Clinical trial NCT04701047: Prospective Observational Prolapse Study
Official title: Prospective Observational Study with Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary Vs. Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaginal Prolapse
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The research population will include women above the age of 18 years old who consult the department of urology or the department of gynaecology at the university hospital of Ghent with symptoms of vaginal prolapse. The patients will be recruited by their attending physician. There will be no exclusion on the degree of vaginal prolapse. All symptomatic prolapses will be included in this study. Exclusion criteria will be having undergone a previous treatment with a pessary or surgery for vaginal prolapse, contraindications for surgery or pessary use, active of passive child wish, not able to understand the Dutch language and not able to give a written consent.

Brief summary: The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.

Detailed description: The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.

The questionnaires that will be used are the PFDI-20 (pelvic floor distress inventory), PFIQ-7 (pelvic floor impact questionnaire), PISQ-9 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) and a custom-made questionnaire to further investigate the behavior towards pessary use of our patients and the adverse effects they are dealing with. The questionnaires will be taken before the treatment has started, 6 weeks post treatment start, one-year post treatment start, two years post treatment start and 5 years post treatment start. A POP-Q (Pelvic Organ Prolapse Quantification) investigation will be performed to estimate the degree of vaginal prolapse before the start of the treatment. Since clinical follow up is not necessarily needed after one year for the women who undergo surgery, their questionnaires will be taken via telephone or e-mail. For women that are being treated with pessaries the investigators will also take our custom-made questionnaire at 4 and 8 months after starting the treatment.

The investigators would like to recruit 100 women for this study, older than 18 years old who have not undergone a previous treatment with a pessary or surgery for vaginal prolapse. Another exclusion criterium are women who still have a child wish and women who have contraindications for surgery. The investigators will also exclude women who don't speak Dutch or women who cannot give a written consent.

The investigators hypothesize that woman being treated with one year of pessary use are overall not having more symptoms than woman that underwent a surgery. The investigators hypothesize that woman being treated with five years of pessary use are overall having less symptoms than woman that underwent a surgery.

Eligibility criteria: Inclusion Criteria:

* women with a symptomatic vaginal prolapse
* older than 18 years

Exclusion Criteria:

* under 18 years old
* undergone a previous treatment with a pessary or surgery for vaginal prolapse
* contra-indications for surgery or pessary use
* active or passive child wish
* not able to understand the Dutch language
* not able to give a written consent

Primary outcomes:
measure: Change in Pelvic Floor Disability Index (PFDI-20)
timeFrame: Baseline, 6 weeks, one year, two years, five years
measure: Change in pelvic floor impact questionnaire (PFIQ-7)
timeFrame: Baseline, 6 weeks, one year, two years, five years
measure: Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
timeFrame: Baseline, 6 weeks, one year, two years, five years
Secondary outcomes:
measure: Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire
timeFrame: 4 months after start of therapy
measure: Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire
timeFrame: 8 months after start of therapy
measure: Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire
timeFrame: 4 months after initiation of therapy
measure: Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire
timeFrame: 8 months after initiation of therapy
measure: Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire
timeFrame: 4 months after initiation of therapy
measure: Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire
timeFrame: 8 months after initiation of therapy
Other outcomes:
measure: Amount of pessaries tried before current pessary
timeFrame: 4 months after initiation of therapy
measure: Amount of pessaries tried before current pessary
timeFrame: 8 months after initiation of therapy
measure: Duration of the pessary consultation
timeFrame: 4 months after initiation of therapy
measure: Duration of the pessary consultation
timeFrame: 8 months after initiation of therapy
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: UZ Gent
name: Tjalina Hamerlynck
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Gent
name: Steven Weyers
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Gent
name: Van Wessel Steffi
role: STUDY_DIRECTOR
affiliation: UZ Gent
name: Abosi Appeadu Kessewa
role: STUDY_CHAIR
affiliation: UZ Gent
name: Decalf Veerle
role: STUDY_CHAIR
References: