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Lichen Sclerosus - the Influence on Quality of Life

Primary Purpose

Lichen Sclerosus

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Standard care and sexological counseling
Sponsored by
Vendsyssel Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Sclerosus focused on measuring Treatment, Quality of Life, Sexology, Women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with Lichen Sclerosus
  • Age over 18 years

Exclusion Criteria:

  • Patients who does not understand or speak Danish
  • Patients with a psychiatric diagnosis and can not follow the course

Sites / Locations

  • Vendsyssel Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard care and sexological counseling

Standard care

Arm Description

Standard care including gynecological examination and 6-8 sexological consultations.

Standard care including gynecological examination.

Outcomes

Primary Outcome Measures

Quality of Life in women with Lichen Sclerosus
Change in EuroQol five dimension (EQ-5D) score. The descriptive system comprises 5 dimensions (mobili-ty, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2018
Last Updated
May 22, 2020
Sponsor
Vendsyssel Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03419377
Brief Title
Lichen Sclerosus - the Influence on Quality of Life
Official Title
Lichen Sclerosus - the Influence on Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
May 22, 2020 (Actual)
Study Completion Date
May 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vendsyssel Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.
Detailed Description
The patients are randomized to an intervention Group and a control Group. The intervention gets 6-8 visits with clinical sexologist and the control Group is having the usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Sclerosus
Keywords
Treatment, Quality of Life, Sexology, Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care and sexological counseling
Arm Type
Experimental
Arm Description
Standard care including gynecological examination and 6-8 sexological consultations.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care including gynecological examination.
Intervention Type
Other
Intervention Name(s)
Standard care and sexological counseling
Intervention Description
6-8 sexological consultants in a period of six months
Primary Outcome Measure Information:
Title
Quality of Life in women with Lichen Sclerosus
Description
Change in EuroQol five dimension (EQ-5D) score. The descriptive system comprises 5 dimensions (mobili-ty, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.
Time Frame
Six months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with Lichen Sclerosus Age over 18 years Exclusion Criteria: Patients who does not understand or speak Danish Patients with a psychiatric diagnosis and can not follow the course
Facility Information:
Facility Name
Vendsyssel Hospital
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
35333024
Citation
Vittrup G, Westmark S, Riis J, Morup L, Heilesen T, Jensen D, Melgaard D. The Impact of Psychosexual Counseling in Women With Lichen Sclerosus: A Randomized Controlled Trial. J Low Genit Tract Dis. 2022 Jul 1;26(3):258-264. doi: 10.1097/LGT.0000000000000669. Epub 2022 Mar 25.
Results Reference
derived

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Lichen Sclerosus - the Influence on Quality of Life

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