Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction
2019年2月7日 更新者：Weill Medical College of Cornell University
Randomized Double-blind Placebo Controlled Trial of Intradetrusor Injections of Botox for the Treatment of Refractory Overactive Bladder Secondary to Benign Prostatic Obstruction-BTX0621
This is a prospective, randomized, double-blind study comparing intravesical injection of BOTOX to placebo.
Study subjects will be randomized (1:1 ratio) to one of the following treatment groups:
調査の概要
詳細な説明
Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0), subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study duration is approximately 284 days and consists of a Screening Visit (Day -7 to -14), a Treatment/Randomization Visit (Visit 2, Day 0), and Follow-up Visits at 7, 30, 90, 180, and 270 Days. Telephone Follow-ups will be made 3 days following the injection cycle.
Subjects demonstrating an insufficient response to treatment may receive an open-label injection cycle of BOTOX (200U) at Day 90. Subjects receiving this injection will re-commence Follow-up Visits and be followed for an additional 270 days.
研究の種類
介入
入学 (実際)
30
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New York
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New York、New York、アメリカ、10065
- Weill Cornell Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～90年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
Inclusion Criteria:
- Male outpatients of any race, between 40 and 90 years of age.
- Clinical signs and symptoms of frequency (>=8 micturitions/day) and urgency (>=2 episodes/day).
- Urodynamic history consistent with OAB that developed in conjunction with BPO and that persists for at least 3 months post TURP or PVP, RRP or other obstruction relieving procedure.
- OAB inadequately controlled with anticholinergic medications, as per Investigator opinion.
- Qmax >12mL/s with a voided volume of >125mL.
- IPSS >12, with IPSS QoL >3 at study Visit 1.
- Willing to use clean intermittent catheterization (CIC) to empty the bladder or is willing to have an indwelling catheter, if necessary following study treatment.
- Able to understand the requirements of the study, including completing questionnaires and signing Informed Consent/HIPAA.
Exclusion Criteria:
- Known history of interstitial cystitis, uninvestigated hematuria, bladder outlet obstruction due to vesical neck contracture, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
- Known history of clinically significant cardiovascular disease, cerebrovascular disease, or arrhythmia.
- History of spinal cord injury or multiple sclerosis, or other neurological disease which may be contributing to OAB.
- Known history of hydronephrosis.
- Current indwelling catheter, or removal of chronic catheter <1 month prior to study entry.
- Non-compliance with wash-out periods for prohibited medications/therapies (Supplement I).
- Evidence of Urinary Tract Infection according to local standard of care.
- Serum PSA of >10ng/mL.
- 24 hour total volume voided >3000 mL of urine. [As determined by completion of a patient bladder diary during the screening period]
- Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
- Allergy or sensitivity to any component of BOTOX® (Section 5.2).
- Known uncontrolled systemic disease.
- Evidence of recent alcohol/drug abuse.
- Subjects who, in the opinion of the Investigator, have a significant condition that puts them at significant risk, may confound study results, or interfere with study participation.
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Botox
200U onabotulinumtoxinA (botox)
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Botox injection
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プラセボコンパレーター：Placebo
200U Saline
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プラセボ注射
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Urinary Frequency
時間枠：From Baseline to Day 270
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This is the measure of urinary frequency at baseline for those in the placebo and botox arms to day 270
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From Baseline to Day 270
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Urgency
時間枠：From Baseline to Day 270
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This measured the degree of urinary urgency using a 3-day voiding diary.
Patients were assessed for the number of urgency episodes they had by answering yes or no.
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From Baseline to Day 270
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Quality of Life (QoL)
時間枠：From Baseline to Day 270
|
Quality of Life (QoL) is from the ICIQ-QAB (international Consultation of Incontinence Overactive Bladder) Questionnaire.
It is scored 25-160 and those with higher scores have higher impact on quality of life.
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From Baseline to Day 270
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International Consultation on Incontinence Questionnaire (ICIQ)
時間枠：From Baseline to Day 270
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ICIQ is a brief validated instrument that is comprehensive for the assessment of incontinence and measures frequency, severity and impact on quality of life.
There are a total of 23 items.
The overall score ranges from 1-84 with greater values indicating increased symptom severity.
Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient.
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From Baseline to Day 270
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Postvoid Residual Volume (PVR)
時間枠：From Baseline to Day 270
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Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.
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From Baseline to Day 270
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Maximum Flow Rate (Qmax)
時間枠：From Baseline to Day 270
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Qmax is the the maximum recorded flow rate
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From Baseline to Day 270
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International Prostate Symptom Score (IPSS)
時間枠：From Baseline to Day 270
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International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH.
The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia.
Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic)
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From Baseline to Day 270
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Alexis Te、Weill Medical College of Cornell University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年6月1日
一次修了 (実際)
2011年6月1日
研究の完了 (実際)
2012年11月13日
試験登録日
最初に提出
2010年6月22日
QC基準を満たした最初の提出物
2010年10月12日
最初の投稿 (見積もり)
2010年10月14日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月26日
QC基準を満たした最後の更新が送信されました
2019年2月7日
最終確認日
2019年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。