Has diabetic neuropathy.
- •3. Has interstitial cystitis or bladder pain syndrome as defined by either
- •American Urological Association (AUA) or European Association of Urology (EAU)
- •guidelines, chronic pelvic pain or recurrent symptomatic urinary tract
- •infections.
- •4. Has skin, orthopedic, neurological or hematological (bleeding disorder) or
- •anatomical limitations that could prevent successful placement of the
- •neurostimulator.
- •5. Has broken, blistered skin or compromised circulation in the area of the
- •neurostimulator implant.
- •6. Has neurogenic bladder dysfunction such as traumatic or atraumatic
- •myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular
- •7. Has documented urinary retention within 6 months prior to the screening
- •baseline visit date.
- •8. Has clinically significant bladder outlet obstruction.
- •9. Is currently undergoing or has previously undergone pelvic irradiation.
- •10. Is a subject with a mechanical obstruction such as benign prostatic
- •hypertrophy, urethral stricture or cancer.
- •11. Has current grade 3 or 4 pelvic organ prolapse including cystocele,
- •rectocele, , enterocele, procidentia or vaginal vault prolapse.
- •12. Has symptomatic urinary tract infection (UTI); the subject may be
- •considered for study enrollment if the subject is symptom-free after a full
- •course of treatment prior to beginning the baseline bladder diary. If an
- •asymptomatic bacteriuria is detected during the urinalysis performed at
- •screening, a subject may be enrolled without a waiting period relative to UTI
- •13. Has primary stress incontinence or mixed incontinence where the stress
- •component predominates or has been treated surgically for stress urinary
- •incontinence within 6 months prior to the screening baseline visit date.
- •14. Has received tibial nerve stimulation (TNS) in the past 3 months for the
- •treatment of overactive bladder or unwilling to stay off TNS therapy for
- •12-month period following implant.
- •15. Has received treatment of urinary symptoms with any botulinum neurotoxin
- •type-A (BoNT-A) agent in the past 12 months; (e.g. obotulinumtoxinA, Botox,®
- •abobotulinumtoxin A , Dysport,® IncobotulinumtoxinA, Xeomin®)
- •16. Is a woman who is pregnant or planning to become pregnant during this
- •clinical study or is a woman of child-bearing potential who is not using a
- •medically-acceptable method of birth control. Women of child-bearing potential
- •must undergo a pregnancy test, with clear negative result.
- •17. Has active substance abuse, including alcohol.
- •18. Has a known hypersensitivity or contraindication to procedural or
- •post-procedural medications which cannot be adequately managed medically.
- •19. Has a known hypersensitivity to Neuspera*s SNS System device components.
- •20. Has previously failed SNS therapy
- •21. Has active implantable medical devices such as neurostimulators, drug
- •pumps, pacemakers, or internal defibrillator since compatibility has not been
- •22. Has known needs for diathermy (shortwave, microwave, or therapeutic
- •ultrasound), and radiofrequency ablation, in the vicinity of the
- •neurostimulator since these procedures have not been evaluated.
- •23. Has a known need for therapeutic ultrasound in the area of the sacral nerve
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