Long-Term Effectiveness Of Sacrospinous Ligament Fixation vs Uterosacral Ligament Suspension With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training: Extended Operations & Pelvic Muscle Training Of Apical Support Loss Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 285
- 试验地点
- 7
- 主要终点
- Surgical Failure
研究概览
简要总结
Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.
We propose to test the following null hypotheses:
- There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery.
- The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.
详细描述
The goal of this long-term follow-up study is to extend the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period. The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study is a randomized trial designed 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 (SUI).
The OPTIMAL study includes a two-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. A further goal of E-OPTIMAL is to investigate a strategy for improving enrollment and retention in long-term studies of women undergoing surgery for pelvic organ prolapse and SUI, by randomizing subjects to two different recruitment methods.
The primary aims of this extension study are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and stress urinary incontinence:
- time to surgical failure;
- the long-term functional and health-related quality of life (QOL), adjusted for PMT treatment group;
- the annual and cumulative incidence, resolution, and persistence of pelvic floor symptoms (urinary, bowel, and prolapse), adjusted for PMT treatment group.
An additional primary aim (aim 4) is to determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention in E-OPTIMAL. We will utilize a conceptual framework that assesses three concepts (motivation, barriers and pragmatic issues) at two levels (study level and personal/individual level). This conceptual framework was developed following a review of the scant available literature on the topic, as well as during discussions with investigators who are experienced in recruiting and retaining participants in pelvic floor disorders studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Completion of the Year 2 OPTIMAL in-person visit
排除标准
- •Inability to provide informed consent.
- •Subjects who are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation) at the time of enrollment into E-OPTIMAL. Note: Subjects unable to return for annual visits are not excluded as they can participate in the telephone interview. However, every attempt will be made to encourage in-person participation.
- •Criteria for termination of participation:
- •(Due to evidence or likelihood that the subject can no longer consent for herself)
- •Subjects 75 years and older that fail the telephone mini-mental status examination. If the participant gets 5 or more of the 10 items "incorrect" the interviewer says "thank you very much for your time, that completes the interview for today." In other words, the interviewer in no way implies to the participant that they did not "pass" a test to continue. The interviewer contacts the appropriate site coordinator immediately after the interview to let them know of the outcome.
- •Subjects younger than 75 who appear to have cognitive deficits during the quality of life telephone interview will be administered the mini-mental status examination; those who fail will be excluded from further participation. (Proxy respondents will not be used.) Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
- •Subjects who become long-term residents of a skilled nursing facility.
- •Withdrawal of consent. Verbal assent will be obtained prior to each telephone interview and each in-person visit.
- •Note: Subjects that are unable to complete telephone interviews (for example, because of hearing loss) may complete the interview portion of the survey in person, either at the site or in the home.
研究组 & 干预措施
ULS
Uterosacral Ligament Suspension was one of the randomized surgical treatments in the OPTIMAL study
干预措施: ULS (Procedure)
Enrollment video arm
Arm of subjects that will be shown a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process.
干预措施: Enrollment video (Behavioral)
No video intervention arm
This group of subjects will not view a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process.
SSLF
Sacrospinous Ligament Fixation was one of the randomized surgical treatments in the OPTIMAL study.
干预措施: SSLF (Procedure)
PMT
Perioperative Behavioral Therapy/Pelvic Muscle Training was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.
干预措施: PMT (Behavioral)
Usual Care
No Perioperative Behavioral Therapy/Pelvic Muscle Training (i.e., usual care) was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.
干预措施: Usual Care (Other)
结局指标
主要结局
Surgical Failure
时间窗: 6 months and 1, 2, 3, 4, and 5 years
Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Recruitment Into E-OPTIMAL
时间窗: At 24 Months post OPTIMAL Treatment
Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL.
Retention in E-OPTIMAL
时间窗: 3, 4, and 5 Years Post OPTIMAL Treatment
Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study).
次要结局
- Bothersome Bulge Symptoms(6 months and 1, 2, 3, 4, and 5 years)
- Anatomic Failure(6 months and 1, 2, 3, 4, and 5 years)
- Retreatment for Pelvic Organ Prolapse(6 months and 1, 2, 3, 4, and 5 years)