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Vaginal Axis on Magnetic Resonance Imaging After Laparoscopic Pectopexy Surgery: a Controlled Study

Primary Purpose

Pelvic Organ Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laparoscopic pectopexy
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Magnetic resonance imaging (MRI), vaginal angle, vaginal axis, pelvic organ prolapse (POP)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

In Intervention Group Inclusion Criteria: Women diagnosed with apical pelvic organ prolapse (POP), who did not require an additional posterior colporrhaphy procedure, and desired to undergo uterus-preserving surgery were scheduled for laparoscopic pectopexy. Exclusion Criteria: Women with uterine size greater than 10 cm or a pelvic mass that may alter or interfere with accurate measurement. Women with any congenital or acquired anatomical or reproductive anomaly. Women diagnosed with enterocele through transperineal ultrasound prior to enrollment. Women who require hysterectomy or concomitant pelvic organ prolapse (POP) or anti- incontinence procedure. Women with abnormal uterine bleeding. Women with abnormal cervical screening test results. In Control Group Inclusion Criteria: Nulliparous women without pelvic organ prolapse (asymptomatic grade 1 or less) who presented to the outpatient clinic with complaints other than POP symptoms (e.g., menstrual irregularity) were randomly selected and assigned as the control group. Exclusion Criteria: Women who have given birth previously. Women with a history of pelvic organ prolapse or any pelvic floor disorders. Women who have undergone pelvic surgery. Women with any congenital or acquired anatomical or reproductive anomaly. Women with abnormal uterine bleeding. Women with abnormal cervical screening test results.

Sites / Locations

  • Prof. Dr. Cemil Taşcıoğlu City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

procedure: laparoscopic pectopexy

Nulliparous women with no uterovaginal prolapsed

Arm Description

MRI evaluation will be conducted on eleven participants who underwent laparoscopic pectopexy surgery after one month.

Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI

Outcomes

Primary Outcome Measures

Anatomic Success
anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane

Secondary Outcome Measures

Urge Symptoms stres incontinence
UDI-6 Th e UDI-6 was developed to evaluate the functions of the bladder and to establish which symptom causes the problem. It comprises 6 questions. Th e fi rst 2 questions are related to irritative symptoms (urgency, frequency, and pain), questions 3 and 4 are related to stress incontinence, and the last 2 questions are related to obstructive or voiding diffi culty symptoms. High UDI-6 scores show the severity of the urogenital complaints
Sexual functions
The FSFI evaluates sexual functioning in women and comprises of 19 questions with different answer choice scales referring the sexual life in the previous 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter, there is a threshold at 26.55 which means tFhat all values below are classed as indicating female sexual dysfunction (FSD). The domain scores are obtained as the sum of points attributed to questions in that domain multiplied by the domain factor.

Full Information

First Posted
May 11, 2023
Last Updated
May 17, 2023
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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1. Study Identification

