Prospective Randomized Evaluation of Peri-Ureteral and Intradetrusor Injection of Botulinum Toxin Type A for the Treatment of Ureteral Stent Related Pain and Irritative Voiding Symptoms
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Lower Urinary Tract Discomfort between pre-operative visit date and the stent removal date and two week follow up.
研究概览
简要总结
Botulinum toxin type A (Botox A) has shown great success in treating certain urologic conditions. A recent study has documented that Botox injected around the ureteral orifice (or place where the tube that connects the kidney to the bladder enters the bladder), during placement of a ureteral stent (small rubber tube that facilitate drainage of urine from the kidney to the bladder), resulted in a marked decline in the amount of stent pain experienced by patients. This finding was quite remarkable as stents are commonly used in many Urologic conditions, and these stents produce a remarkable degree of patient discomfort. Despite the great improvement in pain reduction, the irritative voiding symptoms [frequent need to void, urgency, burning with urination (dysuria) or nighttime voiding (nocturia)] were not ameliorated by the Botox injections in the ureteral orifice. However, it has already been well documented that in other clinical settings, administrations of Botox into the bladder muscle, has been shown to reduce these irritative symptoms.
The objective of the study is to determine if pain and irritative lower urinary tract symptoms related to ureteral stent placement will improve after the injection of Botox around the ureteral orifice and in the bladder itself.
详细描述
The objective of this prospective randomized single blinded controlled pilot study for patients undergoing unilateral ureteral stent insertion for benign urologic conditions is to determine if pain and irritative lower urinary tract symptoms (frequency, urgency, dysuria, nocturia) related to ureteral stent placement will improve after the injection of intradetrusor Botox (BTX) A.
The effects of BTX have been used for a number of medicinal purposes, including reducing wrinkles, migraine headaches, and excessive sweating. The use of BTX in urology and, more specifically, the lower urinary tract, is increasing. Botox is currently actively being used as a treatment strategy for use in Urologic conditions including neurogenic and non-neurogenic overactive bladder (OAB), detrusor sphincter dyssynergia, interstitial cystitis, urinary retention, and prostate disorders.
BTX serotypes. The seven distinct serotypes of BTX are designated A, B, C1, E, F, and G; BTX-A (Botox [Allergan, Inc., Irvine, Calif] and Dysport [Ipsen, Inc., Europe]) and BTX-B (Myobloc (Solstice Neurosciences, Inc., Malvern, Pa) are available commercially. Each serotype of botulinum toxin works by inhibiting the release of neurotransmitters, most notably acetylcholine, from the presynaptic neuromuscular junction (2). The result is inhibition of muscular contractions and paralysis.
In August 2011, the FDA recently approved the use of Botox injections for urinary incontinence secondary to neurogenic overactive bladder, a condition defined as unihibited bladder contractions causing voiding and creating symptoms of urinary frequency. The cause of the neurogenic overactive bladder in the patients studied was spinal cord injury and multiple sclerosis. Numerous prospective clinical trials have demonstrated a statistically significant difference of symptoms in patients receiving Botox injections into the overactive detrusor muscle compared to placebo groups. Botox injections were found to effectively relieve urinary incontinence and urinary frequency for a nine-month duration.
As part of standard clinical care, intravesical injection of Botox is currently used to ameliorate voiding symptoms in conditions where patients experience severe irritative symptoms and is currently seeking FDA approval for the treatment of overactive bladder in patients without a neurologic etiology. As a follow up study, we will evaluate the efficacy of combined periureteral and intravesical Botox injection for reduction of pain and irritative voiding
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients requiring unilateral ureteral stent insertion
- •Age > 18
- •Renal/ureteral stones (single or multiple)
- •Ureteral strictures
- •Surveillance ureterscopy
- •Willing and able to consent
- •Willing and able to complete study questionnaires/diaries
- •Willing to use CIC to empty the bladder at any time after study treatment if it is determined to be necessary by the investigator
排除标准
- •History of malignancy
- •Patients on medical therapy for benign prostatic hyperplasia (alpha blocker and/or 5alpha reductase inhibitor)
- •Patients taking muscarinic-receptor antagonists (Ex. detrol, ditropan etc.)
- •Patients who have an interstim sacral neuromodulator
- •History of urinary retention
- •Neurogenic or non-neurogenic detrusor overactivity
- •Pregnancy
- •Solitary kidney
- •Insulin dependent Diabetes Mellitus (Uncontrolled Diabetes (HbA1c > 8))
- •Neuropathy
- •History of transplant kidney
- •History of narcotic abuse or chronic pain
- •Anatomic bladder/ureteral abnormality
- •Previous cystectomy/urinary diversion
- •Conditions necessitating bilateral ureteral stents
- •History of Interstitial cystitis
- •Patients with a post-void residual volume of > 100ml
- •Patients with history of urinary retention
- •Patients with active urinary tract infection
- •Patients with history of chronic urinary tract infections
- •Patients with concomitant use of any botulinum toxin within 3 months or any urological use of botulinum toxin in the past
- •Patients with active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening
- •Patients with concurrent or previously uninvestigated hematuria within 6 months prior to screening. -Patients with investigated hematuria may have entered the study if urological/renal pathology had been ruled out to the satisfaction of the investigator
- •Patients with hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis Patients with a known allergy or sensitivity to any botulinum toxin preparation (including study medication preparation), anesthetics, or antibiotics used during the study
- •Patients with any medical condition that may have put them at increased risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
研究组 & 干预措施
Botox
The experimental group will include ureteral stent placement with three peri-ureteral injections of Botox A and fourteen site-specific intradetrusor injections of Botox A.
干预措施: Botox (Drug)
结局指标
主要结局
Change in Lower Urinary Tract Discomfort between pre-operative visit date and the stent removal date and two week follow up.
时间窗: At pre-operative visit (average of 7 days before stent placement), stent removal date (3-9 days after stent placement), and 2 week follow up (2 weeks after stent placement)
Lower urinary tract symptoms (frequency, urgency, nocturia, dysuria) - Ureteral Stent Symptom Questionnaire (USSQ). The USSQ has different sections that pertain to different domains of a patient's life. Therefore, a total score from each section will be measured individually as described by Joshi et al (15). The different domains of the USSQ include urinary symptoms, body pain, general health, work performance, sexual matters. The total scores from each of these sections will be compared individually. In addition, the total score for the entire questionnaire will also be assessed.
次要结局
- Post-operative pain(At pre-operative visit (average of 7 days before stent placement), stent removal date (3-9 days after stent placement), and 2 week follow up (2 weeks after stent placement))
- Post-surgical analgesic requirements(post-operative to follow up day (2 weeks))
研究者
Jaime Landman
Department of Urology Chair
University of California, Irvine