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Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy

Primary Purpose

Pelvic Organ Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laparoscopic lateral suspension
laparoscopic pectopexy
Sacrospinous ligament fixation
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 other trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, apical prolapse, pectopexy, sacrospinous ligament fixation, Lateral suspension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female with genital prolapse Exclusion Criteria: Patients who had pouch of Douglas obliteration Patients with enterocele Patients who have any congenital or acquired anatomic and reproductive anomaly

Sites / Locations

  • Cemil Taşcıoğlu HospitalRecruiting
  • Prof.Dr.Cemil Taşcıoğlu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

No Intervention

No Intervention

Arm Label

lateral suspension

pectopexy

sacrospinous ligament fixation

hysterectomized patients

Nulliparous women

Arm Description

Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. Preoperative and postoperative MRI results were evaluated

The cervix or vaginal cuff was suspended by the Cooper ligament.Preoperative and postoperative MRI results were evaluated

vaginal cuff/uterus was sutured to the unilateral sacrospinous ligament.Preoperative and postoperative MRI results were evaluated

Vaginal axis MRI of women who have previously been hysterectomized and who do not have apical prolapse

MRI of nulliparous women was evaluated for vaginal axis.

Outcomes

Primary Outcome Measures

Vaginal axis
From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated.
Vaginal distances
The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.

Secondary Outcome Measures

Prolapse symptoms, Colorectal-Anal Impact Questionnaire
The Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) consists of three scales of seven questions, each taken from the Urinary Incontinence Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The three scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300) describes the impact on day to day activities. It is useful to determine changes in symptom-severity over time and before and after treatments
Prolapse symptoms
The Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20) measures both pelvic floor symptoms and the degree of bother and distress associated with those symptoms. The PFDI-20 includes 20 questions and three scales. Each of the three scales is scored from 0 (least distress) to 100 (greatest distress), again with an overall score ranging from 0-300 and higher scores indicating lower quality of life. The three scales include questions taken from the Urogenital Distress Inventory-6 questions, the Pelvic Organ Prolapse Distress Inventory-6 questions, and the Colorectal-Anal Distress Inventory-8 questions.
Urinary Symptoms
Validated scales were applied for this purpose, including the urogenital distress inventory-6 (UDI-6), which is a shortened version of a condition-specific quality of life instrument. The UDI-6 is frequently used due to its feasibility and is validated at level A according to the International Continence Society (ICI) grading system. The UDI-6 scale includes six items that assess various aspects of urinary symptoms and their impact on daily life. These items include: 1) Frequent urination, 2) Leakage related to the feeling of urgency, 3) Leakage related to activity, 4) Coughing or sneezing small amounts of leakage (drops), 5) Difficulty emptying the bladder, and 6) Pain or discomfort in the lower abdominal or genital area. Higher scores on the UDI-6 indicate a higher level of disability in these areas.
Postoperative de novo dyspareunia
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) Postoperative de novo dyspareunia assessed by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) with main focus on Question 5, which represents how the participant feels about her sex life (I feel frustrated by my sex life/I feel sexually inferior because of my incontinence and/or prolapse/I feel angry because of the impact that incontinence and/or prolapse has on my sex life)
Sexual functions
The Female Sexual Function Index (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 that 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.
Quality of life measures
General health Short Form Health Survey (SF-12) Form includes two questions concerning physical functioning; two questions on role limitations due to physical health problems; one question on bodily pain; one question on general health perceptions; one question on vitality (energy/fatigue); one question on social functioning; two questions on role limitations due to emotional problems; and two questions on general mental health (psychological distress and psychological well-being
Patient Global Impression of Improvement (PGI-I)
Patient Global Impression of Improvement (PGI-I). A low score on the PGI-I indicates an overall improvement in a woman's perception of her condition after treatment (PGI-I score of 1 or 2 = very much better and much better, respectively

Full Information

First Posted
October 3, 2023
Last Updated
October 10, 2023
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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1. Study Identification

Unique Protocol Identification Number
NCT06072456
Brief Title
Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy
Official Title
Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (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
Sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically. Nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced age constrain the advantages conferred by the procedure. Recent years have witnessed a proliferation of inquiries appraising the efficacy of laparoscopic lateral suspension, pectopexy, and sacrospinous ligament fixation interventions, which have, over time, garnered extensive clinical application, in relation to recurrence rates. A multitude of investigations have been undertaken to delineate the optimal vaginal axis. In the present investigation, we have delineated a research protocol aimed at scrutinizing these alternative surgical modalities with regard to their impact on the vaginal axis.
Detailed Description
The study objective pertains to the assessment of vaginal axis in patients undergoing apical prolapse surgery, whether they have undergone hysterectomy or not. The investigation is designed to test the null hypothesis by means of a comparative analysis of preoperative and postoperative Magnetic Resonance Imaging images capturing the vaginal axis. This examination will be conducted on patients slated to receive lateral mesh suspension, pectopexy, and sacrospinous ligament fixation procedures for the correction of apical prolapse.

