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1-year results after MiniArc.


- candidate number11302
- NTR NumberNTR3338
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2012
- Secondary IDsNL 36271.018.11 CCMO
- Public Title1-year results after MiniArc.
- Scientific TitleThe MiniArc single incision sling for female stress urinary incontinence: clinical results of a prospective evaluation with a minimal follow up of one year.
- ACRONYM
- hypothesisThe aim of this study is to evaluate the succesrate of the MiniArc.
- Healt Condition(s) or Problem(s) studiedMiniArc, Stress urinary incontinence, Single incision sling
- Inclusion criteriaAll patients (informed consent) who underwent MiniArc procedure as a treatment of stress urinary incontinence from March 2008 till January 2011 in the Flevohospital, Almere.
- Exclusion criteriaNot willing to participate, severe other disease in uro-gynaecological area.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 5-mrt-2012
- planned closingdate30-apr-2012
- Target number of participants95
- InterventionsN/A
- Primary outcomePercentage females without stress urinary incontinence.
- Secondary outcomePercentage females with urge urinary incontinence after surgery.
- TimepointsAll patients were asked to fill in a urinary chart (bijlage) for two days, listing the frequency and amount of intake and peeing. They were also asked to state if, when and how severe they suffer from urinary (stress) incontinence. Patients were familiar with the procedure.

Patients were seen by two doctors (LLN, FvM) familiar with the complaints and symptoms of incontinence. All patients underwent a PAD test and a coughing stress test.
For the PAD test patients were asked to walk, talk, laugh, cough etc for one hour wearing a provided pad without going to the toilet to pee. After one hour the PAD was weighted. With a full bladder patients were asked to take place in the gynaecological chair. With a bladders scan the volume was measured. Patients were then asked to cough 3 times and blow on their hand to see if urine leaking could be objected/observed.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.L. Nieuwenhuis
- CONTACT for SCIENTIFIC QUERIES L.L. Nieuwenhuis
- Sponsor/Initiator Flevo Hospital
- Funding
(Source(s) of Monetary or Material Support)
Flevo Hospital
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD9-mrt-2012 - 17-mrt-2012


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