A Randomized Controlled Trial of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse

Launched by LAN ZHU · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two surgical procedures for treating pelvic organ prolapse, which is a condition where pelvic organs like the bladder or uterus drop down due to weakened support tissues. The trial compares a newer technique called modified ischial spinous fascia fixation (modified ISFF) with the traditional method called sacrospinous ligament fixation (SSLF). Both aim to provide better support for the vaginal wall and improve the quality of life for women experiencing symptoms of this condition. Researchers want to see if the new technique is just as effective as the traditional one, while also looking at factors like recovery time and any complications.

To participate in this trial, women aged 65 to 74 who have moderate to severe pelvic organ prolapse and are willing to commit to a year of follow-up can apply. However, those with certain prior surgeries, medical conditions that may complicate surgery, or who wish to keep their uterus will not be eligible. Participants will receive one of the two surgical treatments and will be monitored for their recovery and overall satisfaction with the outcome. This study aims to find a potentially better option for women who might struggle with the traditional surgery due to their specific conditions.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patients with symptomatic mid-pelvic organ prolapse (POP-Q stage ≥ II) who may concurrently have anterior and/or posterior pelvic organ prolapse.
• • Patients willing to undergo long-term follow-up for at least one year.
• • Patients willing to sign an informed consent form and participate in this study.
• Exclusion Criteria:
• • Patients who have undergone previous POP or urinary incontinence surgery with the use of implant materials.
• • Patients who require simultaneous anti-urinary incontinence surgery for the current procedure.
• • Contraindications for general anesthesia and surgical intervention, such as severe medical comorbidities that render the patient unable to tolerate surgery.
• • Patients who wish to preserve the uterus.
• • Patients in the active phase of genital, urinary, or systemic infections.
• • Patients who, for other reasons (such as having genital malignancies), choose not to undergo SSLF/modified ISFF surgical intervention at the moment.
• • Patients who are unable or unwilling to attend follow-up visits (excluding those who may be willing to participate in telephone follow-up).