Intravesical OnabotulinumtoxinA Injection at the Time of Prolapse Surgery for the Treatment of Overactive Bladder Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference.
研究概览
简要总结
The purpose of the study will be to assess the efficacy and safety of bladder BOTOX® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.
详细描述
After being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. Those that qualify and choose to enroll will be randomized to receive either bladder BOTOX® or a placebo at the time of their surgery. Neither the patient nor the investigators will know if the patient receives BOTOX® or a placebo. Subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. Potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study.
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
- Triple (Participant, Care Provider, 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
- •Women scheduled for prolapse surgery
- •Bothersome OAB symptoms determined by a score of >20 on the OAB-q SF
- •Willingness to perform clean intermittent catheterization (CIC)
- •Ability to follow study instructions and complete required follow up
排除标准
- •Contraindications or allergy to Onabotulinumtoxin A
- •Intravesical Onabotulinumtoxin A within 3 months of the planned surgery date
- •Total body Onabotulinumtoxin A dose of ≥ 400 Units in the 3 months prior to the scheduled surgery date.
- •Inability or unwillingness to self-catheterize
- •Post-void residual ≥ 200mL
- •Neurogenic bladder or other neurological diseases that may cause voiding dysfunction
- •Concurrent use of other pharmacological treatment for the treatment of OAB symptoms at the time of prolapse repair surgery.
- •Females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study.
- •Inability to speak or read English
研究组 & 干预措施
Intravesical OnabotulinumtoxinA
The treatment group will receive 100 units of BOTOX® reconstituted in 10mL of injectable preservative-free normal saline at the time of cystoscopy. An injection cystoscopy needle will be set to 3mm and used to inject 0.5mL reconstituted OnabotulinumtoxinA at each injection site, approximately 1cm apart along the posterior bladder wall, for a total of 20 injection sites (4 rows of 5 injection sites). This will be the only treatment.
干预措施: OnabotulinumtoxinA 100 UNT (Drug)
Placebo
Subjects randomized to the placebo group will undergo the same procedure but will only receive 10mL of injectable preservative-free normal saline. This will be the only treatment.
干预措施: Injectable saline (Other)
结局指标
主要结局
Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference.
时间窗: From baseline (time of enrollment) to 6-12 weeks postoperatively
The OAB-q SF is a validated 6 item questionnaire that is scored and reported on a 0 to 100 point scale with increasing scores indicating more bother.
次要结局
- Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively.(At 6-12 weeks postoperatively)
- Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S).(From baseline (time of enrollment) to 6-12 weeks postoperatively)
- Urinary retention(From 2 weeks postoperatively to 12 weeks postoperatively)
- Urinary tract infection(From time of treatment to 12 weeks postoperative)
- Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12).(From baseline (time of enrollment) to 6-12 weeks postoperatively)