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, apical prolapse, pectopexy, sacrospinous ligament fixation, Lateral suspension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lateral suspension
Arm Type
Experimental
Arm Description
Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. Preoperative and postoperative MRI results were evaluated
Arm Title
pectopexy
Arm Type
Experimental
Arm Description
The cervix or vaginal cuff was suspended by the Cooper ligament.Preoperative and postoperative MRI results were evaluated
Arm Title
sacrospinous ligament fixation
Arm Type
Experimental
Arm Description
vaginal cuff/uterus was sutured to the unilateral sacrospinous ligament.Preoperative and postoperative MRI results were evaluated
Arm Title
hysterectomized patients
Arm Type
No Intervention
Arm Description
Vaginal axis MRI of women who have previously been hysterectomized and who do not have apical prolapse
Arm Title
Nulliparous women
Arm Type
No Intervention
Arm Description
MRI of nulliparous women was evaluated for vaginal axis.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic lateral suspension
Intervention Description
Lateral suspension involves the lateral attachment or suspension of vaginal tissue to a stable structure, often using mesh or sutures, to provide support and stability to the pelvic organs. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic pectopexy
Intervention Description
Pectopexy involves attaching or suspending the vaginal vault to the pectineal ligament, which is a strong ligament in the pelvis. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women.
Intervention Type
Procedure
Intervention Name(s)
Sacrospinous ligament fixation
Intervention Description
Sacrospinous ligament fixation entails the attachment or fixation of the vaginal vault to the sacrospinous ligament, which is a strong fibrous band located in the pelvis
Primary Outcome Measure Information:
Title
Vaginal axis
Description
From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated.
Time Frame
at 4th months after the operation
Title
Vaginal distances
Description
The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.
Time Frame
at 4th months after the operation
Secondary Outcome Measure Information:
Title
Prolapse symptoms, Colorectal-Anal Impact Questionnaire
Description
The Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) consists of three scales of seven questions, each taken from the Urinary Incontinence Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The three scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300) describes the impact on day to day activities. It is useful to determine changes in symptom-severity over time and before and after treatments
Time Frame
at 4th months after the operation
Title
Prolapse symptoms
Description
The Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20) measures both pelvic floor symptoms and the degree of bother and distress associated with those symptoms. The PFDI-20 includes 20 questions and three scales. Each of the three scales is scored from 0 (least distress) to 100 (greatest distress), again with an overall score ranging from 0-300 and higher scores indicating lower quality of life. The three scales include questions taken from the Urogenital Distress Inventory-6 questions, the Pelvic Organ Prolapse Distress Inventory-6 questions, and the Colorectal-Anal Distress Inventory-8 questions.
Time Frame
at 4th months after the operation
Title
Urinary Symptoms
Description
Validated scales were applied for this purpose, including the urogenital distress inventory-6 (UDI-6), which is a shortened version of a condition-specific quality of life instrument. The UDI-6 is frequently used due to its feasibility and is validated at level A according to the International Continence Society (ICI) grading system. The UDI-6 scale includes six items that assess various aspects of urinary symptoms and their impact on daily life. These items include: 1) Frequent urination, 2) Leakage related to the feeling of urgency, 3) Leakage related to activity, 4) Coughing or sneezing small amounts of leakage (drops), 5) Difficulty emptying the bladder, and 6) Pain or discomfort in the lower abdominal or genital area. Higher scores on the UDI-6 indicate a higher level of disability in these areas.
Time Frame
at 4th months after the operation
Title
Postoperative de novo dyspareunia
Description
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) Postoperative de novo dyspareunia assessed by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) with main focus on Question 5, which represents how the participant feels about her sex life (I feel frustrated by my sex life/I feel sexually inferior because of my incontinence and/or prolapse/I feel angry because of the impact that incontinence and/or prolapse has on my sex life)
Time Frame
at 4th months after the operation
Title
Sexual functions
Description
The Female Sexual Function Index (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 that 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
at 4th months after the operation
Title
Quality of life measures
Description
General health Short Form Health Survey (SF-12) Form includes two questions concerning physical functioning; two questions on role limitations due to physical health problems; one question on bodily pain; one question on general health perceptions; one question on vitality (energy/fatigue); one question on social functioning; two questions on role limitations due to emotional problems; and two questions on general mental health (psychological distress and psychological well-being
Time Frame
at 4th months after the operation
Title
Patient Global Impression of Improvement (PGI-I)
Description
Patient Global Impression of Improvement (PGI-I). A low score on the PGI-I indicates an overall improvement in a woman's perception of her condition after treatment (PGI-I score of 1 or 2 = very much better and much better, respectively
Time Frame
at 4th months after the operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female with genital prolapse Exclusion Criteria: Patients who had pouch of Douglas obliteration Patients with enterocele Patients who have any congenital or acquired anatomic and reproductive anomaly
Facility Information:
Facility Name
Cemil Taşcıoğlu Hospital
City
Istanbul
ZIP/Postal Code
34320
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
fatih şahin, md
Phone
5447430167
Ext
344
Email
fatih_sahin67@hotmail.com
First Name & Middle Initial & Last Name & Degree
fatih şahin, md
Facility Name
Prof.Dr.Cemil Taşcıoğlu Hospital
City
Istanbul
ZIP/Postal Code
34320
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
fatih şahin, md
Phone
5447430167
Email
fatih_sahin67@hotmail.com
First Name & Middle Initial & Last Name & Degree
fatih şahin

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28816554
Citation
Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.
Results Reference
result
PubMed Identifier
33175232
Citation
Pulatoglu C, Yassa M, Turan G, Turkyilmaz D, Dogan O. Vaginal axis on MRI after laparoscopic lateral mesh suspension surgery: a controlled study. Int Urogynecol J. 2021 Apr;32(4):851-858. doi: 10.1007/s00192-020-04596-8. Epub 2020 Nov 11.
Results Reference
result

Learn more about this trial

Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy

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