NCT03609229

Brief Summary

Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support. Many women with advanced pelvic organ prolapse who choose to undergo surgical management also choose to undergo continence surgery in order to prevent new onset urinary incontinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

July 25, 2018

Last Update Submit

August 10, 2020

Conditions

Prolapse

Outcome Measures

Primary Outcomes (1)

  • the percentage of stress incontinence post operative

    (symptoms, stress testing, or treatment)

    3 months

Study Arms (2)

Study group

EXPERIMENTAL

Abdominal Sacrocolpopexy with burch technique

Procedure: BurchProcedure: Abdominal Sacrocolpopexy

control group

ACTIVE COMPARATOR

Abdominal Sacrocolpopexy without burch technique

Procedure: Abdominal Sacrocolpopexy

Interventions

BurchPROCEDURE

polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve

Study group
Abdominal SacrocolpopexyPROCEDURE

* By careful dissection (to avoid large veins in this region), expose the back of the pubic bone and the lateral aspects of the urethra. * The right-handed operator double gloves, and places the left hand in the vagina. * With fingers on either side of the catheter in the vagina, define the urethrovesical junction (at the balloon). * Place three Ethibond J-shaped sutures on either side of the urethrovesical junction.

Study groupcontrol group

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Women with 3rd and 4th degree Apical prolapse

You may not qualify if:

  • Patients with previous failed surgical intervention
  • Patients with medical disorders that may interfere with surgical interventions .
  • Patients with apical prolapsed complaining of stress urinary incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

September 1, 2018

Primary Completion

June 30, 2020

Study Completion

August 1, 2020

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

EG(1)