Pectopexy for Apical Prolapse Management

NCT06369857 | Recruiting

• 1 other identifier: PPY
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Pelvic Organ Prolapse Quantification stage

  Stage 0 to stage 4

  6 , 12 months

Secondary Outcomes (2)

• Urinary Symptoms questionnaire

  6 , 12 months months

• Bladder neck measurements using Transperineal US

  6 , 12 months

Study Arms (1)

Pectopexy

EXPERIMENTAL

All operations will be performed with patient in loyd davies position, sterilization of the perineum then sterilization of the vagina. Evacuation of the bladder and examination under anesthesia is done. Skin incision through pfannenstiel one then incision of subcutaneous tissue, rectus sheath, separation of recti muscle and opening of parietal peritoneum. A polypropylene mesh (30×30 cm, Ethicon, Inc., Somerville, NJ) is cut to obtain two long arms (15-20 cm long) and a rectangular piece (4-7 cm wide). The mesh is fashioned and fixed over the dissected uterine isthmus and anterior part of the cervix with separated number 1 Prolene and number 1 Vicryl sutures. Peritoneal incision was made from the right round ligament toward the pelvic side wall . The mesh arm is grasped and laterally pulled out So the rectangular part of the mesh will be on the anterior part of the cervix The mesh arms are suspended and sutured to Pectineal liga peritoneum is closed over the mesh

Procedure: Pectopexy

Interventions

Pectopexy PROCEDURE

Suspension of apical organs

Pectopexy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apical prolapse Stage 2-4 acc. to POP-Q system
• Uterine preservation or after hysterectomy
• Age \> 18 years old.
• Sexually active or not.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mohamed Fekry, PhD

CONTACT

0882312388; mohamedbeethoven2040@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obs& Gyn. Specialist of Urogynecology

Model Details: Case series study

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 17, 2024
• Study Start: May 9, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

EG (1)