Clinical trial NCT06369857: Pectopexy for Apical Prolapse Management
Official title: Pectopexy for Treatment of Apical Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification stage
timeFrame: 6 , 12 months
Secondary outcomes:
measure: Urinary Symptoms questionnaire
timeFrame: 6 , 12 months months
measure: Bladder neck measurements using Transperineal US
timeFrame: 6 , 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital
Study officials:
References: