Validation of the DIVA (Day to Day Impact of Vaginal Aging) Questionnaire for Portuguese Women

NCT07250490 | Completed

• 1 other identifier: 6047/2022 CES ARS-LVT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the reliability and validity of the Portuguese version of the DIVA questionnaire in Portuguese women. This validation will support its use both in research and in routine clinical practice in this population.

Conditions

Vulvovaginal Atrophy; Genital Disorder; PROMs

Keywords

Genitourinary syndrome of menopause (GSM); Female Genital Atrophy; Female Sexual Dysfunction (FSD); Dyspareunia; Female Genital Disorder; Vaginal dryness; Vaginal Itching

Outcome Measures

Primary Outcomes (1)

• Psychometric validation of Day to Day Impact of Vaginal Ageing Questionnaire (DIVA) to Portuguese Woman from Portugal Country. The methodological approach is a descriptive cross-sectional study of qualitative and quantitative variables.

  Primary outcome measure focuses on the psychometric validation of the portuguese version of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire, including the evaluation of its internal consistency, factorial structure, construct validity, and test-retest reliability. The DIVA assesses the impact of vaginal aging symptoms in the daily activities, sexual function, emotional well-being, and self-concept/body image domains, with scores ranging from 0 to 92 (higher scores = worse impact). Two versions of the questionnaire are available: the full version with 23 items, which includes four items within the sexual function construct that can only be answered by women who are sexually active; and a shorter version with 19 items, which can be applied regardless of sexual activity status. Each item is rated on a five-point Likert scale, and the score for each dimension is calculated as the Mean of the corresponding items.

  Each patient complete the five questionnaires at baseline and a subset of 50 patients were selected to repeat the DIVA questionnaire and the Symptoms questionnaire 2 to 30 days after baseline to access Test-retest reliability.

Secondary Outcomes (1)

• Psychometric validation of Day to Day Impact of Vaginal Aging Questionnaire to Portuguese Woman with confirmatory factor analyses with other constructs

  Each patient complete the five questionnaires at baseline and a subset of 50 patients were selected to repeat the DIVA questionnaire and the Symptoms questionnaire 2 to 30 days after baseline to access Test-retest reliability.

Study Arms (1)

Adult women attending a clinical appointment

Adult women attending medical appointments. For the convenience normative sample of the general population will include users of a health center large urban healthcare; the Personalized Health Care Unit (UCSP) of Sete Rios, in Lisbon. For the convenience clinical sample, users of the general gynecology consultation at a private hospital (Hospital Dom Manuel de Aguiar) and the gynecology consultation at a public hospital (Hospital Santo André), units located in an urban center in Leiria. Those from a private clinic in the north of the country, in Braga, will also be included. It is intended to include a minimum of 230 questionnaires, according to the recommendation of the COSMIN13, to allow an assessment of invariance correlation

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: Women attending a medical consultation will be eligible for inclusion.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women attending a medical consultation will be eligible for inclusion. The normative convenience sample from the general population will be recruited from the south of Portugal, from a large urban primary care center, the Sete Rios Personalized Health Care Unit (UCSP), in Lisbon. The clinical convenience sample will be recruited from the general gynecology outpatient clinic of a private hospital (Hospital Dom Manuel de Aguiar) and from the urogynecology outpatient clinic of a public hospital (Hospital Santo André), both located in an urban center in Leiria. Also from the north of country recruitment will take place at a private clinical in Braga city.

You may qualify if:

• dryness
• itching
• irritation
• discomfort on urination or during intercourse
• pain on urination or during intercourse
• bleeding during intercourse

You may not qualify if:

• pregnancy
• active cancer
• inability to speak Portuguese
• mental or physical condition that prevents providing coherent responses to the questionnaire.

Sponsors & Collaborators

• Instituto Politécnico de Leiria: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Hospital Santo André - Centro Hospitalar de Leiria: collaborator
• University of Minho: collaborator

Study Sites (1)

Personalized Health Care Unit of Sete Rios

Lisbon, Lisbon District, 2410-083, Portugal

Location

Related Publications (14)

• Santos Pechorro P, Monteiro Pascoal P, Monteiro Pereira N, Poiares C, Neves Jesus S, Xavier Vieira R. Validação da versão portuguesa do Índice de Funcionamento Sexual Feminino - 6. Published online 2016. doi:10.1016/j.androl.2016.06.001

  BACKGROUND

• Ferreira PL, Ferreira LN, Pereira LN. [Contribution for the validation of the Portuguese version of EQ-5D]. Acta Med Port. 2013 Nov-Dec;26(6):664-75. Epub 2013 Dec 20. Portuguese.

