NCT03295487

Brief Summary

To compare the subjective and objective outcomes of TVT-O procedure alone versus the same procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female with genuine stress incontinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2017

Typical duration for phase_2

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

Study Start

First participant enrolled

March 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

3.8 years

First QC Date

September 20, 2017

Last Update Submit

October 21, 2022

Conditions

Stress Urinary IncontinencePostmenopausal Disorder

Keywords

post menopausal stress incontinencelocal estrogen

Outcome Measures

Primary Outcomes (2)

  • outcome of the surgery

    clinical and urodynamic test improvment of the stress incontinence

    immediately after surgery

  • outcome of the surgery

    clinical and urodynamic test improvment of the stress incontinence

    3 months after surgery

Secondary Outcomes (6)

  • nocturia ,

    immediatly after surgery

  • frequency,

    immediatly after surgery

  • denovo urgency

    immediatly after surgery

  • denovo urgency

    3 months after surgery

  • nocturia

    3 months after surgery

  • +1 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR

post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery

Procedure: TVT-O

Group B

ACTIVE COMPARATOR

post menopausal female with genuine stress incontinence treated by TVT-O only

Procedure: TVT-O

Interventions

TVT-OPROCEDURE

transobturator tape has been applied to all the patients in the study,and local estrogen vaginal cream is only applied to patients in group A

Also known as: local vaginal estrogen cream
Group AGroup B

Eligibility Criteria

Age49 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • menopause patients included in group A should have: no history of breast cancer, ovarian cancer or uterine cancer No history of blood clots or thromboembolism No history of heart disease or stroke No history liver disease. Endometrial thickness less than 5mm Have a normal mammogram

You may not qualify if:

  • presence of urge or mixed incontinence .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

Location

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 28, 2017

Study Start

March 1, 2017

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

EG(1)