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Pectopexy for Apical Prolapse Management

Pectopexy for Treatment of Apical Pelvic Organ Prolapse

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06369857
Enrollment
10
Registered
2024-04-17
Start date
2024-05-09
Completion date
2025-08-31
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Brief 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

Detailed 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.

Interventions

PROCEDUREPectopexy

Suspension of apical organs

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Case series study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pelvic Organ Prolapse Quantification stage6 , 12 monthsStage 0 to stage 4

Secondary

MeasureTime frameDescription
Urinary Symptoms questionnaire6 , 12 months monthsQuestions about urinary system before and after surgery
Bladder neck measurements using Transperineal US6 , 12 monthsBladder neck height in millimeters

Countries

Egypt

Contacts

Primary ContactMohamed Fekry, PhD
mohamedbeethoven2040@gmail.com0882312388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026