Unique Protocol Identification Number
NCT05876975
Brief Title
Vaginal Axis on Magnetic Resonance Imaging After Laparoscopic Pectopexy Surgery: a Controlled Study
Official Title
Vaginal Axis on MRI After Laparoscopic Pectopexy Surgery: a Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
June 4, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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
Pelvic organ prolapse (POP) is a major public health concern that adversely affects the physical and psychological well-being of women. In fact, the lifetime risk of POP surgery is 12.6%, highlighting the magnitude of the problem. The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse. The primary objective of surgical treatment for POP is to mitigate symptoms and restore the pelvic support anatomy. Normally, the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae, lying relatively horizontally to the levator plate, and forming an angle of about 130º between the middle and lower vagina. Although sacrocolpopexy (SCP) is considered the gold standard for treating POP, it alters the normal anatomical position of the vaginal axis towards the sacral promontory, which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse. Similarly, sacrospinous ligament fixation (SSLF) increases the risk of anterior vaginal wall prolapse, as it deviates the vaginal axis towards the posterior. However, laparoscopic lateral mesh suspension has recently become popular because it preserves the normal position of the vaginal axis, preventing such complications. A previous study found that the pectineal ligament (Cooper's ligament) is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis. This structure is robust and can hold sutures well, and it is possible to find sufficient material for a suture in the lateral part of the iliopectineal ligament, facilitating pelvic floor reconstruction. This segment of the ligament is located at the second sacral vertebra (S2) level, which is the optimal level for the physiological axis of the vagina. S2 level serves as the anchor point for the physiological axis of the vagina. Further studies have demonstrated that laparoscopic pectopexy provides outcomes comparable to those of laparoscopic sacrocolpopexy for supporting the apical compartment during intermediate follow-up duration. The current study aimed to investigate the level of anatomical correction following laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging (MRI).
Detailed Description
Pelvic organ prolapse (POP) is a significant health concern that has a negative impact on the physical and psychological well-being of women. In fact, the lifetime risk of undergoing POP surgery is 12.6%. The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse. The primary goal of surgical treatment for POP is to alleviate symptoms and restore the anatomy of the pelvic support. The normal position of the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae, lying relatively horizontally to the levator plate, and forming an angle of about 130º between the middle and lower vagina. Sacrocolpopexy (SCP) is considered the gold standard for treating POP, but it alters the normal anatomical position of the vaginal axis towards the sacral promontory, which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse. Although sacrospinous ligament fixation (SSLF) has promising long-term outcomes for correcting the apical anatomy, it increases the risk of anterior vaginal wall prolapse, like SCP, due to the deviation of the vaginal axis towards the posterior. Recently, laparoscopic lateral mesh suspension, which keeps the vaginal axis close to normal, has become popular. In a previous study, it was found that the pectineal ligament (Cooper's ligament) is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis. This structure is robust and can hold sutures well. Sufficient material for a suture can also be found in the lateral part of the iliopectineal ligament, making pelvic floor reconstruction easier. This segment of the ligament is located at the second sacral vertebra (S2) level, which is the optimal level for the physiological axis of the vagina. S2 level is the anchor point for the physiological axis of the vagina. Further studies have demonstrated comparable outcomes for supporting the apical compartment at intermediate follow-up duration compared to laparoscopic sacrocolpopexy. This study aimed to investigate the level of anatomical correction following Laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging (MRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Magnetic resonance imaging (MRI), vaginal angle, vaginal axis, pelvic organ prolapse (POP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
procedure: laparoscopic pectopexy
Arm Type
Active Comparator
Arm Description
MRI evaluation will be conducted on eleven participants who underwent laparoscopic pectopexy surgery after one month.
Arm Title
Nulliparous women with no uterovaginal prolapsed
Arm Type
No Intervention
Arm Description
Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI
Intervention Type
Procedure
Intervention Name(s)
laparoscopic pectopexy
Intervention Description
Women with pelvic organ prolapse and suitable indications underwent laparoscopic pectopexy.
Primary Outcome Measure Information:
Title
Anatomic Success
Description
anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Urge Symptoms stres incontinence
Description
UDI-6 Th e UDI-6 was developed to evaluate the functions of the bladder and to establish which symptom causes the problem. It comprises 6 questions. Th e fi rst 2 questions are related to irritative symptoms (urgency, frequency, and pain), questions 3 and 4 are related to stress incontinence, and the last 2 questions are related to obstructive or voiding diffi culty symptoms. High UDI-6 scores show the severity of the urogenital complaints
Time Frame
3 month
Title
Sexual functions
Description
The FSFI evaluates sexual functioning in women and comprises of 19 questions with different answer choice scales referring the sexual life in the previous 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter, there is a threshold at 26.55 which means tFhat all values below are classed as indicating female sexual dysfunction (FSD). The domain scores are obtained as the sum of points attributed to questions in that domain multiplied by the domain factor.
Time Frame
3 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
In Intervention Group Inclusion Criteria: Women diagnosed with apical pelvic organ prolapse (POP), who did not require an additional posterior colporrhaphy procedure, and desired to undergo uterus-preserving surgery were scheduled for laparoscopic pectopexy. Exclusion Criteria: Women with uterine size greater than 10 cm or a pelvic mass that may alter or interfere with accurate measurement. Women with any congenital or acquired anatomical or reproductive anomaly. Women diagnosed with enterocele through transperineal ultrasound prior to enrollment. Women who require hysterectomy or concomitant pelvic organ prolapse (POP) or anti- incontinence procedure. Women with abnormal uterine bleeding. Women with abnormal cervical screening test results. In Control Group Inclusion Criteria: Nulliparous women without pelvic organ prolapse (asymptomatic grade 1 or less) who presented to the outpatient clinic with complaints other than POP symptoms (e.g., menstrual irregularity) were randomly selected and assigned as the control group. Exclusion Criteria: Women who have given birth previously. Women with a history of pelvic organ prolapse or any pelvic floor disorders. Women who have undergone pelvic surgery. Women with any congenital or acquired anatomical or reproductive anomaly. Women with abnormal uterine bleeding. Women with abnormal cervical screening test results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Şahin, MD
Phone
+905447430167
Email
fatih_sahin67@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Murat i Toplu, MD
Phone
+905317262517
Email
mitoplu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatih şahin, MD
Organizational Affiliation
Prof. Dr. Cemil Tascıoglu City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Dr. Cemil Taşcıoğlu City Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
pelin ilhan
Phone
+902123145555
Ext
10057
Email
stratejicemiltascioglu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35571410
Citation
Wang H, Shen J, Li S, Gao Z, Ke K, Gu P. The feasibility of uterine-vaginal axis MRI-based as evaluation of surgical efficacy in women with pelvic organ prolapse. Ann Transl Med. 2022 Apr;10(8):447. doi: 10.21037/atm-22-1173.
Results Reference
background

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Vaginal Axis on Magnetic Resonance Imaging After Laparoscopic Pectopexy Surgery: a Controlled Study

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