Primary goal:The cure at 12 monthsSecondary goals:1. Cough Stress Test (HST): objective endpoint2. Question 3 of the UDI-6 questionnaire: subjective endpoint3. Primary endpoint at 6 weeks, 6 months, and 36 months 24maanden4. Reduction of urine loss…
ID
Source
Brief title
Condition
- Urethral disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the proportion of subjects that meet the criteria of
cure at 12 months.
Healing is defined as negative cough stress test (HST) and NO to question 3 of
the UDI-6 questionnaire: Do you often suffer from urine leakage related to
coughing sneezing or laughing.
It is a composite endpoint of objective and subjective outcome measures.
Secondary outcome
Secondary goals:
1. Cough Stress Test (HST): objective endpoint
2. Question 3 of the UDI-6 questionnaire: subjective endpoint
3. Primary endpoint at 6 weeks, 6 months, and 36 months 24maanden
4. Reduction of urine loss in 24 hours at 6 weeks and 12 months.
5. Postoperative improvement adhv PGI-I questionnaire and patient
satisfaction at every visit
6. Qmax and PVR at 6 weeks and 12 months and the variation compared to
Baseline
7. anesthesia type
8. operation time
9. duration of hospitalization
10. Postoperative pain score using VAS 0-10
11. Device and procedure related adverse events
Background summary
The surgical treatment of women with stress incontinence is the mid-urethral
sling the gold standard.
There are several ways to place the sling.
The first technique is the retropubic approach (TVT ®) with this technique is a
complication bladder perforation.
The second approach is the transobturator route (TVT-O ®) here is hardly any
risk of bladder perforation causing Horticultural but this technique has a
higher risk of groin pain in the compare operation with the TVT ®. Pain in the
groin is probably caused by the tape through the muscles of the pelvis and
thigh is placed.
The new device Altis ® Single incision sling is in the same direction as the
TVT-O ® posted to the risk of bladder perforation to minimize unlike the TVT-O
® is the tape just through the foramen obturatorium placed waabij it using a
anchor behind the foramen fixes. A possible advantage is that the needle is not
covered by the muscles to the outside have to be carried out. It is expected
that the Altis ® SIS will give less pain than the TVT-O ®
Study objective
Primary goal:
The cure at 12 months
Secondary goals:
1. Cough Stress Test (HST): objective endpoint
2. Question 3 of the UDI-6 questionnaire: subjective endpoint
3. Primary endpoint at 6 weeks, 6 months, and 36 months 24maanden
4. Reduction of urine loss in 24 hours at 6 weeks and 12 months.
5. Postoperative improvement adhv PGI-I questionnaire and patient
satisfaction at every visit
6. Qmax and PVR at 6 weeks and 12 months and the variation compared to
Baseline
7. anesthesia type
8. operation time
9. duration of hospitalization
10. Postoperative pain score using VAS 0-10
11. Device and procedure related adverse events
Study design
Multi center single arm prospective postmarket study
Intervention
Surgical procedure involving a single incision in witch a mid urethral sling
will be placed
Study burden and risks
The tax which the research entails consists of completing the questionnaires, 3
extra visits in the context of the study at 12 months 24 months and 36 months.
There is no other risk than the known risks related to the surgical treatment
of stress incontinence
The Altis ® Singele Incision System is already available for use in the clinic
Dr. van Heesweg 2
Zwolle 8025 AB
NL
Dr. van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
1.Pre dominant stress urinary incontinence
2.The stress urinary incontinence is confirmed during physical examination, stresstest or urodynamic assessment
Exclusion criteria
1. Hisstory of anti incontinence surgery
2. A post voiding bladder volume more than 100ml
3. Co-morbidity
4. Desire for future pregnancy
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 |
|---|---|
| CCMO | NL42900.075.13 |