A Prospective，Multicenter Pilot Study to Compare Ischia Spinous Fascia Fixation Procedure With Modified Total Pelvic Floor Reconstruction Surgery For Pelvic Organ Prolapse Stage III
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- •Anatomical improvement according to POP-Q score.
研究概览
简要总结
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh are both developed in China for vaginal apex fixation, the former is native tissue repairs, and the latter is augmentation with mesh.
This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh for the treatment of pelvic organ prolapse stage III.
Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.
详细描述
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.
Vaginal procedures used for restoring the vaginal apex support include Ischia spinous fascia fixation procedure with native tissue and modified total pelvic floor reconstructive surgery with mesh. They are both developed and popular in China. Clinical practice showed that they were both safe, efficient and cost-effective. Recurrent rates of both procedures after 1 year follow-up were about 10%, and quality of life improved significantly from the baseline, while the.complications are different.
The purpose of this multicenter, prospective, and comparative study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic pelvic organ prolapse Stage III in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Candidates with symptomatic pelvic organ prolapse of POP-Q Stage III, suitable for surgical repair.
- •Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
- •Age ≥ 55 years.
- •Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
排除标准
- •Previous repair of pelvic organ prolapse involving insertion of mesh.
- •Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- •Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
- •Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
- •History of chemotherapy or pelvic radiation therapy.
- •Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
- •Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
- •Nursing or pregnant or intends future pregnancy.
- •Chronic cough not well-controlled.
- •In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
结局指标
主要结局
•Anatomical improvement according to POP-Q score.
时间窗: 3 years
次要结局
- •Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.(At discharge, an expected average of 5 days after operation.)
- •Pain score measured using Visual Analog Scale (VAS).(24 hours post surgery and at the 6-week visit)
- •Presence/absence of complications (composite score).(Up to 6 weeks.)
- •Change from baseline in PFIQ-7 scores.(1 year, 2 years and 3 years.)
- •In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)(1 year, 2 years and 3 years.)
- •Subject global impression assessed on a 5 point Likert scale(1 year, 2 years and 3 years.)
- •Presence/absence of complications (composite score)(Up to 3 years.)