Urinary Incontinence, StressPhase 3NCT01148290
Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence
A Phase 3 study testing Tension free vaginal tape and Bulking agent injection in people with Urinary Incontinence, Stress, run by University Magna Graecia at 1 site in Italy.
Trial summary
The surgical treatment of vulvar cancer is characterized by a radical approach as standard, often associated to an important rate of functional complications. This surgery often includes the partial excision of urethra, resulting in a reduction of urethral closure pressure. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Tension free vaginal tape and Bulking agent injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to Apr 2013
- Phase
- Phase 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 18 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stress urinary incontinence by self report, examination and test
- History of radical vulvectomy
Who cannot join
- Systemic disease and/or drugs known to affect bladder function
- Current chemotherapy or radiation therapy
- Detrusor instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Tension-free Vaginal Tape and Bulking Agent for the Treatment of Post-vulvectomy Urinary Incontinence: a Randomized Controlled Trial
The surgical treatment of vulvar cancer is characterized by a radical approach as standard, often associated to an important rate of functional complications. This surgery often includes the partial excision of urethra, resulting in a reduction of urethral closure pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral mobility. As consequence women treated for vulvar cancer may develop urinary incontinence. The incidence of this complication has been differently reported, but seems to reach the 100%. Poor data are available regarding the treatment of post vulvectomy urinary incontinence and no clear indication may be given at regards.
Based on these considerations the aim of this trial will be to compare tension free vaginal tape and bulking agent injection in women with urinary stress incontinence developed after radical surgery for vulvar cancer.
Read the detailed description
Women with urinary stress incontinence developed after radical vulvectomy will be enrolled and randomized in two groups (arm 1 and arm 2). Patients of group 1 will be treated with the tension free vaginal tape, whereas in patients of arm 2 will be used the bulking agent injection.
All eligible patients will undergo baseline assessment consisting of anthropometric, clinical, and urodynamic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Tension free vaginal tape, Bulking agent injection
- Keywords
- bulking agent, emivulvectomy, radical vulvectomy, TVT, urinary incontinence, vulvar cancer
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tension free vaginal tapeProcedure or surgery
Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles
Bulking agent injectionProcedure or surgery
Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)
| Study group | Role | What they receive |
|---|---|---|
| Tension free vaginal tape | Active comparator | Not described Receives: Procedure: Tension free vaginal tape |
| Bulking agent injection | Experimental | Not described Receives: Procedure: Bulking agent injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Measured: 12 months
Secondary outcomes (6)
Intra-operative complication rate
Measured: 1 day
Postoperative complication rate
Measured: 12 months
Recurrence rate
Measured: 12 months
Second surgery for stress urinary incontinence (SUI)
Measured: 12 months
Quality of life
Measured: 12 months
Satisfaction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMay 2009
- Primary completionSep 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Palomba, University Magna Graecia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148290
- Sponsor's protocol ID
- 03/2010
- Status last verified
- Apr 2013
- First submitted
- 21 Jun 2010
- Last updated
- 8 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Tension-free Vaginal Tape and Bulking Agent for the Treatment of Post-vulvectomy Urinary Incontinence: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01148290
- Acronym / sponsor ID
- 03/2010
- Conditions
- Urinary Incontinence, Stress
- Keywords
- bulking agent, emivulvectomy, radical vulvectomy, TVT, urinary incontinence, vulvar cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Jun 2010 (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.
The surgical treatment of vulvar cancer is characterized by a radical approach as standard, often associated to an important rate of functional complications. This surgery often includes the partial excision of urethra, resulting in a reduction of urethral closure pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral mobility. As consequence women treated for vulvar cancer may develop urinary incontinence. The incidence of this complication has been differently reported, but seems to reach the 100%. Poor data are available regarding the treatment of post vulvectomy urinary incontinence and no clear indication may be given at regards.
Based on these considerations the aim of this trial will be to compare tension free vaginal tape and bulking agent injection in women with urinary stress incontinence developed after radical surgery for vulvar cancer.
Detailed description
Women with urinary stress incontinence developed after radical vulvectomy will be enrolled and randomized in two groups (arm 1 and arm 2). Patients of group 1 will be treated with the tension free vaginal tape, whereas in patients of arm 2 will be used the bulking agent injection.
All eligible patients will undergo baseline assessment consisting of anthropometric, clinical, and urodynamic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tension free vaginal tape | Active comparator | Procedure: Tension free vaginal tape |
| Bulking agent injection | Experimental | Procedure: Bulking agent injection |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stress urinary incontinence by self report, examination and test
- History of radical vulvectomy
Key exclusion criteria (3 listed)
- Systemic disease and/or drugs known to affect bladder function
- Current chemotherapy or radiation therapy
- Detrusor instability
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 |
|---|---|---|
| Tension free vaginal tapeSmall incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles | Procedure or surgery | Tension free vaginal tape |
| Bulking agent injectionThree Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA) | Procedure or surgery | Bulking agent injection |
Primary outcome
Cure rate
Time frame: 12 months
6 secondary outcomes
Intra-operative complication rate
Time frame: 1 day
Postoperative complication rate
Time frame: 12 months
Recurrence rate
Time frame: 12 months
Second surgery for stress urinary incontinence (SUI)
Time frame: 12 months
Quality of life
Time frame: 12 months
Satisfaction
Time frame: 12 months
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 8 Apr 2013.
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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 3 study testing Tension free vaginal tape and Bulking agent injection in people with Urinary Incontinence, Stress, run by University Magna Graecia at 1 site in Italy.
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 2 inclusion and 3 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 8 Apr 2013. 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 Italy. 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 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?
Cure rate (time frame: 12 months). 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 8 Apr 2013.