Genuine Stress IncontinenceNCT03515109
Prospective Study of Altis System With the TVTO Procedure for the Management of Stress Urinary Incontinence in Women
A study testing Altis tape and TVTO in people with Genuine Stress Incontinence, run by Aretaieio Hospital at 1 site in Greece.
Trial summary
Prospective randomized comparison of minisling (altis) with the TVTO procedure for the management of women with genuine stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 25 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genuine Stress Incontinence
- What is being tested?
- Altis tape and TVTO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 25 Nov 2017to 25 Nov 2018
- Phase
- Interventional
- 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 25 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of previous irradiation in the lower genital tract
- BMI more than 30kg/m2
- previous anti-incontinence surgery, previous vaginal surgery
- having MUCP< 30 cm H2O or Valsava leak point pressure less than than 60 cm H2O
- Mixed urinary incontinence.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Aretaieio University Hospital
Athens, Attica, 11528
PANAGIOTIS VAKAS, 2107473204, P_BAKAS@YAHOO.COM
About this study
Official title: Prospective Randomized Trial of Altis Minisling With the TVTO Transobturator Tape Procedure for the Management of Genuine Stress Urinaty Incontinence in Women
Prospective randomized comparison of minisling (altis) with the TVTO procedure for the management of women with genuine stress urinary incontinence.
Read the detailed description
Prospective randomized study double blinded. Two group of patients consisting group A of 40 patients being operated with altis minisling and group B with 40 patients operated with TVTO procedure. All patients will be operated with epidural anesthesia.
The patients participating in the study will meet the following requirements. a. Having genuine stress urinary incontinence proven by urodynamics, b. be willing to be operated and participate in the study. Exclusion criteria wil be the following: a.History of previous irradiation in the lower genital tract, b. BMI more than 30kg/m2, c.previous anti-incontinence surgery, previous vaginal surgery, e. having MUCP< 20 cm H2O or Valsava leak point pressure less than than 60 cm H2O.
Patients will be allocated in each operation by an automatic system using a computer software.
Primary outcome measure will be the objective cure rate at 6 months as it is assessed with cough stress test during urodynamics. Secondary outcome measures will be the subjective cure rate, improvement and failure rate, the incidence of complications such as obstruction, voiding difficulties, hemorrhage etc. Patients will be asked to complete preoperatively and postoperatively the ICIQ-FLUTS, patient satisfaction questionnaire and the female sexual function index.postoperatively the patients will complete the PGI-I questionnaire.
- Conditions
- Genuine Stress Incontinence
- Being tested
- Altis tape, TVTO
- Keywords
- stress incontinence, female, altis, transobturator tape, minisling
- 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.
Altis tapeProcedure or surgery
placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia
TVTOProcedure or surgery
placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Altis tape surgical placement Receives: Procedure: Altis tape |
| group B | Placebo comparator | TVT transobturator tape placement Receives: Procedure: TVTO |
What is being measured
The primary outcome is the main question the study is designed to answer.
the objective urinary continence rate at 12 months
Primary outcome measure will be the objective urinary continence rate at 12 months as it is assessed with cough stress test during urodynamics.
Measured: 1 year
Secondary outcomes (2)
Subjective urinary continence rate at 12 months follow up
Secondary outcome measure will be the subjective continence rate as it is assessed with the use of the PGI-I questionnaire.
Measured: 1year
Preoperative and postoperative assessment of sexual function
Patients will be asked to complete preoperatively and postoperatively the female sexual function index. Minimum score 2.0 and maximum score 36.0. Higher values represent a better outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start25 Nov 2017
- Primary completion25 Mar 2018
- Study completion25 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genuine Stress 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomised
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieio Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PANAGIOTIS BAKAS MD, Aretaieio Hospital
- Investigators
- PANAGIOTIS VAKAS, Principal investigator, aretaieio university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515109
- Sponsor's protocol ID
- 0001
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2018
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Altis Minisling With the TVTO Transobturator Tape Procedure for the Management of Genuine Stress Urinaty Incontinence in Women
- ClinicalTrials.gov ID
- NCT03515109
- Acronym / sponsor ID
- 0001
- Conditions
- Genuine Stress Incontinence
- Keywords
- stress incontinence, female, altis, transobturator tape, minisling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aretaieio HospitalUniversity, hospital or other
- Study start
- 25 Nov 2017 (actual)
- Primary completion
- 25 Mar 2018 (actual)
- Study completion
- 25 Nov 2018 (estimated)
- First posted
- 3 May 2018 (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.
Prospective randomized comparison of minisling (altis) with the TVTO procedure for the management of women with genuine stress urinary incontinence.
Detailed description
Prospective randomized study double blinded. Two group of patients consisting group A of 40 patients being operated with altis minisling and group B with 40 patients operated with TVTO procedure. All patients will be operated with epidural anesthesia.
The patients participating in the study will meet the following requirements. a. Having genuine stress urinary incontinence proven by urodynamics, b. be willing to be operated and participate in the study. Exclusion criteria wil be the following: a.History of previous irradiation in the lower genital tract, b. BMI more than 30kg/m2, c.previous anti-incontinence surgery, previous vaginal surgery, e. having MUCP< 20 cm H2O or Valsava leak point pressure less than than 60 cm H2O.
Patients will be allocated in each operation by an automatic system using a computer software.
Primary outcome measure will be the objective cure rate at 6 months as it is assessed with cough stress test during urodynamics. Secondary outcome measures will be the subjective cure rate, improvement and failure rate, the incidence of complications such as obstruction, voiding difficulties, hemorrhage etc. Patients will be asked to complete preoperatively and postoperatively the ICIQ-FLUTS, patient satisfaction questionnaire and the female sexual function index.postoperatively the patients will complete the PGI-I questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- prospective randomised
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: Altis tapeAltis tape surgical placement |
| group B | Placebo comparator | Procedure: TVTOTVT transobturator tape placement |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- History of previous irradiation in the lower genital tract
- BMI more than 30kg/m2
- previous anti-incontinence surgery, previous vaginal surgery
- having MUCP< 30 cm H2O or Valsava leak point pressure less than than 60 cm H2O
- Mixed urinary 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 |
|---|---|---|
| Altis tapeplacement of Altis tape through transobturator foramen bilaterally under epidural anesthesia | Procedure or surgery | group A |
| TVTOplacement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia | Procedure or surgery | group B |
Primary outcome
the objective urinary continence rate at 12 months
Time frame: 1 year
Primary outcome measure will be the objective urinary continence rate at 12 months as it is assessed with cough stress test during urodynamics.
2 secondary outcomes
Subjective urinary continence rate at 12 months follow up
Time frame: 1year
Preoperative and postoperative assessment of sexual function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 37888839Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
- Individual participant dataSharing planned: No
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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.
PANAGIOTIS VAKAS principal investigator
aretaieio university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altis tape and TVTO in people with Genuine Stress Incontinence, run by Aretaieio Hospital at 1 site in Greece.
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 0 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 May 2018. 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 Greece. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PANAGIOTIS VAKAS (2107473204, P_BAKAS@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the objective urinary continence rate at 12 months (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515109, which also lists 1 linked publication.
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 3 May 2018.