NCT03489902

Brief Summary

Clinical trial comparing the new technique for paravaginal repair versus the traditional technique

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

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

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

March 28, 2018

Last Update Submit

April 6, 2018

Conditions

Cystocele

Outcome Measures

Primary Outcomes (1)

  • Operative data

    Operative time

    1 day

Secondary Outcomes (2)

  • Pelvic organ prolapse quantification system

    3 month

  • Operative Details

    1 day

Study Arms (2)

Transobturator arm

EXPERIMENTAL

Transobturator Paravaginal Repair

Procedure: Transobturator Paravaginal Repair

Transvaginal arm

EXPERIMENTAL

traditional transvaginal Paravaginal Repair

Procedure: traditional transvaginal Paravaginal Repair

Interventions

Transobturator Paravaginal RepairPROCEDURE

Transobturator application of sutures to the white line in cases needing paravaginal repair

Transobturator arm
traditional transvaginal Paravaginal RepairPROCEDURE

traditional transvaginal application of sutures to the white line

Transvaginal arm

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • paravaginal defect cystocele
  • midline and paravaginal defect cystocele

You may not qualify if:

  • uterine descent previous cystocele surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hamdy HA Saaid, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow of obstetrics & gynecology

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 6, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2017

Study Completion

March 1, 2018

Last Updated

April 9, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share