Evaluation of the Efficacy of Botulinum-A Toxin/DMSO Instillation in the Treatment of Women With Over Active Bladder (OAB) Syndrome and/or Urinary Urge Incontinence
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Incontinence Quality of Life (I-QoL) Score
研究概览
简要总结
The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.
详细描述
The primary objective of this study is to evaluate the efficacy of catheter-based instillation of a solution of Botox/DMSO as a novel method for treating women with overactive bladder (OAB) and secondary urinary incontinence who have failed oral pharmacologic therapy. This study will test the broad hypothesis that administration of Botox/DMSO instillations into the bladder with a urethral catheter can significantly improve symptoms and quality of life in patients with OAB when compared to DMSO installations alone. Explicitly, we hypothesize that scores on the validated Incontinence Quality of Life (I-QOL) questionnaire of women with OAB who receive Botox/DMSO instillation will be much improved at three-month follow-up compared to similar women receiving DMSO instillation alone. Our long-term goal is to offer women with detrusor hyperreflexia or OAB a less invasive alternative to surgery and an alternative to anticholinergic by mouth medications. In support of this effort, we are proposing a randomized, double-blind, placebo controlled clinical trial to be conducted in the Department of Urology at Mayo Clinic, Jacksonville, Florida.
Note: The study was terminated early in July of 2011 due to an extended medical absence of the Principal Investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient aged 18 years or older
- •No evidence of stress urinary incontinence on physical examination or urodynamics
- •Patients who have failed prior drug therapy for overactive bladder or detrusor hyperreflexia
- •Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency, urinary urge incontinence.
- •Patient who is mentally competent with the ability to understand and comply with the requirements of the study
- •Patient who agrees to be available for the follow-up evaluations as required by the protocol
- •Patient who has given signed informed consent
排除标准
- •Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures. (Patient with a single PVRU of >100 ml and followed by two consecutive PVRU measurements of <100 ml may be included in the study)
- •Patient with greater than vesicoureteral reflux grade 1, interstitial cystitis, genitourinary fistulae
- •Patient with pelvic organ prolapse stage III or IV, i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen (>+1), at straining
- •Patient with un-investigated hematuria
- •Patient with lower tract genitourinary malignancies
- •Patient on current medication for stress urinary incontinence, such as alpha-adrenergic agonists or duloxetine, within three weeks prior to completing the baseline Bladder Diary (estrogen therapy on a stable dose for at least two months prior to study start is allowed)
- •Patient with ongoing complications of prior anti-incontinence surgery
- •Patient who is pregnant, lactating, or planning to become pregnant within the study period
- •Patient who has received pelvic radiation
- •Patient with any condition, which could lead to significant postoperative complications, including current infection and uncontrolled diabetes.
- •Patient who is morbidly obese (defined as BMI > 40 Kg/m2)
- •Patient who is bedridden, institutionalized or in such physical condition that she cannot move to the closest bathroom without assistance from another person
- •Patient with current or acute urinary tract infection, including cystitis or urethritis. (Patient with such infections should be treated with antibiotics, with subsequent urinalysis tests confirming the absence of such infection before study inclusion)
- •Patient with any condition that would preclude treatment due to contraindications and/or warnings in the study product's labeling
- •Patient on immunomodulatory therapy (suppressive or stimulatory)
- •Patient with known lidocaine hypersensitivity or hypersensitivity to any anesthetics to be used during the treatment session/surgical procedure
- •Patient with a concurrent use of another study product within two weeks prior to study start, or who concurrently participate in any other clinical study
- •Any disease that in the opinion of the Investigator would make the patient unsuitable for the study
- •Patient with a life expectancy of less than 12 months
研究组 & 干预措施
Botox and DMSO instillation
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
干预措施: Botox Instillation (Drug)
Botox and DMSO instillation
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
干预措施: DMSO Instillation (Drug)
DMSO instillation
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
干预措施: DMSO Instillation (Drug)
结局指标
主要结局
Change in Incontinence Quality of Life (I-QoL) Score
时间窗: Baseline, 1 month, 3 months
The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from '1= Extremely' to '5= Not at all'. A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life.
次要结局
- Change in Incontinence Impact Questionnaire Short Form (IIQ-7)(baseline, 1 month, 3 months)
- Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)(baseline, 1 month, 3 months)
- Change in Urogenital Distress Inventory (UDI-6)(baseline, 1 month, 3 months)
- Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months(baseline, 1 month, 3 months)
- Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months(Baseline, 1 month, 3 months)