The primary objective of this study is to determine if TVTO-PA is non-inferior to TVT-O in the objective cure of women with Stress Urinary Incontinence (SUI).The secondary objectives of the study are to evaluate changes in incontinence-specific…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Stress Urinary Incontinence
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the objective cure of urinary incontinence at 12
months after surgery.
Objective Success will be defined as:
* A negative SCST without surgical re-intervention for SUI
Patients who are considered to fail based on the above criteria will be asked
to approximate the date of recurrent symptoms in order that a Kaplan-Meier
survival curve of time to failure is developed. Surgical re-intervention will
include surgical repair of SUI, which will include placement of a further
mid-urtheral sling and / or administration of bulking agents.
Secondary outcome
Subjective Success defined by:
* A response of "Very much better" or "Much better" in PGI-I at 12 months
Symptom Change defined as:
* Change from baseline in incontinence-specific symptoms assessed by UDI-6 at
12 months
* Change from baseline in incontinence-specific quality of life assessed by
IIQ-7 at 12 months
* Change from baseline in ICIQ- SF at 12 months
Background summary
Stress urinary incontinence (SUI) is estimated to affect up to a third of adult
women, and the number of women receiving surgical intervention continues to
increase. Although both Tension free Vaginal Tape (TVT) and Tension free
Vaginal Tape (Obturator route) (TVT-O) have high objective cure rates for SUI,
and are associated with low complication rates, mesh related complications such
as mesh exposure, and mesh retraction continue to occur. In an effort to
minimize the amount of mesh placed within the patient in the long-term, a
partially absorbable version of TVT-O (TVTO-PA: Tension free Vaginal Tape
(Obturator route) Partially Absorbable) has been developed.The purpose of this
clinical study is to evaluate the clinical performance of TVTO-PA. The study
will also assess TVT-O PA for non inferiority to TVT-O.
Study objective
The primary objective of this study is to determine if TVTO-PA is non-inferior
to TVT-O in the objective cure of women with Stress Urinary Incontinence (SUI).
The secondary objectives of the study are to evaluate changes in
incontinence-specific symptoms and quality of life following surgery for SUI
using TVTO-PA. Safety will be evaluated.
Study design
This will be a prospective, multi-centre, single-arm study design. The study
will be split into two groups, which will be enrolled sequentially at site
level:
1) Device Run-In (DRI) Group: to ensure that each investigator adopts the
optimal tensioning technique for TVTO-PA;
2) Outcomes Group: to determine the effectiveness of TVTO-PA.
Device Run-In (DRI) Group
Each investigator will be required to complete a minimum of three DRI patients.
Following surgery, each DRI will have a Standardized Cough Stress Test (SCST)
at 1 week (+/- 1day) post procedure to ensure that any learning from the
tensioning of TVTO-PA is obtained prior to performing surgery on the next DRI
case. Each investigator will need to complete 3 DRIs with negative SCST results
prior to enrolling into the Outcomes group. There will be an upper limit of six
on the overall number of DRIs each investigator is allowed to complete; in the
event that an investigator does not achieve the DRI criteria to move to the
Outcomes group, the site will be closed to further enrolment.
The DRI patients will be considered study subjects, and written informed
consent obtained prior to participation in the study. Subjects will be assessed
prior to surgery, during and after the procedure, at 1 week, 6 weeks and 6
months post-procedure. Every DRI patient will be followed up to 6 months for
evaluation of safety and effectiveness. The DRI data will be analyzed
completely separately from the main outcomes study.
At any stage during the DRI group of this study, if deemed appropriate either
by the investigator and/or Ethicon Women*s Health and Urology (EHWU) Medical
Affairs, a Clinical Observer (CO) from Medical Affairs will attend TVTO-PA
procedures. Any key learning experiences observed during the DRI group will be
disseminated to the investigator team.
Outcomes Group
Once each Investigator has successfully completed the DRI group of the study,
they may start enrolment into the Outcomes Group. Enrolment will be
competitive, but each site will be limited to a maximum of 25 patients.
