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Status unknownNCT03300973Updated Oct 4, 2017

Urodynamic Study and Stress Incontinence

A Phase 2 interventional study of sling surgery in Stress Urinary Incontinence, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-10-04.

Sponsored by Kasr El Aini Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Stress Urinary Incontinence

Keywords

  • urodynamic study
  • stress urinary incontinence
03

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • stress urinary incontinence

Exclusion criteria

Exclusion Criteria:

  • mixed incontinence
  • recurrent cases
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
125 participants (estimated)

Study arms

  • Active comparator
    urodynamics study group

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

    Procedure: sling surgery

  • Active comparator
    surgery only group

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

    Procedure: sling surgery

Interventions

  • Proceduresling surgery

    transoburator vaginal tape ,inside out procedure under spinal anathesia

05

What researchers measure

Primary outcomes

  1. cure of stress incontinence

    by clinical assessment

    Time frame: 1 week after surgery

Secondary outcomes

  1. cure of stress incontinence

    by clinical assessment

    Time frame: one month after surgery

  2. cure of stress incontinence

    by clinical assessment

    Time frame: 3 months after surgery

06

Study locations

1 of 1 sites recruiting
  • Kasr El Ainiy Hospital
    Cairo, 11562, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03300973
Lead sponsor
Kasr El Aini Hospital
Responsible party
sarah mohamed hassan (lecturer of obstetrics and gynecology Cairo university, Kasr El Aini Hospital) — Principal investigator
First posted
Oct 4, 2017
Start date
Jan 15, 2016
Primary completion
Oct 2017 (estimated)
Completion
Oct 2017 (estimated)
Last update
Oct 4, 2017

Study contacts

Sarah M Hassan, lecturer
Contact
saramohamed7880@yahoo.com
01003733671

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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