Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03558802 |
| Other study ID # |
NL67503.042.18 |
| Secondary ID |
201800687 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 16, 2019 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
University Medical Center Groningen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Rationale: Pelvic floor symptoms (PFS) are prevalent and often impair quality of life. They
include micturition problems, defecation problems, pelvic organ prolapse, sexual problems and
genito-pelvic pain. The pelvic floor is an anatomical and functional unit, and therefore
different PFS may co-occur. However, literature on prevalence of clusters of PFS is scarce.
Furthermore, PFS is understudied in the male population and when studies are performed in
male subjects, studies do not assess the complete scope of possible PFS.
Objective: To generate a cohort, which provides information on sex- and gender differences
in: prevalence and incidence of (clinically relevant clusters of) PFS, risk factors and
prognostic factors for PFS, factors that reveal the impact of PFS on daily life, help seeking
behavior and use of health care.
Study design: Prospective observational population-based cohort study with follow-up moments
after 1 year and 2 years. Data of the questionnaire will be connected to medical record data
from the participating general practitioners (GPs). A representative sample of female and
male subjects with and without PFS will be invited for a physical examination to assess
pelvic floor disorders and muscle function. Furthermore, a subsample of patients will be
invited for a qualitative study consisting of semi-structured interviews on healthcare
seeking behavior, including barriers and facilitators, preferences and satisfaction.
Study population: female and male subjects, aged ≥16 years of age, from the general
population will be included. Exclusion criteria are: terminal disease, or dementia, cognitive
impairment or current psychological condition precluding informed consent, not suitable or
too ill to participate based on the judgement of the GP.
Main study parameters: To evaluate the sex- and gender difference in prevalence and incidence
of (clinically relevant clusters of) PFS, the following primary parameters are assessed:
lower urinary tract symptoms, bowel symptoms, urogenital prolapse (females only), sexual
functioning, and pain. Secondary study parameters are factors associated with the development
of PFS ('risk factors'), factors that predict the course of PFS ('prognostic factors'),
factors that reveal the impact of PFS on daily life, help seeking behavior, and health care
use (consultations for PFS and consultation frequency, diagnostic tests, diagnoses,
treatment, and referrals).
Description:
Primary Objective:
To explore sex- and gender differences in:
1. the prevalence of (clinically relevant clusters) of PFS
2. the incidence of (clinically relevant clusters) of PFS
Secondary Objectives:
To explore sex- and gender differences in:
3. factors associated with the development of PFS ('risk factors')
4. factors that predict the course of PFS ('prognostic factors')
5. factors that reveal the impact of PFS on daily life
6. help seeking behavior
7. health care use (consultations for PFS and consultation frequency, diagnostic tests,
diagnoses, treatment, and referrals) among those who sought care.
Design:
For this study a mixed-methods approach will be used, combining quantitative and qualitative
study designs.
The first step is to set-up a prospective population-based cohort study with a 2-year
follow-up based on annual self-administered questionnaires. Eligible participants will be
invited by general practices in a well-defined region: the municipality of Coevorden.
Electronic medical record data (extracted from the Huisartsen Informatie Systeem, HIS) will
be matched with outcomes of the questionnaire, by a trusted third party (TTP).
A sample of female (n=200) and male (n=200) subjects with and without PFS will be invited for
physical examination to assess pelvic floor disorders and pelvic floor muscle function (sub
study 1).
A sample of patients with PFS will be invited for a qualitative study consisting of a
semi-structured interview on help seeking behavior, including barriers and facilitators,
preferences and satisfaction (sub study 2).
Procedures:
In the upcoming period before the baseline questionnaire the study will be given attention by
flyers/posters in the waiting room of the participating practices and local press.
Eligible persons will receive an information letter, with informed consent form attached,
from their GP about the cohort study.
Informed consent:
People can provide informed consent by sending a signed informed consent form to the
coordinating investigator using the pre-stamped and self-addressed envelope included.
Subjects will be asked to fill in the informed consent form for
1. participation in the cohort study (i.e. filling in the questionnaire),
2. permission to collect medical GP record data
3. permission to be approached for future sub-studies
Filling in the questionnaire:
After providing informed consent, participants will receive an e-mail including the
website of the questionnaire and their unique personal code for filling in the
questionnaire.
