NCT03772691

Brief Summary

Pelvic organ prolapse (POP) is considered one of the commonest gynecologic health problems all over the world. Pelvic organ prolapse (POP) is common and can be seen in up to 50% or more of parous women. The annual aggregated rate of associated surgery for pelvic organ prolapse is in the range of 10-30 per 10,000 women. It is estimated that women have an 11-19% life-time risk of undergoing surgery for POP. This rate is projected to increase over the next 2-3 decades. Apical POP refers any descent of the cervix or the vaginal cuff scar(as after hysterectomy) below a point which is 2 cm less than the total vaginal length about the plane of the hymen. Apical POP is due to defect in apical support with damage to the cardinal and uterosacral ligaments. Apical pelvic organ prolapse is a common issue in our country with significant incidence rate due to many predisposing factors including increasing age, higher gravidity and parity (especially the number of vaginal births)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

2.9 years

First QC Date

December 9, 2018

Last Update Submit

January 27, 2022

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

  • rate of occurance of denovo stress urinary incontinence

    number of patients developed new onset postoperative stress urinary incontinence

    18 months

  • The rate of Improvement of urinary symptoms

    Improvement of symptoms using Abramsc Development and psychometric evaluation of the International consultation on incontinence and Vaginal Symptoms Questionnaire maximum score:178, minimum score:0 high score means better outcome , low score means worse outcome

    18 months

Secondary Outcomes (2)

  • objective assessment of prolapse stage

    18 months

  • assessment of sexual function

    18 months

Study Arms (2)

lateral suspension

EXPERIMENTAL

All operations will be performed with patient in loyd davies position, sterilization of the perineum then sterilization of the vagina

Procedure: lateral suspension

sacropexy

ACTIVE COMPARATOR

Our first passage is the peritoneum incision overlying the sacral promontory (L5-S1) to expose the anterior longitudinal ligament, which is the anchorage point of the mesh on the sacrum. We create a tunnel under the peritoneum on the right side through the cul-de-sac of Douglas till reach the cervix or vaginal cuff (after hysterectomy).

Procedure: sacropexy

Interventions

lateral suspensionPROCEDURE

• The vesico-vaginal space was found between the bladder and the anterior vaginal wall in the fascia plane. A polypropylene mesh (25 , 25 cm, Ethicon, Inc., Somerville, NJ) was cut to obtain two long arms (15-20 mm wide) and a rectangular piece (4-7 cm wide).

lateral suspension
sacropexyPROCEDURE

• The mesh is fixed on the anterior longitudinal ligament of sacrum with separated number 1 prolene sutures. The other end of the mesh is passed through the peritoneal tunnel and fixed to the cervix using prolene 1 and vicryl o sutures.

sacropexy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apical prolapse Stage 2-4 according to POP-Q system
  • Uterine preservation or after hysterectomy
  • 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.
  • Urge incontinence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related Publications (1)

  • Sayed E, Mitwally A, Abdelmagied A, Fetih A, Fekry M. Transperineal Ultrasound Evaluation of Bladder Parameters in Patients with Apical Prolapse Undergoing Lateral Suspension or Sacropexy. J Obstet Gynaecol India. 2024 Apr;74(2):170-175. doi: 10.1007/s13224-023-01912-2. Epub 2023 Dec 19.

    PMID: 38707876DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 9, 2018

First Posted

December 11, 2018

Study Start

January 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 7, 2022

Record last verified: 2022-01

Locations

EG(1)