Prolapse PelvicVENUSNCT07413861
Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension
A study testing Uterosacral suspension and Hysterectomy by vNOTES approach in people with Prolapse Pelvic and Hysterectomy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
As the adoption of Vaginal natural orifice transluminal endoscopic surgery (vNOTES) expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolapse Pelvic, Hysterectomy
- What is being tested?
- Uterosacral suspension and Hysterectomy by vNOTES approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>18
- All women undergoing vNOTES hysterectomy ± Bilateral salpingectomy/salpingo-oopherectomy for benign gynecological indication
Who cannot join
- Exclusion for vNOTES surgery: pelvic inflammatory disease, previous rectal surgery, suspected malignancy, radiation
- Indication for surgery: elvic prolapse
- Other surgical interventions planned for the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas
Houston, Texas, 77030
Aya Mohr-Sasson, M.D, 346-270-4682, aya.mohrsasson@uth.tmc.edu
Sunbola Ashimi, sunbola.s.ashimi@uth.tmc.edu
About this study
As the adoption of Vaginal natural orifice transluminal endoscopic surgery (vNOTES) expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health.
One technical distinction between vNOTES hysterectomy and conventional laparoscopic or robotic hysterectomy is the routine early transection of the uterosacral ligaments as the approach is caudal-cephalic. These ligaments are not merely anatomic landmarks-they are the primary apical support structures of the vagina, anchoring the vaginal cuff to the sacrum and providing resistance against downward displacement. Disruption of this support can predispose patients to apical vaginal prolapse, a condition that significantly affects quality of life and may require complex reconstructive surgery.
Read more
Uterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Incorporating uterosacral suspension into vNOTES hysterectomy is a logical evolution toward ensuring that minimally invasive innovation does not come at the expense of long-term pelvic health. By adapting and standardizing this reconstructive step for vNOTES, surgeons can maintain apical support, reduce future prolapse risk, and uphold the same quality benchmarks established in laparoscopic and vaginal surgery.
OBJECTIVE AND HYPOTHESIS:
This study aims to present a practical, reproducible technique for performing USLS in the vNOTES setting and to evaluate its potential immediate benefits, possible complication rates, and additional operative time compared with vNOTES hysterectomy without USLS. In doing so, we seek to demonstrate that preventive pelvic support can be seamlessly integrated without compromising the efficiency or advantages of the transvaginal endoscopic approach.
Read the detailed description
- BACKGROUND AND RATIONALE: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a novel minimally invasive surgical technique that combines the advantages of laparoscopy with a natural orifice approach, eliminating the need for abdominal incisions. By accessing the peritoneal cavity via the vagina, vNOTES offers benefits such as reduced postoperative pain, faster recovery, fewer wound-related complications, and improved cosmetic outcomes. Over the past decade, it has been successfully applied to a broad spectrum of gynecologic procedures, including adnexal surgery and hysterectomy, with growing evidence supporting its safety and feasibility in both benign and complex cases. As the adoption of vNOTES expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health. One technical distinction between vNOTES hysterectomy and conventional laparoscopic or robotic hysterectomy is the routine early transection of the uterosacral ligaments as the approach is caudal-cephalic. These ligaments are not merely anatomic landmarks-they are the primary apical support structures of the vagina, anchoring the vaginal cuff to the sacrum and providing resistance against downward displacement. Disruption of this support can predispose patients to apical vaginal prolapse, a condition that significantly affects quality of life and may require complex reconstructive surgery. In traditional vaginal or abdominal hysterectomy, preserving or reconstructing apical support is considered standard of care to minimize this risk. Uterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Multiple randomized and observational studies have demonstrated that performing USLS prophylactically can significantly reduce the incidence of postoperative vault prolapse, aligning with pelvic reconstructive principles and the American College of Obstetricians and Gynecologists (ACOG) recommendations. Beyond prevention, USLS also improves pelvic floor function, reduces the need for future surgery, and preserves vaginal axis and length. Its application in minimally invasive hysterectomy is now routine in many centers, yet in vNOTES procedures, this important step has not been widely integrated. Incorporating uterosacral suspension into vNOTES hysterectomy is a logical evolution toward ensuring that minimally invasive innovation does not come at the expense of long-term pelvic health. By adapting and standardizing this reconstructive step for vNOTES, surgeons can maintain apical support, reduce future prolapse risk, and uphold the same quality benchmarks established in laparoscopic and vaginal surgery.
