Comparing two surgical methods for pelvic organ prolapse treatment
A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension
This study is testing two different surgical methods to see which one works better and is safer for women with pelvic organ prolapse who need surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan) |
| Trial ID | NCT05586984 on ClinicalTrials.gov |
What this trial studies
This study compares the therapeutic efficacy and safety of laparoscopic uterine lateral suspension with transvaginal sacrospinous ligament fixation for treating pelvic organ prolapse. It focuses on patients who are dissatisfied with conservative treatments or have severe symptoms requiring surgical intervention. The trial aims to evaluate long-term outcomes, including safety and adverse events associated with both surgical approaches. By analyzing these methods, the study seeks to provide insights into the best practices for uterus-preserving surgeries.
Who should consider this trial
Good fit: Ideal candidates are women over 21 years old with at least stage 2 uterine prolapse who are seeking uterus-preserving surgical options.
Not a fit: Patients who have had previous hysterectomies or surgeries for pelvic organ prolapse, or those with certain comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options for women suffering from pelvic organ prolapse, enhancing recovery times and reducing complications.
How similar studies have performed: While laparoscopic approaches have shown promise in other studies, this specific comparison of techniques is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * older than 21 years old. * uterine prolapse stage 2 at least, defined by C point distal to -1cm by POP-Q system. * patients willing to receive a uterine-preserving surgery for pelvic organ prolapse, and is suitable for anesthesia after evaluation. * patients who had or had not received conservative treatments for pelvic organ prolapse. * patients able and willing to finish the questionnaire evaluation. Exclusion Criteria: * patient who had received a previous hysterectomy, or is planning on concomitant hysterectomy in the surgery for pelvic organ prolapse. * patient who had received a previous surgery for pelvic organ prolapse. * patient with history of adverse events following a synthetic mesh. * patients with chronic or acute pelvic pain. * patients who had received abdominal or pelvic irradiation. * patients who cannot receive either surgery due to comorbidity. * patients pregnant or with future plan of pregnancy. * patients with vaginal length less than 5cm.
Where this trial is running
Tainan
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Yu Fang Huang, MD
- Email: yufangh@ncku.edu.tw
- Phone: 886-6-2353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.