Vaginal Vault ProlapseVVPSTNCT06792331
Vaginal Vault Prolapse Surgical Treatment
An observational study of Vaginal Vault Prolapse and Pelvic Floor Prolapse, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Vaginal Vault Prolapse, Pelvic Floor Prolapse
- What is being tested?
- vNOTES high uterosacral ligament suspension and Laparoscopic lateral suspension
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent vNOTES high uterosacral ligament suspension and laparoscopic lateral suspension
Who may be able to join
- Women with vaginal vault prolapse
Who cannot join
- Women who have previously undergone surgical treatment for pelvic organ prolapse
- Women who needed additional surgery due to anterior or posterior prolapse or stress incontinence
- Pelvic inflammatory disease
- Suspected gynecological malignancy
- Rectovaginal endometriosis
- obliterated rectovaginal space detected on pelvic examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Natural Orifice Transluminal Surgery High Uterosacral Ligament Suspension Versus Laparoscopic Lateral Suspension in the Management of Vaginal Vault Prolapse: Initial Experience in a Single Center With a Median-term Follow-up
Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Laparoscopic lateral suspension (LLS) using mesh is an efficient alternative technique for apical support. In addition, vaginal approaches have been used in cuff prolapsus surgery for many years. Uterosacral ligaments are strong native tissues used in cuff surgery and apical support. In recent years, Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration.
Read the detailed description
Hysterectomy is one of the common surgical procedures in current gynecology practice and is a risk factor for vault prolapse. Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Laparoscopic lateral suspension (LLS) using mesh is an efficient alternative technique for apical support. In addition, vaginal approaches have been used in cuff prolapsus surgery for many years. Uterosacral ligaments are strong native tissues used in cuff surgery and apical support. In recent years, Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration. Lack of incision pain, better cosmetic results, and direct visualization of important structures such as the rectum and ureter that cannot be obtained with the traditional transvaginal approach are important advantages of vNOTES approach.
- Conditions
- Vaginal Vault Prolapse, Pelvic Floor Prolapse
- Being tested
- vNOTES high uterosacral ligament suspension, Laparoscopic lateral suspension
- Keywords
- Vaginal vault prolapse, vNOTES, high uterosacral ligament suspension, lateral suspension, laparoscopy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTES high uterosacral ligament suspensionProcedure or surgery
Following the entry into the peritoneal cavity via apical colpotomy, a transvaginal retractor was inserted through the vaginal vault and the vaginal access platform was established. The ureters and uterosacral ligaments (USL) were identified via laparoscopic view. Bilateral nonabsorbable sutures were placed by the intermediate portions of the USL at the level of the ischial spines making up a total of 4 stitches (Figure 1). Then, the sutures were slightly weighed to verify proper placement. Then, the V-notes platform was removed and the peritoneum was closed. The aforementioned sutures were fixed to the ipsilateral cardinal ligament stump and the pubocervical fascia on the anterior wall. Finally, the previously mentioned nonabsorbable sutures were attached to the vaginal cuff and tied. Routine postoperative cystoscopy was performed.
Laparoscopic lateral suspensionProcedure or surgery
The polypropylene mesh used had a width of 2.5 cm and a length of 25 cm. The vaginal cuff was suspended. Blunt dissection was applied to develop vesicovaginal and rectovaginal spaces. The middle part of the mesh was placed flatly in the vesicovaginal space, and fixed with non-absorbable sutures. An atraumatic laparoscopic instrument was inserted through skin incisions of approximately 2-3 mm approximately 3 cm above and 4 cm lateral to the anterior superior iliac spine, followed by perforation only of the aponeurosis of the external oblique muscle and retroperitoneal advancement of the instrument through the lateral abdominal wall. Under laparoscopic visualization, the instrument moved through the bilateral tension-free retroperitoneal tunnels created. The lateral arms of the mesh were secured bilaterally to the aponeurosis of the external oblique muscle and behind the anterior superior iliac spine. Finally, the peritoneum was closed.
| Study group | Role | What they receive |
|---|---|---|
| Women with vNOTES high uterosacral ligament suspension | Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent vNOTES high uterosacral ligament suspension and laparoscopic lateral suspension. Receives: Procedure: vNOTES high uterosacral ligament suspension | |
| Women with laparoscopic lateral suspension. | Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent laparoscopic lateral suspension. Receives: Procedure: Laparoscopic lateral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical and functional outcomes
Evaluation of Pelvic organ prolapse quantification (POP-Q) scores before and after surgeries.
Clinical assessment of the pelvic floor was performed by a gynecologist experienced in the evaluation of pelvic organ prolapse, while patients were in the supine lithotomy position. In the POP-Q, nine measurement points are assessed during the maximal Valsalva maneuver, except for the transvaginal length (TVL), measured at rest. Only the measurements of POP-Q points Ba, C, Bp were used to compare preoperative and postoperative evaluation. Ba is the most descended edge on the anterior vaginal wall, C represents either the most distal edge of the cervix or the leading edge of the vaginal vault, Bp is the most descended edge on the posterior vagina wall. Measurements in centimeters relative to the hymenal remnants were used in the analysis.
