A Randomized Controlled Trail of Uterosacral Ligament Suspension in the Treatment of Pelvic Organ Prolapse

Launched by LAN ZHU · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical methods for treating pelvic organ prolapse (POP) in women. POP is a condition where pelvic organs, like the uterus, drop down due to weak support tissues, which can cause discomfort and affect daily life. The trial aims to find out if a surgery that preserves the uterus (making it easier for women who want to keep their fertility) is just as effective as a surgery that removes it, especially for women with a specific issue called cervical elongation. By comparing these two approaches, the researchers hope to provide more choices for women dealing with POP.

To be eligible for the trial, participants must be women aged 18 or older, experiencing noticeable symptoms of uterine prolapse, and have a certain cervical length confirmed by an ultrasound. They should not have any serious underlying health conditions or previous pelvic surgeries that would affect the trial. Women who join the study can expect to undergo one of the two surgical options and will be monitored during their recovery. This research aims to improve treatment options for women with POP and may help guide future surgical decisions.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years with symptomatic stage II or higher uterine prolapse (C ≥ +1cm) and gynecological ultrasonography confirming cervical length ≥ 4cm. Concurrent anterior and/or posterior vaginal wall prolapse may be present.
• • Preoperative pelvic ultrasound and cervical screening show no abnormalities.
• • The patient does not have a desire for future fertility.
• • Willingness and ability to adhere to the follow-up treatment plan.
• • Competence to provide informed consent.
• Exclusion Criteria:
• • Suspected untreated lower genital tract tumor, accompanied by other uterine, ovarian, and cervical lesions requiring surgical intervention, indicating contraindication for uterine preservation.
• • Patients with a history of total hysterectomy/subtotal hysterectomy.
• • Patients who have previously undergone pelvic organ prolapse surgery or other pelvic floor surgeries.
• • Patients with contraindications for laparoscopic surgery, such as intestinal obstruction.
• • Patients with intestinal hernia.
• • Patients with gynecological and urinary tract infections, anticoagulant therapy, coagulation disorders, previous pelvic radiotherapy, as well as neurological or medical conditions affecting bladder and bowel function (such as multiple sclerosis, spinal cord injury, or residual neurological dysfunction caused by stroke), and patients with underlying conditions such as chronic pelvic pain, who are at higher risk for surgery.
• • Simultaneous anti-urinary incontinence surgery is required for this procedure.