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Improving sexual function in patients with vulvar lesions


- candidate number27485
- NTR NumberNTR6555
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jul-2017
- Secondary IDsP17ISF 
- Public TitleImproving sexual function in patients with vulvar lesions
- Scientific TitleImproving sexual function and well-being in patients with (pre) invasive vulvar lesions; a controlled pilot study.
- ACRONYM
- hypothesisThe aim of this study is to evaluate whether consulting a sexologist will have better outcomes considering quality of life and sexual function in women who underwent surgical treatment for (pre)malignant vulvar lesions.
- Healt Condition(s) or Problem(s) studiedSexual function, Vulvar lesion
- Inclusion criteria--Age 18 years or older
− Women with HSIL, dVIN or carcinoma of the vulva
− Women who are sexually active prior to the onset of the disease and desire to be sexual active after surgery
− Women who will undergo surgery or laser vaporisation of the vulva for the first time
− Signed and written informed consent
- Exclusion criteria− Women with pre-existing sexual dysfunction
− Women with advanced disease (FIGO stage IV)
− Women who need adjuvant radiotherapy (of which we know of on forehand)
− Women with a recurrent vulvar disease
− Women who are unable to understand the Dutch language
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 31-jul-2017
- planned closingdate31-jul-2018
- Target number of participants20
- InterventionsQuality of live questionaires and two consults with sexologist for half the group.
- Primary outcomeQuality of life and sexual function
- Secondary outcomenot applicable
- TimepointsQoL questionaires before surgery, 4 months after surgery and 6 months after surgery. consult with sexologist before and after surgery.
- Trial web site
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIES Jesse van Altena
- CONTACT for SCIENTIFIC QUERIES Henry Zijlmans
- Sponsor/Initiator NKI-AVL
- Funding
(Source(s) of Monetary or Material Support)
NKI-AVL
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD3-jul-2017 - 29-jul-2017


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