The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.
Mesh-augmented sacrospinal fixation with posterior colporrhaphy.
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, vaginal repair, vaginal mesh, sacrospinous fixation, colporrhaphy, perineoplasty
Eligibility Criteria
Inclusion Criteria:
- The age of a subject is 45 to 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)
- Patient's ability to read and sign the informed consent form.
- Socialized patient who is able to fill in validated questionnaires and arrive for control postoperative examination in future.
- Patient's consent for participation in the study.
Exclusion Criteria:
- The subject has presence of oncologic disease which was diagnosed earlier or is active now.
- The subject had prior surgery for POP, SUI or hysterectomy
- The subject has gynecological deseases (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 has an active urinary tract infection or skin infection in the region of surgery or acute infectious desease
- The subject is unable to visit postoperative check-ups
- Refusal from participation.
- Bp > C according to POP-Q system.
- gh < 4 cm and > 6 cm according to POP-Q system.
Sites / Locations
- Saint-Petersburg State University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.
Mesh-augmented sacrospinal fixation with posterior colporrhaphy.
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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).
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.
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.
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
Full Information
NCT ID
NCT05422209
First Posted
May 18, 2022
Last Updated
August 2, 2023
Sponsor
Saint Petersburg State University, Russia
1. Study Identification
Unique Protocol Identification Number
NCT05422209
Brief Title
The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
Official Title
The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair. Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
October 9, 2023 (Anticipated)
Study Completion Date
May 9, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Petersburg State University, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective randomized controlled study, designed to assess the influence of posterior colporrhaphy and perineoplasty performed simultaneously with mesh-augmented sacrospinal fixation (apical sling) in advanced pelvic organ prolapse repair.
Detailed Description
BACKGROUND Pelvic organ prolapse (POP) is revealed by the gynecological examination in 40-60 % of parous women. A pelvic floor defect is represented by cystocele almost in a half of cases. At the same time it is known that just the loss of apical support favors going out of the anterior vaginal wall beyond the hymen. Today the vast majority of specialists share one view that the uterus with its sacral-uterine-cardinal ligament complex is a key element for the reliable support of the pelvic floor. It is also considered that perineal body insufficiency promotes the development of POP because the small pelvic organs do not have support on which they could lie. The perineal body is a part of the support level III according to DeLancey. Hiatus enlargement is associated with damage of the elevator muscle of anus and one of the factors for POP development both at a clinical examination and ultrasound scanning. Perineoplasty is one of the methods for correction of hiatus opening and anatomical perineal body insufficiency. An important aspect in POP surgery consists in prevention of a recurrence after the surgical treatment. It is important to mention that today there are no randomized studies comparing the efficiency of transvaginal pelvic floor reconstruction using a mesh for apical fixation with and without the recovery of the support level 3 according to DeLancey. Thus, understanding of mechanisms for prevention of repeated surgeries is fundamental and essential for successful treatment of POP.
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 Our hypothesis is that posterior colporrhaphy and perineoplasty performed simultaneously with mesh-augmented sacrospinal fixation reduces POP recurrence in any compartment.
Taking into account the available data on frequency of recurrences after unilateral sacrospinal fixation according to hybrid technology (7.4 %) and also clinical observation on frequency of recurrences after three-level hybrid reconstruction (1 %), study power of 80 %, significance level of 5 %, 282 patients are necessary to confirm an expected difference in frequency of recurrences. In order to compensate data losses, the calculated sample size was increased by 10 %. As a result, the total sample size is 310 patients.
All enrolled patients will be randomly assigned to mesh-augmented sacrospinal fixation with posterior colporrhaphy or sacrospinal fixation with posterior colporrhaphy and perineoplasty 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 4 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic organ prolapse, vaginal repair, vaginal mesh, sacrospinous fixation, colporrhaphy, perineoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.
Arm Type
Active Comparator
Arm Title
Mesh-augmented sacrospinal fixation with posterior colporrhaphy.
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.
Intervention Description
Vaginal mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.
Intervention Type
Procedure
Intervention Name(s)
Mesh-augmented sacrospinal fixation with posterior colporrhaphy.
Intervention Description
Vaginal mesh-augmented sacrospinal fixation with posterior colporrhaphy.
Primary Outcome Measure Information:
Title
Objective cure rate
Description
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)
Time Frame
24 months (2 years)
Secondary Outcome Measure Information:
Title
Satisfaction with the surgery
Description
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).
Time Frame
Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
Title
The impact of treatment on sexual function
Description
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.
Time Frame
Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
Title
The impact of treatment on the quality of life
Description
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.
Time Frame
Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
Title
Observed complications
Description
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
Time Frame
Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The age of a subject is 45 to 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)
Patient's ability to read and sign the informed consent form.
Socialized patient who is able to fill in validated questionnaires and arrive for control postoperative examination in future.
Patient's consent for participation in the study.
Exclusion Criteria:
The subject has presence of oncologic disease which was diagnosed earlier or is active now.
The subject had prior surgery for POP, SUI or hysterectomy
The subject has gynecological deseases (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 has an active urinary tract infection or skin infection in the region of surgery or acute infectious desease
The subject is unable to visit postoperative check-ups
Refusal from participation.
Bp > C according to POP-Q system.
gh < 4 cm and > 6 cm according to POP-Q system.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rustam Shakhaliev, MD
Phone
+79312368664
Email
rustam.shahaliev@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Suchkov, MD
Phone
+79995218976
Email
denis.suchkov@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Shkarupa, MD, PhD
Organizational Affiliation
Saint Petersburg State University, Russia
Official's Role
Study Chair
Facility Information:
Facility Name
Saint-Petersburg State University Hospital
City
Saint Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rustam Shakhaliev, MD
Phone
+79312368664
Email
rustam.shahaliev@yandex.ru
12. IPD Sharing Statement
Plan to Share IPD
No
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The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
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