Pectopexy for Apical Prolapse Management

Pelvic Organ Prolapse Clinical Trial

Official title:

Pectopexy for Treatment of Apical Pelvic Organ Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369857
• Other study ID #: PPY
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Mohamed Fekry, PhD
• Phone: 0882312388
• Email: mohamedbeethoven2040[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to evaluate the efficacy of pectopexy for treatment of apical pelvic organ prolapse at follow up at 12 months. Investigator also evaluates complications, improvement of symptoms, quality-of-life outcomes and patient satisfaction with surgery.

Assessment of restoration of normal pelvic anatomy and lower urinary tract symptoms using transperineal ultrasound

Description:

Pelvic organ prolapse (POP) substantially affects the quality of life (QOL) of women, with a global prevalence of 20% to 65% .Surgery is the major treatment option for patients with POP at POP Quantification (POP-Q) stage ≥II, especially after failure of conservative treatments . Apical pelvic organ prolapse is a common issue in Egypt with significant incidence rate due to many predisposing factors including increasing age, higher gravidity and parity (especially the number of vaginal births .

Apical support is the most important factor for the successful outcome of pelvic reconstruction surgery. Apical suspension can be performed transabdominally or transvaginally using native tissue or a synthetic mesh . Abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse . However , many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases. Postoperative complications include paralytic ileus in 3.6%.transient femoral nerve injury and vertebral osteomyelitis . Sacropexy also has a long steep learning curve .

Pectopexy has been in 2011 where synthetic mesh is fixed to the pectineal ligaments bilaterally.This surgery is presumed to have fewer complications because the surgical field is limited to the anterior pelvis, with a decreased risk of injury to the adjacent organs. The technique is suitable for surgeons seeking an attractive alternative for patients in a context of high morbidity and/or with difficult access to the promontory . However, adequate evidence to support this surgical option still needs further studies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Apical prolapse Stage 2-4 acc. to POP-Q system

• Uterine preservation or after hysterectomy

• Age > 18 years old.

• Sexually active or not.

Exclusion Criteria:

• Pregnancy or up to 6 months postpartum.

• Current Urinary tract infection proved by urine analysis or urine culture.

• Patient unfit for surgery.

• Previous suspension operations.

• Uncontrolled diabetic patients

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Pectopexy
Suspension of apical organs

Locations

Country	Name	City	State
Egypt	Women Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Organ Prolapse Quantification stage	Stage 0 to stage 4	6 , 12 months
Secondary	Urinary Symptoms questionnaire	Questions about urinary system before and after surgery	6 , 12 months months
Secondary	Bladder neck measurements using Transperineal US	Bladder neck height in millimeters	6 , 12 months