The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy

The Influence of Augmentation of the Anterior Vaginal Wall With a Vascularized Flap on the Effectiveness of Mesh-augmented Sacrospinous Hysteropexy and Anterior Subfascial Colporrhaphy During Reconstruction of the Pelvic Floor for POP

This is a prospective randomized controlled trial designed to compare the effectiveness and safety of two methods of pelvic floor reconstruction in patients with pelvic organ prolapse (POP): sacrospinous hysteropexy (SSHP) with synthetic mesh, vascularized anterior vaginal wall flap, anterior colporrhaphy, and sacrospinous hysteropexy with synthetic mesh. , anterior colporrhaphy, as well as the impact of surgery on quality of life.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy; Procedure: Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy

Detailed Description

BACKGROUND POP is an epidemiologically widespread condition, occurring in 40-60% of women who have given birth. With all the variety of anatomical defects of the pelvic floor, the most common variant is prolapse of the anterior vaginal wall (cystocele).

Of the currently known surgical methods for the treatment of cystocele, anterior colporrhaphy occupies one of the most key places. However, the high recurrence rate of 7-23%, and according to some authors more than 90%, has led to the development of new techniques. In 1997, M. Cosson proposed the "Plastron" method, the essence of which is to close the defect of the pubocervical fascia by fixing a de-epithelialized flap of the anterior vaginal wall to the tendinous arch of the pelvic fascia and then performing anterior colporrhaphy over it. The method was effective in 93.5% of cases in patients with cystocele. At the same time, apical prolapse is present in many women with cystocele. Apical support is important in maintaining normal pelvic floor anatomy. Patients who undergo anterior vaginal wall repair with concomitant repair of the apical defect have a lower risk of reoperation for POP.

There are various methods for restoring apical defects while preserving the uterus. SSHP is the most studied method and was originally performed using sutures. The use of transvaginal mesh for SSHP remains controversial due to the high risk of mesh-associated complications, although many authors report the safety and high effectiveness of the SSHP method using transvaginal mesh. Despite this, the issue of cystocele recurrence after SSHP (with or without mesh) in combination with anterior colporrhaphy remains unresolved.

PREOPERATIVE ASSESSMENT All patients who meet eligibility criteria will undergo a preoperative assessment: medical history, physical and vaginal examination, assessing pelvic organ prolapse according to Pelvic Organ Prolapse Quantification System (POP-Q). All patients will complete questionnaires validated in Russia: Pelvic Floor Disability Index (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, short form (PISQ-SF), Patient Global Impression of Improvement (PGI-I).

MATERIALS AND METHODS The investigators hypothesis is that is that the use of a deepithelialized vascularized flap of the anterior vaginal wall when performing mesh-augmented sacrospinous hysteropexy and anterior subfascial colporrhaphy reduces the risks of developing relapses of POP in the anterior compartment.

The sample size was calculated taking into account the reported rate of cystocele recurrence using each technique in the literature (6.5% for sacrospinous hysteropexy using vaginal flap vs. 38.7% for mesh-augmented sacrospinous hysteropexy using subfascial colporrhaphy). With a power of 80%, a level of 0,05 and the non-inferiority margin at 15%, the sample size is 50 patients. The investigators assume a drop-out rate of 20%, thus a total of 60 participants will be included in the study.

All enrolled patients will be randomly assigned to SSHP using mesh, vaginal flap and anterior colporrhaphy or SSHP using mesh and anterior colporrhaphy treatment groups in equal ratio the day before the surgery, using computer randomization.

All data will be collected by medical staff not involved in treatment. Collected pre- and postoperative data will be anonymized using unique codes, that patients will receive immediately after randomization.

All surgical interventions will be performed by 3 qualified surgeons. Postoperative follow-up will be performed 6 and 12 months after surgery by 2 researchers, who will be blinded about the type of intervention.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rustam Shakhaliev, MD; Phone Number: +79312368664; Email: rustam.shahaliev@gmail.com
• Study Contact Backup: Name: Denis Suchkov, MD; Phone Number: +79995218976; Email: denis.urolog@yandex.ru

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 190103
    • Recruiting
    • Saint-Petersburg State University Hospital
    • Contact: Denis Suchkov, MD; Phone Number: +79995218976; Email: denis.urolog@yandex.ru

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• The subject is a woman with anterior and apical compartment pelvic organ prolapse
• The age of a subject is 45-80 years
• Leading point of prolapse is at the level of the hymen or distal to the hymen (Ba, C>=1 according to POP-Q classification)
• The subject gave written consent to participate in the study
• The subject is able to evaluate the risks of the treatment and make an independent decision on participation in the study
• The subject is able to fill up validated questionnaires and come to the control visit after the surgery

Exclusion Criteria:

• The subject has an active urinary tract infection or skin infection in the region of surgery or acute infectious disease
• The subject had prior hysterectomy
• The subject has previously diagnosed or currently active cancer
• The subject has chronic pelvic pain
• The subject has cervical elongation
• The subject has gynecological diseases (recurrent uterine bleeding, endometrial hyperplasia, the presence of atypical cells in cervical smears, adenomyosis, multiple uterine myoma)
• The subject is planning pregnancy
• The subject is unable to visit postoperative check-ups
• Refusal from participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy	Procedure: Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy; Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy
Active Comparator: Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy	Procedure: Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy; Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective cure rate	The patient is considered cured if there is no prolapse beyond the hymen and the cervix is above -1 cm according to POP-Q (0-1 stage)	12 months (1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the surgery	Measured through the Patient Global Impression of Improvement questionnaire (PGI-I), validated in Russia. The patient marks the number that best describes her post-operative condition, compared with how it was before surgery. The score ranges from 1 (very much better) to 7 (very much worse).	Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks
The impact of treatment on sexual function	Measured through the scoring of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) validated in Russia. The scale evaluates sexual function in patients with urinary incontinence and/or POP. The responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Items 1 - 4 are reversely scored and a total of 48 is the maximum score. The higher scores indicate better sexual function.	Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks
The impact of treatment on the quality of life	Measured through the Pelvic Floor Disability Index (PFDI-20), validated in Russia. The item includes 20 questions. The score ranges from 0 to 300. The higher the score, the worse the outcome.	Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks
Observed complications	Presence of any adverse effects such as: bleeding requiring blood transfusion, haematoma, organ perforation, nerve injury, vaginal scarring and shortening, wound infection, urinary tract infection, pelvic pain, mesh extrusion in the vagina, mesh erosion into the urinary tract, dyspareunia de novo, de novo urgency, atonic bladder, de novo stress urinary incontinence.	Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks

Collaborators and Investigators

• Sponsor: Saint Petersburg State University, Russia
• Investigators: Study Chair: Dmitry Shkarupa, MD, PhD, Saint Petersburg State University, Russia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: pelvic organ prolapse; vaginal mesh; sacrospinous fixation; vaginal repair; vaginal flap
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: Vaginal flap

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No