vNOTES Hysterectomy for Pelvic Prolapse
(VENUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a method to improve a type of minimally invasive surgery called vNOTES, used for treating pelvic prolapse during a hysterectomy. It examines the addition of a procedure called uterosacral suspension, which supports the pelvic area and may reduce the risk of future prolapse. The study compares this approach with standard vNOTES hysterectomy to determine if it provides additional benefits without extra complications. Women scheduled for a vNOTES hysterectomy for non-cancerous conditions might be eligible for this trial. As an unphased trial, it offers participants the chance to contribute to innovative surgical advancements that could enhance future treatment options.
What prior data suggests that the vNOTES hysterectomy with uterosacral suspension is safe?
Research has shown that the vNOTES method, which stands for vaginal natural orifice transluminal endoscopic surgery, is generally safe and effective. This includes a technique called uterosacral ligament suspension (USLS). Studies have found that complications are rare. For example, in one study, only 1.8% of patients experienced issues during or after surgery. Another study reported that problems during surgery, such as bladder injury, occurred in just 2.1% of cases.
USLS reliably supports the pelvic area during a hysterectomy, helping to prevent issues like pelvic organ prolapse, where pelvic organs move out of place. The vNOTES method, combined with USLS, has been shown to lower the risk of complications during surgery and may even reduce the time patients spend in surgery or under anesthesia.
Overall, the vNOTES method with uterosacral suspension appears to be a well-tolerated technique that provides effective support with minimal risk.12345Why are researchers excited about this trial?
Researchers are excited about using the vNOTES hysterectomy approach followed by uterosacral suspension for treating pelvic prolapse because it offers a minimally invasive way to address this condition. Unlike traditional open or laparoscopic surgeries, the vNOTES (vaginal natural orifice transluminal endoscopic surgery) method allows for surgery through natural openings, potentially reducing recovery time and surgical trauma. Additionally, the uterosacral suspension technique provides extra support to the pelvic organs by securing them to strong pelvic ligaments, which might lead to better long-term outcomes in preventing prolapse recurrence. This combination could offer a less invasive, more effective alternative to current surgical options like abdominal or vaginal hysterectomy with pelvic floor repair.
What evidence suggests that this trial's treatments could be effective for pelvic prolapse?
Research has shown that uterosacral ligament suspension (USLS) effectively treats pelvic organ prolapse. This trial will compare two approaches: one group will undergo a hysterectomy using the vNOTES approach alone, while another group will have a hysterectomy followed by uterosacral suspension using the vNOTES approach. Studies indicate that USLS is safe and provides long-lasting results, with high success rates in maintaining pelvic health. For instance, one study found an 89.3% success rate for different types of prolapse. Another study highlighted that the procedure leads to high patient satisfaction and positive outcomes. Overall, USLS is a proven method to improve pelvic support and prevent future problems.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo vNOTES hysterectomy with or without uterosacral suspension
Immediate Postoperative
Participants are monitored for immediate postoperative recovery and complications
Follow-up
Participants are monitored for safety and effectiveness after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Uterosacral Suspension
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Two suspension sutures will be placed on the uterosacral ligament on each side after the completion of the hysterectomy
No additional intervention will be done following hysterectomy
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Citations
Outcomes of uterosacral ligaments suspension for ...
Results: A total of 1099 patients underwent high uterosacral ligaments suspension. The total complication rate was 3.4 % and recurrence in any of the vaginal ...
Outcomes of uterosacral ligaments suspension for ...
Uterosacral ligament suspension is a safe and effective procedure for primary surgical treatment of pelvic organ prolapse.
Outcomes after vaginal versus robot assisted uterosacral ...
Vaginal and robotic uterosacral ligament suspension are effective at addressing pelvic organ prolapse. The robotic group had more negative Ba, Bp and C points.
Efficacy of Sacrospinous Fixation or Uterosacral Ligament ...
The rates of adverse outcomes were of 42% (N = 11) and 36% (N = 11) for the USLS and SSLF groups respectively ( p = 0.654), and those outcomes were excessive ...
Uterosacral Ligament Suspension (ULS) vs Sacrospinous ...
Findings The estimated probability of surgical failure was 61.5% with uterosacral ligament suspension vs 70.3% with sacrospinous ligament ...
Vaginal hysterectomy and transvaginal natural orifice ... - PMC
The objective of this study was to describe the single-surgeon experience on transvaginal natural orifice transluminal endoscopic surgery for uterosacral ...
Two-Year Follow-Up on Surgical Outcomes of vNOTES ...
The procedure demonstrated a low complication rate, with intraoperative and postoperative complications each observed in 1.8% of patients (n = 1). Keywords.
Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) ...
Uterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Multiple randomized and ...
Transvaginal natural orifice transluminal endoscopic ...
Conclusion: vNOTES hysterectomy with USLS is associated with reduced incidence of intraoperative complications, shorter surgical and anesthesia time, and ...
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journals.lww.com
journals.lww.com/greenjournal/fulltext/2026/04001/insights_and_pearls_for_uterosacral_suspension_in.58.aspxInsights and Pearls for Uterosacral Suspension in vNOTES...
As adoption of vNOTES increases, attention to long-term outcomes, including pelvic organ support, becomes essential. Integrating uterosacral suspension as a ...
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