Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized controlled study, designed to compare efficacy and safety of two methods of apical fixation in patients with pelvic organ prolapse (POP) - sacrospinous hysteropexy (SSHP) with synthetic mesh and laparoscopic sacrohysteropexy (LSHP), and the impact of the surgery on quality of life.

Detailed Description
-----------------
BACKGROUND POP remains a widespread condition, that significantly affects patients' quality of life. The estimated incidence of POP in women varies from 10% in young age to 40% after menopause. Apical defect is the least frequent of all types of POP and occurs in 5-15% of patients, however apical support is crucial to maintaining normal anatomy of the pelvic floor. Although the uterus itself is not the cause of POP, hysterectomy is the most common surgery for POP. However there is a growing interest in uterine-sparing surgical techniques because a lot of women express a desire to preserve uterus. There are various techniques for uterine-sparing apical repair, including abdominal (laparoscopic or robotic) and vaginal apical fixation. SSHP is the most studied method of apical fixation and was originally performed with sutures. The use of transvaginal mesh for SSHP is discussable in conjunction with numerous reports of complications and wariness towards synthetic materials use. Some authors though reported of comparable effectiveness and high safety of SSHP using mesh. Due to the lack of the reliable evidence, to date there are no consensus about optimal method of hysteropexy, as LSHP is not without its drawbacks and complications. 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 SSHP is non-inferior to LSHP in terms of recurrence rate and complications. The sample size was calculated assuming an objective cure rate of 92% as described in literature. With a power of 80%, a level of 0,05 and the non-inferiority margin at 15%, the sample size is 92 patients. The investigators assume a drop-out rate of 10%, thus a total of 102 participants will be included in the study. All enrolled patients will be randomly assigned to SSHP or LSHP 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, 12 and 24 months after surgery by 2 researchers, who will be blinded about the type of intervention.

Official Title
-----------------
Comparison the Effectiveness and Safety of Vaginal and Laparoscopic Apical Fixation Techniques Using a Synthetic Mesh for Pelvic Organ Prolapse Treatment. A Randomized Controlled Study

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: Vaginal
* Procedure: Laparoscopic


Participation Criteria
=================
Eligibility Criteria
-----------------
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>=0 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 surgery for POP, stress urinary incontinence (SUI) or hysterectomy The subject has history of pelvic cancer The subject has chronic pelvic pain The subject has cervical elongation The subject has severe obesity (BMI > 30) The subject has postoperative scars/suspected adhesions in the ares of surgical access to the abdomen The subject has gynecological diseases (recurrent uterine bleeding, endometrial hyperplasia, the presence of atypical cells in cervical smears, adenomyosis, multiple uterine myoma) The subject has urinary incontinence The subject is planning pregnancy The subject is unable to visit postoperative check-ups Refusal from participation.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sacrospinous fixation of the vaginal apex with the synthetic mesh<br> | Procedure: Vaginal<br>* Sacrospinous hysteropexy using the synthetic mesh<br>|
| Active Comparator: Laparoscopic sacrocolpopexy<br> | Procedure: Laparoscopic<br>* Laparoscopic Sacrohysteropexy<br>|

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) | 24 months (2 years) | 

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 and 24 months postoperatively | 
| 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 and 24 months postoperatively | 
| 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 and 24 months postoperatively | 
| 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 and 24 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sacrohysteropexy, pelvic organ prolapse, apical prolapse, vaginal repair, vaginal mesh, sacrospinous fixation