Vaginal Vault Prolapse Surgical Treatment (VVPST)

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Vault Prolapse; Pelvic Floor Prolapse
• Intervention / Treatment: Procedure: vNOTES high uterosacral ligament suspension; Procedure: Laparoscopic lateral suspension

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 Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Turkey
  • Sancaktepe
    • Istanbul, Sancaktepe, Turkey, 34785
      • Arzu Bilge Tekin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• Women with vaginal vault prolapse

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: vNOTES high uterosacral ligament suspension; 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.
Women with laparoscopic lateral suspension.; Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent laparoscopic lateral suspension.	Procedure: Laparoscopic lateral suspension; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14-30 months
Requirement of reoperation	Number and rate of women requiring subsequent surgery for pelvic organ prolapse following the studied surgeries.	14-30 months
Subjective recurrence	The presence of bulging symptoms	14-30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	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.	14-30 months

Collaborators and Investigators

• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Investigators: Study Chair: Arzu B Tekin, SBÜ Sancaktepe Şehit Prof Dr İlhan Varank EAH

Publications and helpful links

General 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.
• Lowenstein 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.
• Dubuisson 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: January 11, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: laparoscopy; vNOTES; lateral suspension; Vaginal vault prolapse; high uterosacral ligament suspension
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: VVPST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No