Subjects must give written informed consent prior to any
study related procedures. Subjects will be assessed prior to surgery, during
and after the procedure, at 6 weeks and 6, 12, 24 and 36 months post-procedure.
At baseline, if the patient has already undergone any of the following
investigations within 3 months prior to the study start, and the investigator
considers it is inappropriate to repeat the investigation, the retrospective
data may be used. The use of these retrospective data will also apply to the
DRI subjects (Patient approval for retrospective data use is requested in the
study patient information leaflet and consent):
* POP-Q assessment, performed in accordance with the International Continence
Society method of quantifying pelvic organ prolapse.
* Cough stress test (CST).
Objective success will be measured using a SCST. Patient reported outcomes will
be evaluated using the following questionnaires, which will be completed by the
patients in their local language:
* Urinary Distress Inventory-6 (UDI-6)
* Incontinence Impact Questionnaire-7 (IIQ-7)
* International Consultation on Incontinence Questionnaire-Urinary Incontinence
Short Form (ICIQ-SF)
* Patient Global Impression of Improvement (PGI-I)
* Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire-12
(PISQ-12); for sexually active patients only
Intervention
All patients who meet the inclusion/exclusion criteria in both the device run
in and outcomes group will undergo surgical intervention with TVTO-PA.
Study burden and risks
It can be anticipated that TVTO-PA will have similar risks to the TVT-O device.
Listed below are the complications that have occurred in previous TVT-O studies
and in general use.
Device Adverse Events
* Urinary tract infection
* Urinary frequency or urgency
* Difficulty in passing urine or being unable to pass urine
* Inability to fully empty your bladder
* Thigh/groin pain
* Discomfort/Pain during sex
* Mesh erosion into the vagina
* Mesh erosion into the urethra or bladder
* Wound infection
* Bleeding
* Bladder injury
* Urethral injury
* Fistula formation
* Unintended tissue reaction
* Persistent symptoms of stress urinary incontinence
Potential Procedural Adverse Events
Potential adverse events associated with urogynecological procedures include,
but are not limited to the following:
* Anesthesia reaction (e.g. spinal headache)
* Deep vein thrombosis
* Hematoma
* Life-threatening cardiac or respiratory arrest or other life-threatening event
* Pulmonary embolism possibly leading to death (clot in the lung)
* Upper urinary tract infection
* Adverse events associated with anesthesia
Anticipated Post-Procedural Complications
For any urogynecologic procedure, with or without anesthesia, commonly reported
post-procedure events include the following:
* Fatigue
* Headache
* Nausea and vomiting
* Bleeding
* Febrile morbidity
In some cases these events can be life-threatening. There may be risks
associated with the study device that are currently unknown.
There is a possibility that the Stress Incontinance will not cure and the
patient might experience some or more of the previously mentioned side effects.
The procedure could cure or improve the symptoms of Stress Incontinance
significantly. Cure rates are high with vaginal tape procedures however; there
is no guarantee of a cure. The stress urinary incontinence symptoms may
improve, stay the same, or worsen.
PO Box 1988, Simpson Parkway , Kirkton Campus
LIVINGSTON,EH54 0AB
GB
PO Box 1988, Simpson Parkway , Kirkton Campus
LIVINGSTON,EH54 0AB
GB
Listed location countries
Age
Inclusion criteria
1. Subjects with demonstrable SUI diagnosed by CST, suitable for surgical repair.
2. Age ><=18 years.
3. Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent.
4. Post-void residual volume <100ml as determined prior to the SCST
Exclusion criteria
1. Previous surgical treatment for SUI.
2. Requirement for any concurrent gynecological procedures.
3. Associated pelvic organ prolapse (either symptomatic and/or leading edge >0cm)
4. Exhibits a clinical history of predominantly OAB symptoms.
5. Current anti-cholinergic use.
6. Experimental drug or experimental medical device within 3 months prior to the planned procedure.
7. Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
8. Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
9. History of pelvic radiation.
10. Systemic disease known to affect bladder or bowel function (e.g. Parkinson*s disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
11. Nursing, pregnant or intends future pregnancy.
12. In the investigator*s opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Clinicaltrials.gov number pending |
| CCMO | NL34848.018.10 |