- OBJECTIVE AND HYPOTHESIS:
This study aims to present a practical, reproducible technique for performing USLS in the vNOTES setting and to evaluate its potential immediate benefits, possible complication rates, and additional operative time compared with vNOTES hysterectomy without USLS. In doing so, we seek to demonstrate that preventive pelvic support can be seamlessly integrated without compromising the efficiency or advantages of the transvaginal endoscopic approach.
- Conditions
- Prolapse Pelvic, Hysterectomy
- Being tested
- Uterosacral suspension, Hysterectomy by vNOTES approach
- Keywords
- hysterectomy, prevention, pelvic prolapse, uterosacral suspension, vaginal surgery, vaginal natural orifice transluminal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterosacral suspensionProcedure or surgery
Placement of two suspension sutures on the uterosacral ligament on each side
Hysterectomy by vNOTES approachProcedure or surgery
Hysterectomy with or without adnexectomy performed by vaginal natural orifice transluminal endoscopic surgery (vNOTES)
| Study group | Role | What they receive |
|---|---|---|
| Hysterectomy by vNOTES approach followed by uterosacral suspension | Active comparator | Two suspension sutures will be placed on the uterosacral ligament on each side after the completion of the hysterectomy Receives: Procedure: Uterosacral suspension; Procedure: Hysterectomy by vNOTES approach |
| Hysterectomy by vNOTES approach | Placebo comparator | No additional intervention will be done following hysterectomy Receives: Procedure: Hysterectomy by vNOTES approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal length difference (Delta)
The calculated difference in total vaginal length before minus after surgery, evaluated by hysterometer
Measured: From intubating to extubating the patient during surgery
Secondary outcomes (3)
Surgery length
Surgical length in minutes
Measured: From intubating to extubating the patient during surgery
Surgical complications
Evaluated as a compound parameter including: Excessive bleeding (>500 cc), damage to adjacent organ (bladder, bowel, great vessel), change in surgical approach
Measured: From intubating to extubating the patient during surgery
Visual analog scale (VAS) score
Pain will be assessed using a visual analog scale (VAS) ranging from 1 to 10, where 1 represents no pain and 10 represents the worst imaginable pain.
Measured: From immediately after surgery in the post-anesthesia care unit (PACU) until postoperative day 1 (POD1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Sep 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prolapse PelvicStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohr Sasson, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413861
- Sponsor's protocol ID
- HSC-MS-25-0000
- Acronym
- VENUS
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martins SB, Castro RA, Takano CC, Marquini GV, Oliveira LM, Martins Junior PCF, Dias MM, Girao MJBC, Sartori MGF. Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial. Rev Bras Ginecol Obstet. 2023 Oct;45(10):e584-e593. doi: 10.1055/s-0043-1772592. Epub 2023 Nov 9.
PubMed 37944925Manodoro S, Frigerio M, Milani R, Spelzini F. Tips and tricks for uterosacral ligament suspension: how to avoid ureteral injury. Int Urogynecol J. 2018 Jan;29(1):161-163. doi: 10.1007/s00192-017-3497-y. Epub 2017 Oct 16.
PubMed 29038833Aronson MP, Aronson PK, Howard AE, Morse AN, Baker SP, Young SB. Low risk of ureteral obstruction with "deep" (dorsal/posterior) uterosacral ligament suture placement for transvaginal apical suspension. Am J Obstet Gynecol. 2005 May;192(5):1530-6. doi: 10.1016/j.ajog.2004.10.608.
PubMed 15902153Altman D, Falconer C, Cnattingius S, Granath F. Pelvic organ prolapse surgery following hysterectomy on benign indications. Am J Obstet Gynecol. 2008 May;198(5):572.e1-6. doi: 10.1016/j.ajog.2008.01.012. Epub 2008 Mar 20.
PubMed 18355787Lerner VT, May G, Iglesia CB. Vaginal Natural Orifice Transluminal Endoscopic Surgery Revolution: The Next Frontier in Gynecologic Minimally Invasive Surgery. JSLS. 2023 Jan-Mar;27(1):e2022.00082. doi: 10.4293/JSLS.2022.00082.
PubMed 36818766Li CB, Hua KQ. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgeries: A systematic review. Asian J Surg. 2020 Jan;43(1):44-51. doi: 10.1016/j.asjsur.2019.07.014. Epub 2019 Aug 20.
