NCT02735772

Brief Summary

A new technique for Applying sutures to the white line in paravaginal repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

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

March 31, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

March 31, 2016

Last Update Submit

October 4, 2019

Conditions

Cystocele

Outcome Measures

Primary Outcomes (1)

  • success rate

    Evaluation of the postoperative degree of anterior vaginal wall descent using pelvic organ prolapse quantitative system

    6 months

Secondary Outcomes (4)

  • lateral vaginal fornices elevation

    3 month

  • Operative time

    1 day

  • Intraoperative blood loss

    1 day

  • Complications rate

    1 week

Study Arms (1)

cystocele

OTHER

Arm: Patients with paravaginal defect cystocele Intervention: transobturator approach for paravaginal repair

Procedure: transobturator approach for paravaginal repair

Interventions

transobturator approach for paravaginal repairPROCEDURE

using TOT needle to apply suturs to white line

cystocele

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
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

Study Sites (1)

Urogynecology Unit

Cairo, Egypt

Location

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

  • Hazem SH Samoor, Professor

    Ain Shams Universty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All Patients included in the study will undergo repair of paravaginal defect using tge new technique described in this study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Hamdy Ahmed

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 13, 2016

Study Start

April 25, 2017

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)