Urinary IncontinencePhase 4NCT00782990
A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence
A Phase 4 study testing Surgical treatment: TVT and Surgical treatment: colposuspension in people with Urinary Incontinence, run by Hospital Severo Ochoa at 1 site in Spain.
Trial summary
Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress incontinence (SUI). Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Surgical treatment: TVT and Surgical treatment: colposuspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2001to Jun 2007
- Phase
- Phase 4
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 35 and 70 who had completed their family with a clinical (Booney test positive) and urodynamic diagnosis of Stress Urinary Incontinence
- Previous surgery for prolapse, incontinence or bladder disease, urodynamic diagnosis of detrusor overactivity, or voiding difficulty (defined as maximum flow less than 15 ml/second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 ml)
- Cystocele over grade I
- Previous hysterectomy
- Body mass index (BMI) of 40 or more
- Uncontrolled diabetes
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- Neurological disease
- Recurrent urinary tract infections
- Genital atrophy precluding vaginal surgery
- Known bleeding diathesis or current anticoagulant therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence
Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress incontinence (SUI).
Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.
Intervention: 24 patients randomised to TVT and 25 to CS.
Read the detailed description
Background: Evidence comparing effectiveness of tension-free vaginal tape (TVT) and Burch's colposuspension (CS) in the long term follow-up is weak.
Objective: To compare TVT with CS as primary treatment for stress incontinence (SUI).
Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.
Intervention: 24 patients randomised to TVT and 25 to CS. Measurements: Main outcome: Assessment before treatment and at 6-months, 1-year and 3-years postoperatively with the incontinence severity symptoms index (ISS) and the incontinence impact symptoms index (IIS) Secondary outcome: 3 groups to asses cure rates: cured, improved and failure.
- Conditions
- Urinary Incontinence
- Being tested
- Surgical treatment: TVT, Surgical treatment: colposuspension
- Keywords
- stress urinary incontinence, female incontinence, surgical treatment, Female stress urinary incontinence
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment: TVTProcedure or surgery
Surgical treatment: colposuspensionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| tvt group | Active comparator | Surgical treatment for incontinence: TVT Receives: Procedure: Surgical treatment: TVT |
| Burch group | Active comparator | Surgical treatment for incontinence: Colposuspension Receives: Procedure: Surgical treatment: colposuspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)
Secondary outcomes (1)
Criteria were established to include patients in one of three groups: cure, improved and treatment failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJan 2001
- Primary completionOct 2004
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Severo Ochoa
- Sponsor type
- University, hospital or other
- Investigators
- Téllez M Martínez-Fornés, urologist, Principal investigator, Urology department. Hospital severo Ochoa.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782990
- Sponsor's protocol ID
- TVTvsBURCH_2001_HSVO
- Status last verified
- Nov 2008
- First submitted
- 30 Oct 2008
- Last updated
- 5 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence
- ClinicalTrials.gov ID
- NCT00782990
- Acronym / sponsor ID
- TVTvsBURCH_2001_HSVO
- Conditions
- Urinary Incontinence
- Keywords
- stress urinary incontinence, female incontinence, surgical treatment, Female stress urinary incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Severo OchoaUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Oct 2004 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 31 Oct 2008 (estimated)
- 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.
Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress incontinence (SUI).
Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.
Intervention: 24 patients randomised to TVT and 25 to CS.
Detailed description
Background: Evidence comparing effectiveness of tension-free vaginal tape (TVT) and Burch's colposuspension (CS) in the long term follow-up is weak.
Objective: To compare TVT with CS as primary treatment for stress incontinence (SUI).
Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.
Intervention: 24 patients randomised to TVT and 25 to CS. Measurements: Main outcome: Assessment before treatment and at 6-months, 1-year and 3-years postoperatively with the incontinence severity symptoms index (ISS) and the incontinence impact symptoms index (IIS) Secondary outcome: 3 groups to asses cure rates: cured, improved and failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tvt group | Active comparator | Procedure: Surgical treatment: TVTSurgical treatment for incontinence: TVT |
| Burch group | Active comparator | Procedure: Surgical treatment: colposuspensionSurgical treatment for incontinence: Colposuspension |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women between the ages of 35 and 70 who had completed their family with a clinical (Booney test positive) and urodynamic diagnosis of Stress Urinary Incontinence
- Previous surgery for prolapse, incontinence or bladder disease, urodynamic diagnosis of detrusor overactivity, or voiding difficulty (defined as maximum flow less than 15 ml/second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 ml)
- Cystocele over grade I
- Previous hysterectomy
- Body mass index (BMI) of 40 or more
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Surgical treatment: TVT | Procedure or surgery | tvt group |
| Surgical treatment: colposuspension | Procedure or surgery | Burch group |
Primary outcome
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)
1 secondary outcome
Criteria were established to include patients in one of three groups: cure, improved and treatment failure
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 5 Nov 2008.
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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.
Téllez M Martínez-Fornés, urologist principal investigator
Urology department. Hospital severo Ochoa.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical treatment: TVT and Surgical treatment: colposuspension in people with Urinary Incontinence, run by Hospital Severo Ochoa at 1 site in Spain.
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 10 inclusion and 0 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 5 Nov 2008. 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 Spain. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS). 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 5 Nov 2008.