PubMed 31444108Housmans S, Noori N, Kapurubandara S, Bosteels JJA, Cattani L, Alkatout I, Deprest J, Baekelandt J. Systematic Review and Meta-Analysis on Hysterectomy by Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Laparoscopic Hysterectomy for Benign Indications. J Clin Med. 2020 Dec 7;9(12):3959. doi: 10.3390/jcm9123959.
PubMed 33297354
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension
- ClinicalTrials.gov ID
- NCT07413861
- Acronym / sponsor ID
- VENUS / HSC-MS-25-0000
- Conditions
- Prolapse Pelvic, Hysterectomy
- Keywords
- hysterectomy, prevention, pelvic prolapse, uterosacral suspension, vaginal surgery, vaginal natural orifice transluminal surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As the adoption of Vaginal natural orifice transluminal endoscopic surgery (vNOTES) expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health.
One technical distinction between vNOTES hysterectomy and conventional laparoscopic or robotic hysterectomy is the routine early transection of the uterosacral ligaments as the approach is caudal-cephalic. These ligaments are not merely anatomic landmarks-they are the primary apical support structures of the vagina, anchoring the vaginal cuff to the sacrum and providing resistance against downward displacement. Disruption of this support can predispose patients to apical vaginal prolapse, a condition that significantly affects quality of life and may require complex reconstructive surgery.
Uterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Incorporating uterosacral suspension into vNOTES hysterectomy is a logical evolution toward ensuring that minimally invasive innovation does not come at the expense of long-term pelvic health. By adapting and standardizing this reconstructive step for vNOTES, surgeons can maintain apical support, reduce future prolapse risk, and uphold the same quality benchmarks established in laparoscopic and vaginal surgery.
OBJECTIVE AND HYPOTHESIS:
This study aims to present a practical, reproducible technique for performing USLS in the vNOTES setting and to evaluate its potential immediate benefits, possible complication rates, and additional operative time compared with vNOTES hysterectomy without USLS. In doing so, we seek to demonstrate that preventive pelvic support can be seamlessly integrated without compromising the efficiency or advantages of the transvaginal endoscopic approach.
Detailed description
- BACKGROUND AND RATIONALE: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a novel minimally invasive surgical technique that combines the advantages of laparoscopy with a natural orifice approach, eliminating the need for abdominal incisions. By accessing the peritoneal cavity via the vagina, vNOTES offers benefits such as reduced postoperative pain, faster recovery, fewer wound-related complications, and improved cosmetic outcomes. Over the past decade, it has been successfully applied to a broad spectrum of gynecologic procedures, including adnexal surgery and hysterectomy, with growing evidence supporting its safety and feasibility in both benign and complex cases. As the adoption of vNOTES expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health. One technical distinction between vNOTES hysterectomy and conventional laparoscopic or robotic hysterectomy is the routine early transection of the uterosacral ligaments as the approach is caudal-cephalic. These ligaments are not merely anatomic landmarks-they are the primary apical support structures of the vagina, anchoring the vaginal cuff to the sacrum and providing resistance against downward displacement. Disruption of this support can predispose patients to apical vaginal prolapse, a condition that significantly affects quality of life and may require complex reconstructive surgery. In traditional vaginal or abdominal hysterectomy, preserving or reconstructing apical support is considered standard of care to minimize this risk. Uterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Multiple randomized and observational studies have demonstrated that performing USLS prophylactically can significantly reduce the incidence of postoperative vault prolapse, aligning with pelvic reconstructive principles and the American College of Obstetricians and Gynecologists (ACOG) recommendations. Beyond prevention, USLS also improves pelvic floor function, reduces the need for future surgery, and preserves vaginal axis and length. Its application in minimally invasive hysterectomy is now routine in many centers, yet in vNOTES procedures, this important step has not been widely integrated. Incorporating uterosacral suspension into vNOTES hysterectomy is a logical evolution toward ensuring that minimally invasive innovation does not come at the expense of long-term pelvic health. By adapting and standardizing this reconstructive step for vNOTES, surgeons can maintain apical support, reduce future prolapse risk, and uphold the same quality benchmarks established in laparoscopic and vaginal surgery.
