Comparing two surgical methods for pelvic organ prolapse treatment
Official title: A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension
Run by National Cheng-Kung University Hospital · NCT05586984 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 21 Years and up |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan) |
| Status | Recruiting |
| Started | July 26, 2022 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | October 21, 2022 |
| Trial ID | NCT05586984 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women over 21 years old with at least stage 2 uterine prolapse who are seeking uterus-preserving surgical options.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While laparoscopic approaches have shown promise in other studies, this specific comparison of techniques is novel and has not been extensively tested.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Deep muscle relaxation and a low-residue diet to improve the surgical view during vNOTES hysterectomy
This trial tests whether a preoperative low-residue diet and deeper muscle relaxation help doctors see better during a vaginally performed hysterectomy for benign conditions.
-
Improving Uroflowmetry: Do Pre-Procedure Reminders Help Women Undergoing Urodynamics
This study tests whether sending reminder calls before a urodynamics test helps women with pelvic floor disorders feel more prepared and less anxious, and whether it makes the procedure go more smoothly.
-
Combined pelvic floor retraining and hypopressive exercises for uterine prolapse outcomes
This study tests whether adding Hypopressive Exercises to Pelvic Floor Functional Movement Retraining helps improve pain, urinary symptoms, and quality of life for women with stage I-II uterine prolapse.
-
Comparing the Manchester procedure versus vaginal hysterectomy for uterine prolapse
This study tests whether the Manchester procedure or vaginal hysterectomy works better for women with symptomatic uterine prolapse over a two-year follow-up.
-
Vaginal Vault Support at Hysterectomy
This trial tests a new double-ligament vault suspension during hysterectomy to help prevent vaginal apex prolapse in women undergoing the procedure.
-
Centered Surgery: Preoperative Counseling to Improve Patient Satisfaction
This study will test whether virtual group counseling sessions (shared medical appointments) help adults having pelvic organ prolapse surgery feel more satisfied and better prepared compared with standard individual phone calls.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.