A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 5
- 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 is developed in China for vaginal apex fixation with native tissue.
This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure 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.
Ischia spinous fascia fixation procedure is developed in China. It is a transvaginal procedure used for restoring the vaginal apex support with native tissue. Clinical practice showed that it was safe, efficient and cost-effective. Recurrent rate after 1 year follow-up was about 10%, and quality of life improved significantly from the baseline.
The purpose of this multicenter, prospective study is to evaluate the effectiveness and safety of this procedure in the treatment of symptomatic pelvic organ prolapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Candidates with symptomatic pelvic organ prolapse of POP-Q Stage II or more, suitable for surgical repair.
- •Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
- •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.
- •BMI ≥
- •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, postoperative mortality, time of voiding recovery(At discharge, an expected average of 5 days after operation)