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

NCT05876975 | Unknown

• 1 other identifier: 77
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Pelvic Organ Prolapse

Keywords

Magnetic resonance imaging (MRI); vaginal angle; vaginal axis; pelvic organ prolapse (POP)

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (2)

• Urge Symptoms stres incontinence

  3 month

• Sexual functions

  3 month

Study Arms (2)

procedure: laparoscopic pectopexy

ACTIVE COMPARATOR

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

Procedure: laparoscopic pectopexy

Nulliparous women with no uterovaginal prolapsed

NO INTERVENTION

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

Interventions

laparoscopic pectopexy PROCEDURE

Women with pelvic organ prolapse and suitable indications underwent laparoscopic pectopexy.

procedure: laparoscopic pectopexy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 35571410 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• fatih şahin, MD

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatih Şahin, MD

CONTACT

+905447430167; fatih_sahin67@hotmail.com

Murat i Toplu, MD

CONTACT

+905317262517; mitoplu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD / Principal Investigator

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 26, 2023
• Study Start: January 4, 2023
• Primary Completion: June 4, 2023
• Study Completion: July 1, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)