- OBJECTIVE AND HYPOTHESIS:
This study aims to present a practical, reproducible technique for performing USLS in the vNOTES setting and to evaluate its potential immediate benefits, possible complication rates, and additional operative time compared with vNOTES hysterectomy without USLS. In doing so, we seek to demonstrate that preventive pelvic support can be seamlessly integrated without compromising the efficiency or advantages of the transvaginal endoscopic approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysterectomy by vNOTES approach followed by uterosacral suspension | Active comparator | Procedure: Uterosacral suspension, Procedure: Hysterectomy by vNOTES approachTwo suspension sutures will be placed on the uterosacral ligament on each side after the completion of the hysterectomy |
| Hysterectomy by vNOTES approach | Placebo comparator | Procedure: Hysterectomy by vNOTES approachNo additional intervention will be done following hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18
- All women undergoing vNOTES hysterectomy ± Bilateral salpingectomy/salpingo-oopherectomy for benign gynecological indication
Key exclusion criteria (3 listed)
- Exclusion for vNOTES surgery: pelvic inflammatory disease, previous rectal surgery, suspected malignancy, radiation
- Indication for surgery: elvic prolapse
- Other surgical interventions planned for the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterosacral suspensionPlacement of two suspension sutures on the uterosacral ligament on each side | Procedure or surgery | Hysterectomy by vNOTES approach followed by uterosacral suspension |
| Hysterectomy by vNOTES approachHysterectomy with or without adnexectomy performed by vaginal natural orifice transluminal endoscopic surgery (vNOTES) | Procedure or surgery | Hysterectomy by vNOTES approach, Hysterectomy by vNOTES approach followed by uterosacral suspension |
Primary outcome
Vaginal length difference (Delta)
Time frame: From intubating to extubating the patient during surgery
The calculated difference in total vaginal length before minus after surgery, evaluated by hysterometer
3 secondary outcomes
Surgery length
Time frame: From intubating to extubating the patient during surgery
Surgical complications
Time frame: From intubating to extubating the patient during surgery
Visual analog scale (VAS) score
Time frame: From immediately after surgery in the post-anesthesia care unit (PACU) until postoperative day 1 (POD1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Results publication: PubMed 37944925Martins SB, Castro RA, Takano CC, Marquini GV, Oliveira LM, Martins Junior PCF, Dias MM, Girao MJBC, Sartori MGF. Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial. Rev Bras Ginecol Obstet. 2023 Oct;45(10):e584-e593. doi: 10.1055/s-0043-1772592. Epub 2023 Nov 9.
- Results publication: PubMed 29038833Manodoro S, Frigerio M, Milani R, Spelzini F. Tips and tricks for uterosacral ligament suspension: how to avoid ureteral injury. Int Urogynecol J. 2018 Jan;29(1):161-163. doi: 10.1007/s00192-017-3497-y. Epub 2017 Oct 16.
- Results publication: PubMed 15902153Aronson MP, Aronson PK, Howard AE, Morse AN, Baker SP, Young SB. Low risk of ureteral obstruction with "deep" (dorsal/posterior) uterosacral ligament suture placement for transvaginal apical suspension. Am J Obstet Gynecol. 2005 May;192(5):1530-6. doi: 10.1016/j.ajog.2004.10.608.
- Results publication: PubMed 18355787Altman D, Falconer C, Cnattingius S, Granath F. Pelvic organ prolapse surgery following hysterectomy on benign indications. Am J Obstet Gynecol. 2008 May;198(5):572.e1-6. doi: 10.1016/j.ajog.2008.01.012. Epub 2008 Mar 20.
- Results publication: PubMed 36818766Lerner VT, May G, Iglesia CB. Vaginal Natural Orifice Transluminal Endoscopic Surgery Revolution: The Next Frontier in Gynecologic Minimally Invasive Surgery. JSLS. 2023 Jan-Mar;27(1):e2022.00082. doi: 10.4293/JSLS.2022.00082.
- Results publication: PubMed 31444108Li CB, Hua KQ. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgeries: A systematic review. Asian J Surg. 2020 Jan;43(1):44-51. doi: 10.1016/j.asjsur.2019.07.014. Epub 2019 Aug 20.
- Results publication: PubMed 33297354Housmans S, Noori N, Kapurubandara S, Bosteels JJA, Cattani L, Alkatout I, Deprest J, Baekelandt J. Systematic Review and Meta-Analysis on Hysterectomy by Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Laparoscopic Hysterectomy for Benign Indications. J Clin Med. 2020 Dec 7;9(12):3959. doi: 10.3390/jcm9123959.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterosacral suspension and Hysterectomy by vNOTES approach in people with Prolapse Pelvic and Hysterectomy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Mohr Sasson, MD (346-270-4682, aya.mohrsasson@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal length difference (Delta) (time frame: From intubating to extubating the patient during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07413861, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.