Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 374
- 试验地点
- 18
- 主要终点
- Urinary Distress Inventory at 6 Months
研究概览
简要总结
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:
- to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and
- to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.
详细描述
Many women develop pelvic organ prolapse over the course of their lives. Pelvic organ prolapse is the downward descent of the pelvic organs (which include the uterus, bladder and bowel) into the vagina. Researchers estimate that between 7-10% of women will require surgery for prolapse sometime in their lifetime. Many will have more than one operation for the prolapse. Because this is such a common problem, the investigators in the Pelvic Floor Disorders Network strive to offer women the best treatment options. However, there were not enough carefully designed and conducted research studies to help guide them in this direction.
Women who are planning surgery for apical vaginal prolapse often experience bladder and bowel symptoms, as well as pressure and a bulge. These symptoms might include urinary leakage (urinary incontinence), urinary urgency (a sudden strong desire to urinate with fear that leakage may occur) or frequent urination, difficulty starting to urinate or perhaps a slow weak urinary stream, as well as accidental bowel leakage (fecal incontinence). After surgery, bladder and bowel symptoms may get better, get worse, or stay the same as before surgery. Sometimes new symptoms can start after surgery even if they weren't present before surgery.
The OPTIMAL study was designed to compare two commonly performed vaginal surgeries for pelvic organ prolapse. One is the sacrospinous ligament fixation, called SSLF for short. The other is the uterosacral ligament suspension, called ULS. Both surgeries involve attaching the top of the vagina, which has fallen down, to internal ligaments in the pelvis in order to resuspend the vagina and correct the prolapse.
The investigators were also interested in studying how the surgeries altered bladder and bowel symptoms. They had seen in other studies that behavioral and pelvic floor muscle therapy (PMT) is an effective therapy for stress and urge urinary incontinence, fecal incontinence, and other pelvic floor disorders. It is relatively easy to perform, and has rare side effects. They wondered if PMT around the time of surgery might further improve these symptoms.
The OPTIMAL study has two main purposes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Stage 2 to 4 prolapse
- •Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C > -TVL/2) [TVL stands for total vaginal length]
- •Vaginal bulge symptoms as indicated by an affirmative response to either questions on the Pelvic Floor Distress Inventory (PFDI)
- •Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure.
- •Stress incontinence symptoms as indicated by an affirmative response to the PFDI Stress incontinence subscale
- •Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months
- •A tension free vaginal tape (TVT) is planned to treat stress urinary incontinence.
- •A pelvic muscle training (PMT) visit can be performed at least 2 weeks and not more than 4 weeks before surgery.
- •Available for 24-months of follow-up.
- •Able to complete study assessments, per clinician judgment
- •Able and willing to provide written informed consent
排除标准
- •Contraindication to sacrospinous ligament fixation (SSLF), uterosacral vaginal vault ligament suspension (ULS), or TVT in the opinion of the treating surgeon.
- •History of previous surgery that included a SSLF or ULS. (Previous vaginal vault suspensions using other techniques or in which the previous technique is unknown are eligible.)
- •Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program.
- •History of previous synthetic sling procedure for stress incontinence.
- •Previous adverse reaction to synthetic mesh.
- •Urethral diverticulum, current or previous (i.e., repaired)
- •History of femoral to femoral bypass.
- •Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.
- •History of two inpatient hospitalizations for medical comorbidities in the previous 12 months.
- •Subject wishes to retain her uterus. [Both ULS and SLS include removal of the uterus, if not previously removed]
结局指标
主要结局
Urinary Distress Inventory at 6 Months
时间窗: 6 months
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Lower scores indicate better function / fewer symptoms.
Surgical Success
时间窗: 24 months
The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary.
Anatomic Failure
时间窗: 24 months
Anatomic failure is defined by one of the following: descent of the vaginal apex more than one-third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or re-treatment for prolapse.
次要结局
- Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months(Baseline and 24 months)
- Change From Baseline: Colorectal Anal Distress Inventory(Baseline and 24 months)
- Change From Baseline: Urinary Distress Inventory(Baseline and 24 months)
- Change From Baseline: Pelvic Organ Prolapse Distress Inventory(Baseline and 24 months)
- Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months(Baseline and 24 months)
- Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months(Baseline and 24 months)
- Urinary Impact Questionnaire Change From Baseline to 24 Months(Baseline and 24 months)
- Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months(Baseline and 24 months)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months(Baseline and 24 months)