Stress Urinary IncontinencePhase 3NCT00475839
Study Comparing Tension-free Vaginal Tape With the Monarc Procedure for Stress Urinary Incontinence
A Phase 3 study testing Tension-free Vaginal Tape and Monarc sub-fascial hammock in people with Stress Urinary Incontinence, run by The Cleveland Clinic at 3 sites in United States.
Trial summary
Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Tension-free Vaginal Tape and Monarc sub-fascial hammock
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2004to Jul 2007
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urinary incontinence symptoms
- Urodynamic stress incontinence confirmed with multichannel urodynamic testing
- Age of at least 21 years
- Desires surgical correction of stress urinary incontinence
Who cannot join
- Post-void residual volume >100cc
- Detrusor overactivity on preoperative multichannel urodynamic testing
- History of previous synthetic, biologic or fascial sub-urethral sling
- Desires future childbearing
- Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurativa
- History of bleeding diathesis or current anti-coagulation therapy
Show all 10Show fewer
- Inguinal lymphadenopathy or inguinal/vulvar mass
- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence (i.e. drug effect)
- Contraindication to surgery
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Good Samaritan Hospital
Cincinnati, Ohio, 45520
Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: A Randomized Trial Comparing the Monarc Subfascial Hammock Procedure With Tension-free Vaginal Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence
Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Many different surgical procedures have been described for the treatment of SUI and there is no general agreement as to the most effective. This study compares the safety and efficacy of the tension-free vaginal tape procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Tension-free Vaginal Tape, Monarc sub-fascial hammock
- Keywords
- stress urinary incontinence, sling procedures, tension-free vaginal tape, transobturator
- 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.
Tension-free Vaginal TapeDevice
Monarc sub-fascial hammockDevice
| Study group | Role | What they receive |
|---|---|---|
| Tension-free Vaginal Tape | Active comparator | Not described Receives: Device: Tension-free Vaginal Tape |
| Monarc Sub-fascial hammock | Active comparator | Not described Receives: Device: Monarc sub-fascial hammock |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention
Measured: 12 months
Secondary outcomes (6)
Complications
Postoperative pain
Measured: 2 weeks, 6 weeks
HRQOL
Measured: 6 months, 12 months, 18 months, 24 months
Sexual function
Measured: 12 months, 24 months
Global improvement in bladder function
Measured: 6 months, 12 months, 18 months, 24 months
Development of anterior vaginal prolapse
Measured: 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startDec 2004
- Study completionJul 2007
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 Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Single blind
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Good Samaritan Hospital, Ohio, Greater Baltimore Medical Center, American Medical Systems
- Investigators
- Matthew D Barber, MD, MHS, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475839
- Sponsor's protocol ID
- CCF 7616
- Status last verified
- Jan 2013
- First submitted
- 17 May 2007
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e.
PubMed 18310363
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Monarc Subfascial Hammock Procedure With Tension-free Vaginal Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00475839
- Acronym / sponsor ID
- CCF 7616
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, sling procedures, tension-free vaginal tape, transobturator
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Good Samaritan Hospital, Ohio, Greater Baltimore Medical Center, American Medical Systems
- Study start
- Dec 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 21 May 2007 (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.
Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Many different surgical procedures have been described for the treatment of SUI and there is no general agreement as to the most effective. This study compares the safety and efficacy of the tension-free vaginal tape procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tension-free Vaginal Tape | Active comparator | Device: Tension-free Vaginal Tape |
| Monarc Sub-fascial hammock | Active comparator | Device: Monarc sub-fascial hammock |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Urinary incontinence symptoms
- Urodynamic stress incontinence confirmed with multichannel urodynamic testing
- Age of at least 21 years
- Desires surgical correction of stress urinary incontinence
Key exclusion criteria (10 listed)
- Post-void residual volume >100cc
- Detrusor overactivity on preoperative multichannel urodynamic testing
- History of previous synthetic, biologic or fascial sub-urethral sling
- Desires future childbearing
- Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurativa
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 Tape | Device | Tension-free Vaginal Tape |
| Monarc sub-fascial hammock | Device | Monarc Sub-fascial hammock |
Primary outcome
The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention
Time frame: 12 months
6 secondary outcomes
Complications
Postoperative pain
Time frame: 2 weeks, 6 weeks
HRQOL
Time frame: 6 months, 12 months, 18 months, 24 months
Sexual function
Time frame: 12 months, 24 months
Global improvement in bladder function
Time frame: 6 months, 12 months, 18 months, 24 months
Development of anterior vaginal prolapse
Time frame: 12 months, 24 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 10 Jan 2013.
- Derived from this study: PubMed 18310363Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e.
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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.
Matthew D Barber, MD, MHS principal investigator
The Cleveland Clinic
3 sites 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 Monarc sub-fascial hammock in people with Stress Urinary Incontinence, run by The Cleveland Clinic at 3 sites in United States.
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 4 inclusion and 10 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 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention (time frame: 12 months). 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 NCT00475839, 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 10 Jan 2013.