NCT03300973

Brief Summary

A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 15, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
Last Updated

October 4, 2017

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

September 21, 2017

Last Update Submit

September 28, 2017

Conditions

Stress Urinary Incontinence

Keywords

urodynamic studystress urinary incontinence

Outcome Measures

Primary Outcomes (1)

  • cure of stress incontinence

    by clinical assessment

    1 week after surgery

Secondary Outcomes (2)

  • cure of stress incontinence

    one month after surgery

  • cure of stress incontinence

    3 months after surgery

Study Arms (2)

urodynamics study group

ACTIVE COMPARATOR

65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery

Procedure: sling surgery

surgery only group

ACTIVE COMPARATOR

60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study

Procedure: sling surgery

Interventions

sling surgeryPROCEDURE

transoburator vaginal tape ,inside out procedure under spinal anathesia

surgery only groupurodynamics study group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • stress urinary incontinence

You may not qualify if:

  • mixed incontinence
  • recurrent cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Sarah M Hassan, lecturer

CONTACT

01003733671saramohamed7880@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology Cairo university

Study Record Dates

First Submitted

September 21, 2017

First Posted

October 4, 2017

Study Start

January 15, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 4, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)