Measured: 14-30 months
Requirement of reoperation
Number and rate of women requiring subsequent surgery for pelvic organ prolapse following the studied surgeries.
Measured: 14-30 months
Subjective recurrence
The presence of bulging symptoms
Measured: 14-30 months
Secondary outcomes (5)
Transition of patient condition after surgery
Patient Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their pelvic organ prolapsus condition now, as compared with how it was before beginning treatment on a scale from 1. Very much better to 7. Very much worse.
Measured: 6 months
Sexual Function
Validated versions of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and Female Sexual Function Index (FSFI) questionnaire11,12 are routinely applied preoperatively and at 6 months postoperatively
Measured: 6 months
Change in quality of life
A seven-point quality of life (QoL) questionnaire ranging from 1 (very much improved) to 7 (very much worse), was used to assess patients' postoperative satisfaction
Measured: 6 months
Change of sexual function
Female Sexual Function Index (FSFI) questionnaire are routinely applied preoperatively and at 6 months postoperatively. The FSFI is a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain. Each item is scored from 0 to 5 except for questions 1, 2, 13-16 (which are scored from 1 to 5).
The 19 items of the FSFI use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning on the respective item. To score the measure, the sum of each domain score is first multiplied by a domain factor ratio (0.6 for desire; 0.3 for arousal; 0.3 for lubrication; 0.4 for orgasm; 0.4 for satisfaction; and 0.4 for pain) to place all domains totals on a more comparable scale, and then subsequently summed to derive a total FSFI score.
Measured: 6 months
Parameters regarding surgery
Duration of surgery in minutes,preoperative-postoperative hemoglobin difference (g/dL), postoperative length of hospital stay (day), number of hospital readmissions after discharge from hospital, intraoperative and postoperative complications via Clavien-Dindo classification.
Measured: 14-30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Jan 2019
- Primary completion30 Jun 2022
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaginal Vault ProlapseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Bilge Tekin, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Investigators
- Arzu B Tekin, Study chair, SBÜ Sancaktepe Şehit Prof Dr İlhan Varank EAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792331
- Sponsor's protocol ID
- VVPST
- Acronym
- VVPST
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu Z, Chen Y, Wang X, Li J, Hua K, Hu C. Transvaginal natural orifice transluminal endoscopic surgery for uterosacral ligament suspension: pilot study of 35 cases of severe pelvic organ prolapse. BMC Surg. 2021 Jun 8;21(1):286. doi: 10.1186/s12893-021-01280-6.
PubMed 34103032Lowenstein L, Baekelandt J, Paz Y, Lauterbach R, Matanes E. Transvaginal Natural Orifice Transluminal Endoscopic Hysterectomy and Apical Suspension of the Vaginal Cuff to the Uterosacral Ligament. J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1015. doi: 10.1016/j.jmig.2019.04.007. Epub 2019 Apr 10.
PubMed 30980991Dubuisson J, Veit-Rubin N, Bouquet de Joliniere J, Dubuisson JB. Laparoscopic Lateral Suspension: Benefits of a Cross-shaped Mesh to Treat Difficult Vaginal Vault Prolapse. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):672. doi: 10.1016/j.jmig.2016.01.028. Epub 2016 Feb 8.
PubMed 26867700
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Natural Orifice Transluminal Surgery High Uterosacral Ligament Suspension Versus Laparoscopic Lateral Suspension in the Management of Vaginal Vault Prolapse: Initial Experience in a Single Center With a Median-term Follow-up
- ClinicalTrials.gov ID
- NCT06792331
- Acronym / sponsor ID
- VVPST / VVPST
- Conditions
- Vaginal Vault Prolapse, Pelvic Floor Prolapse
- Keywords
- Vaginal vault prolapse, vNOTES, high uterosacral ligament suspension, lateral suspension, laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 24 Jan 2025 (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.
Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Laparoscopic lateral suspension (LLS) using mesh is an efficient alternative technique for apical support. In addition, vaginal approaches have been used in cuff prolapsus surgery for many years. Uterosacral ligaments are strong native tissues used in cuff surgery and apical support. In recent years, Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration.
