Urodynamic Study and Stress Incontinence

NCT ID: NCT03300973

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-15

Study Completion Date

2017-10-31

Brief Summary

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

Detailed Description

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group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.

Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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urodynamics study group

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

Group Type ACTIVE_COMPARATOR

sling surgery

Intervention Type PROCEDURE

transoburator vaginal tape ,inside out procedure under spinal anathesia

surgery only group

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

Group Type ACTIVE_COMPARATOR

sling surgery

Intervention Type PROCEDURE

transoburator vaginal tape ,inside out procedure under spinal anathesia

Interventions

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sling surgery

transoburator vaginal tape ,inside out procedure under spinal anathesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* stress urinary incontinence

Exclusion Criteria

* mixed incontinence
* recurrent cases
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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sarah mohamed hassan

lecturer of obstetrics and gynecology Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr El Ainiy Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sarah M Hassan, lecturer

Role: CONTACT

01003733671

Facility Contacts

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sarah M Hassan, Lecturer

Role: primary

01003733671

Other Identifiers

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11279

Identifier Type: -

Identifier Source: org_study_id