Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Vaginal
Laparoscopic
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring sacrohysteropexy, pelvic organ prolapse, apical prolapse, vaginal repair, vaginal mesh, sacrospinous fixation
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.
Sites / Locations
- Saint-Petersburg State University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sacrospinous fixation of the vaginal apex with the synthetic mesh
Laparoscopic sacrocolpopexy
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
NCT05420831
First Posted
May 18, 2022
Last Updated
August 2, 2023
Sponsor
Saint Petersburg State University, Russia
1. Study Identification
Unique Protocol Identification Number
NCT05420831
Brief Title
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
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
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
August 2, 2023 (Actual)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
sacrohysteropexy, pelvic organ prolapse, apical prolapse, vaginal repair, vaginal mesh, sacrospinous fixation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sacrospinous fixation of the vaginal apex with the synthetic mesh
Arm Type
Active Comparator
Arm Title
Laparoscopic sacrocolpopexy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Vaginal
Intervention Description
Sacrospinous hysteropexy using the synthetic mesh
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic
Intervention Description
Laparoscopic Sacrohysteropexy
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Suchkov, MD
Phone
+79995218976
Email
denis.urolog@yandex.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Rustam Shakhaliev, MD
Phone
+79312368664
Email
rustam.shahaliev@gmail.com
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
Denis Suchkov, MD
Phone
+79995218976
Email
denis.urolog@yandex.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
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