  PMID: 24388252 BACKGROUND

• Mokkink Cecilia AC Prinsen Donald L Patrick Jordi Alonso Lex M Bouter LB, Mokkink CL. COSMIN Study Design checklist for Patient-reported outcome measurement instruments. Accessed May 15, 2022. www.cosmin.nl

  BACKGROUND

• Sert B, Ozgul S. Turkish day-to-day impact of vaginal aging questionnaire: reliability, validity and relationship with pelvic floor distress. Int Urogynecol J. 2022 Nov;33(11):3093-3102. doi: 10.1007/s00192-022-05085-w. Epub 2022 Jan 27.

  PMID: 35084513 BACKGROUND

• Gabes M, Stute P, Apfelbacher C. Validation of the German Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire in Peri- and Postmenopausal Women. Sex Med. 2021 Aug;9(4):100382. doi: 10.1016/j.esxm.2021.100382. Epub 2021 Jun 12.

  PMID: 34130226 BACKGROUND

• Moral E, Delgado JL, Carmona F, Caballero B, Guillan C, Gonzalez PM, Suarez-Almarza J, Velasco-Ortega S, Nieto Magro C; writing group of GENISSE study. The impact of genitourinary syndrome of menopause on well-being, functioning, and quality of life in postmenopausal women. Menopause. 2018 Dec;25(12):1418-1423. doi: 10.1097/GME.0000000000001148.

  PMID: 29944636 BACKGROUND

• Hunter MM, Guthrie KA, Larson JC, Reed SD, Mitchell CM, Diem SJ, LaCroix AZ, Huang AJ. Convergent-Divergent Validity and Correlates of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health Trial. J Sex Med. 2020 Jan;17(1):117-125. doi: 10.1016/j.jsxm.2019.10.010. Epub 2019 Dec 4.

  PMID: 31812686 BACKGROUND

• Gabes M, Knuttel H, Stute P, Apfelbacher CJ. Measurement properties of patient-reported outcome measures (PROMs) for women with genitourinary syndrome of menopause: a systematic review. Menopause. 2019 Nov;26(11):1342-1353. doi: 10.1097/GME.0000000000001390.

  PMID: 31688581 BACKGROUND

• Huang AJ, Gregorich SE, Kuppermann M, Nakagawa S, Van Den Eeden SK, Brown JS, Richter HE, Walter LC, Thom D, Stewart AL. Day-to-Day Impact of Vaginal Aging questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. Menopause. 2015 Feb;22(2):144-54. doi: 10.1097/GME.0000000000000281.

  PMID: 24983271 BACKGROUND

• Nappi RE, Palacios S, Panay N, Particco M, Krychman ML. Vulvar and vaginal atrophy in four European countries: evidence from the European REVIVE Survey. Climacteric. 2016 Apr;19(2):188-97. doi: 10.3109/13697137.2015.1107039. Epub 2015 Nov 19.

  PMID: 26581580 BACKGROUND

• Nappi RE, Palacios S, Bruyniks N, Particco M, Panay N; EVES Study investigators. The burden of vulvovaginal atrophy on women's daily living: implications on quality of life from a face-to-face real-life survey. Menopause. 2019 May;26(5):485-491. doi: 10.1097/GME.0000000000001260.

  PMID: 30422932 BACKGROUND

• Eremenco S, Pease S, Mann S, Berry P; PRO Consortium's Process Subcommittee. Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices. J Patient Rep Outcomes. 2017;2(1):12. doi: 10.1186/s41687-018-0037-6. Epub 2018 Feb 27.

  PMID: 29757299 BACKGROUND

• Calvert M, King M, Mercieca-Bebber R, Aiyegbusi O, Kyte D, Slade A, Chan AW, Basch E, Bell J, Bennett A, Bhatnagar V, Blazeby J, Bottomley A, Brown J, Brundage M, Campbell L, Cappelleri JC, Draper H, Dueck AC, Ells C, Frank L, Golub RM, Griebsch I, Haywood K, Hunn A, King-Kallimanis B, Martin L, Mitchell S, Morel T, Nelson L, Norquist J, O'Connor D, Palmer M, Patrick D, Price G, Regnault A, Retzer A, Revicki D, Scott J, Stephens R, Turner G, Valakas A, Velikova G, von Hildebrand M, Walker A, Wenzel L. SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ Open. 2021 Jun 30;11(6):e045105. doi: 10.1136/bmjopen-2020-045105.

  PMID: 34193486 BACKGROUND

• Mattos S, Moreira T, Pereira D, et al. INSTRUMENTS FOR MEASURING SELF-PERCEPTED HEALTH AMONG ADULTS: A SCOPING REVIEW. Psicol Saúde Doença. 2020;21(03):878- 895. doi:10.15309/20PSD210328

  BACKGROUND

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Andreia A Antunes, PhD Student

  Minho University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: affiliated investigator, PhD Student, Consultant of Gynecology and Obstetrics

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 26, 2025
• Study Start: October 2, 2022
• Primary Completion: January 22, 2024
• Study Completion: September 4, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)