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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06369857
Other study ID # PPY
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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