CompletedNCT03296748Updated Oct 24, 2017

Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence

A Phase 2/3 interventional study of trans-obturator tape inside-out usingsoft tapes. and anterior colporraphy in Stress Urinary Incontinence, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to female participants aged 23 Years to 56 Years. Per ClinicalTrials.gov, last updated 2017-10-24.

Sponsored by Kasr El Aini Hospital · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 123
Allocation: Non-randomized
Ages: 23 Years to 56 Years
Sex: Female

Study summary

The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence

Read the detailed description

female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.

Conditions studied

Stress Urinary Incontinence

Browse trials for

Keywords

asymptomatic cystocele.
stress urinary incontinence

Who can participate

Ages eligible: 23 Years to 56 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

female patients
genuine stress incontinence
- asymptomatic cystocele

Exclusion criteria

Exclusion Criteria:

mixed incontinence

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 123 participants (actual)

Study arms

Active comparator
TOT only group
60 patients with stress incontinence and asymptomatic grade 2 cystocele.
Procedure: trans-obturator tape inside-out usingsoft tapes.
Active comparator
concomitant repair group
63 patients with stress incontinence and asymptomatic grade 2 cystocele.
Procedure: trans-obturator tape inside-out usingsoft tapes. · Procedure: anterior colporraphy

Interventions

Proceduretrans-obturator tape inside-out usingsoft tapes.
trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
Also known as: anterior colporrhaphy
Procedureanterior colporraphy

What researchers measure

Primary outcomes

cure rate of stress incontinence
by clinical assessment
Time frame: 3 months after surgery
Denovo urgency
by clinical assessment
Time frame: 3 months after surgery

Secondary outcomes

cure rate of stress incontinence
by clinical assessment
Time frame: 6 months after surgery
cure rate of stress incontinence
by clinical assessment
Time frame: 12 months after surgery
Denovo urgency
by clinical assessment
Time frame: 6 months after surgery
Denovo urgency
by clinical assessment
Time frame: 12 months after surgery

Study locations

1 site

Kasr El Ainiy Hospital
Cairo, 11562, Egypt

Registry details

Key details

Study ID: NCT03296748
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: Sep 28, 2017
Start date: Jun 1, 2016
Primary completion: Sep 2017
Completion: Sep 2017
Last update: Oct 24, 2017

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urinary Incontinence→

Other studies from this sponsor

Kasr El Aini Hospital

Start the discussion