Detailed description
Hysterectomy is one of the common surgical procedures in current gynecology practice and is a risk factor for vault prolapse. Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Laparoscopic lateral suspension (LLS) using mesh is an efficient alternative technique for apical support. In addition, vaginal approaches have been used in cuff prolapsus surgery for many years. Uterosacral ligaments are strong native tissues used in cuff surgery and apical support. In recent years, Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration. Lack of incision pain, better cosmetic results, and direct visualization of important structures such as the rectum and ureter that cannot be obtained with the traditional transvaginal approach are important advantages of vNOTES approach.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with vNOTES high uterosacral ligament suspension | – | Procedure: vNOTES high uterosacral ligament suspensionSymptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent vNOTES high uterosacral ligament suspension and laparoscopic lateral suspension. |
| Women with laparoscopic lateral suspension. | – | Procedure: Laparoscopic lateral suspensionSymptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent laparoscopic lateral suspension. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent vNOTES high uterosacral ligament suspension and laparoscopic lateral suspension
Key inclusion criteria (1 listed)
- Women with vaginal vault prolapse
Key exclusion criteria (6 listed)
- Women who have previously undergone surgical treatment for pelvic organ prolapse
- Women who needed additional surgery due to anterior or posterior prolapse or stress incontinence
- Pelvic inflammatory disease
- Suspected gynecological malignancy
- Rectovaginal endometriosis
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 |
|---|---|---|
| vNOTES high uterosacral ligament suspensionFollowing the entry into the peritoneal cavity via apical colpotomy, a transvaginal retractor was inserted through the vaginal vault and the vaginal access platform was established. The ureters and uterosacral ligaments (USL) were identified via laparoscopic view. Bilateral nonabsorbable sutures were placed by the intermediate portions of the USL at the level of the ischial spines making up a total of 4 stitches (Figure 1). Then, the sutures were slightly weighed to verify proper placement. Then, the V-notes platform was removed and the peritoneum was closed. The aforementioned sutures were fixed to the ipsilateral cardinal ligament stump and the pubocervical fascia on the anterior wall. Finally, the previously mentioned nonabsorbable sutures were attached to the vaginal cuff and tied. Routine postoperative cystoscopy was performed. | Procedure or surgery | Women with vNOTES high uterosacral ligament suspension |
| Laparoscopic lateral suspensionThe polypropylene mesh used had a width of 2.5 cm and a length of 25 cm. The vaginal cuff was suspended. Blunt dissection was applied to develop vesicovaginal and rectovaginal spaces. The middle part of the mesh was placed flatly in the vesicovaginal space, and fixed with non-absorbable sutures. An atraumatic laparoscopic instrument was inserted through skin incisions of approximately 2-3 mm approximately 3 cm above and 4 cm lateral to the anterior superior iliac spine, followed by perforation only of the aponeurosis of the external oblique muscle and retroperitoneal advancement of the instrument through the lateral abdominal wall. Under laparoscopic visualization, the instrument moved through the bilateral tension-free retroperitoneal tunnels created. The lateral arms of the mesh were secured bilaterally to the aponeurosis of the external oblique muscle and behind the anterior superior iliac spine. Finally, the peritoneum was closed. | Procedure or surgery | Women with laparoscopic lateral suspension. |
Primary outcome
Anatomical and functional outcomes
Time frame: 14-30 months
Evaluation of Pelvic organ prolapse quantification (POP-Q) scores before and after surgeries. Clinical assessment of the pelvic floor was performed by a gynecologist experienced in the evaluation of pelvic organ prolapse, while patients were in the supine lithotomy position. In the POP-Q, nine measurement points are assessed during the maximal Valsalva maneuver, except for the transvaginal length (TVL), measured at rest. Only the measurements of POP-Q points Ba, C, Bp were used to compare preoperative and postoperative evaluation. Ba is the most descended edge on the anterior vaginal wall, C represents either the most distal edge of the cervix or the leading edge of the vaginal vault, Bp is the most descended edge on the posterior vagina wall. Measurements in centimeters relative to the hymenal remnants were used in the analysis.
Requirement of reoperation
Time frame: 14-30 months
Number and rate of women requiring subsequent surgery for pelvic organ prolapse following the studied surgeries.
Subjective recurrence
Time frame: 14-30 months
The presence of bulging symptoms
5 secondary outcomes
Transition of patient condition after surgery
Time frame: 6 months
Sexual Function
Time frame: 6 months
Change in quality of life
Time frame: 6 months
Change of sexual function
Time frame: 6 months
Parameters regarding surgery
Time frame: 14-30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Background: PubMed 34103032Lu Z, Chen Y, Wang X, Li J, Hua K, Hu C. Transvaginal natural orifice transluminal endoscopic surgery for uterosacral ligament suspension: pilot study of 35 cases of severe pelvic organ prolapse. BMC Surg. 2021 Jun 8;21(1):286. doi: 10.1186/s12893-021-01280-6.
- Background: PubMed 30980991Lowenstein L, Baekelandt J, Paz Y, Lauterbach R, Matanes E. Transvaginal Natural Orifice Transluminal Endoscopic Hysterectomy and Apical Suspension of the Vaginal Cuff to the Uterosacral Ligament. J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1015. doi: 10.1016/j.jmig.2019.04.007. Epub 2019 Apr 10.
- Background: PubMed 26867700Dubuisson J, Veit-Rubin N, Bouquet de Joliniere J, Dubuisson JB. Laparoscopic Lateral Suspension: Benefits of a Cross-shaped Mesh to Treat Difficult Vaginal Vault Prolapse. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):672. doi: 10.1016/j.jmig.2016.01.028. Epub 2016 Feb 8.
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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. This study is not recruiting at the moment.
Arzu B Tekin study chair
SBÜ Sancaktepe Şehit Prof Dr İlhan Varank EAH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Vault Prolapse and Pelvic Floor Prolapse, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jan 2025. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical and functional outcomes (time frame: 14-30 months). The study lists 3 primary outcomes in all. 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 NCT06792331, which also lists 3 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 24 Jan 2025.