Stress Urinary IncontinencePhase 2/3NCT03295487
ToT and Estrogen in Postmenopausal Females
A Phase 2/3 study testing TVT-O in people with Stress Urinary Incontinence and Postmenopausal Disorder, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 49 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Postmenopausal Disorder
- What is being tested?
- TVT-O
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 30 Nov 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Who cannot join
- presence of urge or mixed incontinence .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.
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.
Read the detailed description
a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female
- Being tested
- TVT-O
- Keywords
- post menopausal stress incontinence, local estrogen
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVT-OProcedure or surgery
Also called local vaginal estrogen cream
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery Receives: Procedure: TVT-O |
| Group B | Active comparator | post menopausal female with genuine stress incontinence treated by TVT-O only Receives: Procedure: TVT-O |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome of the surgery
clinical and urodynamic test improvment of the stress incontinence
Measured: immediately after surgery
outcome of the surgery
clinical and urodynamic test improvment of the stress incontinence
Measured: 3 months after surgery
Secondary outcomes (6)
nocturia ,
symptom and sign from the patients
Measured: immediatly after surgery
frequency,
symptom and sign from the patients
Measured: immediatly after surgery
denovo urgency
symptom and sign from the patients
Measured: immediatly after surgery
denovo urgency
symptom and sign from the patients
Measured: 3 months after surgery
nocturia
symptom and sign from the patients
Measured: 3 months after surgery
frequency
symptom and sign from the patients
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Mar 2017
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295487
- Sponsor's protocol ID
- Saramohamed7880
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2017
- Last updated
- 25 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.
- ClinicalTrials.gov ID
- NCT03295487
- Acronym / sponsor ID
- Saramohamed7880
- Keywords
- post menopausal stress incontinence, local estrogen
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: TVT-Opost menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery |
| Group B | Active comparator | Procedure: TVT-Opost menopausal female with genuine stress incontinence treated by TVT-O only |
Who may qualify
- Ages
- 49 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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
Key exclusion criteria (1 listed)
- presence of urge or mixed incontinence .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TVT-OAlso: local vaginal estrogen creamtransobturator tape has been applied to all the patients in the study,and local estrogen vaginal cream is only applied to patients in group A | Procedure or surgery | Group A, Group B |
Primary outcome
outcome of the surgery
Time frame: immediately after surgery
clinical and urodynamic test improvment of the stress incontinence
outcome of the surgery
Time frame: 3 months after surgery
clinical and urodynamic test improvment of the stress incontinence
6 secondary outcomes
nocturia ,
Time frame: immediatly after surgery
frequency,
Time frame: immediatly after surgery
denovo urgency
Time frame: immediatly after surgery
denovo urgency
Time frame: 3 months after surgery
nocturia
Time frame: 3 months after surgery
frequency
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TVT-O in people with Stress Urinary Incontinence and Postmenopausal Disorder, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome of the surgery (time frame: immediately after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.