When subjects have not finished the questionnaire within 2 weeks, they will receive an
automatically generated reminder by e-mail. When 1 week after the e-mail reminder, the
subject has not finished the questionnaire, a second reminder by SMS will be sent. If a
subject will not respond to these reminders, he/she will be considered as nonresponder
(baseline) or lost to follow up.
The questionnaire consists of 11 parts for women and 10 parts for men, with a filling in
time of approximately 45-60 minutes. Subjects may interrupt completing the questionnaire
and continue it later on. In the online version there will be a button that enables
completing the questionnaire in another time (details on the questionnaire can be found
in the Methods section of this protocol). The questions in the online questionnaire will
have audio support, to stimulate participation and prevent drop-out of participants with
low literacy.
Subjects, who do not have access to the internet can use a laptop of the research team,
made available in the local general practice (in a private room). Subjects who indicated
that they want to fill in a paper version of the questionnaire will receive a paper
version at their home address including a pre-stamped and self-addressed envelope. The
paper questionnaires (provided only with the subject identification code) will be
entered into the online RoQua system by the coordinating researcher or research
assistant.
In case participants need support with filling in the questionnaires, such support is
provided through the research team in the municipality of Coevorden. For this, medical
students (males and females) with different native languages will be deployed. Due to
the privacy sensitive nature of the study, we actively discourage participants to ask
support from their peers or family.
Invitation and procedure for sub-studies Eligible participants (see information on
sub-studies), who provided informed consent for receiving information on sub-studies,
will receive a participant information leaflet for the specific sub-study.
Sub study 1 physical examination When participants (at least 21 years old) want to
participate they fill in the reply form and send it to the research team. A member of
the research team will schedule an appointment for the physical examination. The
participant and a member of the study team will sign informed consent face to face
before the start of the physical examination.
Sub study 2 interview When participants want to participate they fill in the informed
consent form and send it to the research team. A member of the research team will
schedule an appointment for the interview.
Follow-up:
Participants who completed the baseline questionnaire will be invited after 1 year and
after 2 years to participate in the follow-up questionnaire rounds.
Data:
1. List with potential participants (key file) In order to invite subjects (after
informed consent), to send reminders to the subjects, and to eventually connect the
questionnaire database with the medical record data, this data file contains information
about sex, name, date of birth, address, postal code, place, email-address, and
telephone number. Furthermore, preference of way of filling in the questionnaire (online
or paper, with or without guidance), and permission to collect medical GP record data,
and permission to be approached for future sub-studies will be included in this data
file.
A subject identification code will be made for each subject. This code is not based on
patient initials and birth-date. The data file is safeguarded by the coordinating
investigator and the research assistant that is part of the research team, and will be
stored in a separate place apart from other files, without access from outside. A
password will be needed for entering this key file.
2a. Data file with personal data In order to connect subjects to the questionnaire
database, and to send reminders to the subjects, this data file contains information
about sex, name, email-address, telephone number and the subject identification number.
This system with personal data will be filled in by predefined research members (i.e.
the coordinating researcher and research assistant of the study) and access to the
system is restricted to those predefined research members. Next to a login account, the
system is secured by Google Authenticator. The predefined research members have
restricted options, such as filling in the personal data and inviting subjects for
filling in the questionnaire.
2b. Questionnaire database RedCap will be used to collect and store data generated from
the questionnaires. Data are stored servers under the management of 'het Centrum voor
Informatie Technologie (CIT)' of the RuG. The database is not directly accessible for
the researcher, but will be made available to the researcher according to the approved
Research Data management plan. Data will not be anonymized, but pseudonymized as it is
necessary to trace data to an individual subject. This procedure will be performed by a
Trusted Third Party (ZorgTTP).
3. Medical data GPs Medical data will be collected through the electronic medical
records (Huisarts Informatie Systeem, HIS) systems used by the different general
practices. Data from those HIS systems will be collected via VIPLive and transformed by
Calculus/Proigia in order to generate a generic structure of the data. The structured
data will then be returned to VIPLive and will be sent to ZorgTTP for pseudomization.
The pseudonymized data are sent to the AHON (Academisch Huisarts Ontwikkel Netwerk)
database. The time scale for medical record review is 5 years prior to baseline
measurement up to the end of follow-up in the cohort.
4. Research database The different databases (questionnaire database and a subset of the
AHON database) can be connected via the unique pseudomization codes provided by ZorgTTP,
eventually resulting in a secured research database. This raw data file will be locked
for editing after closure of the study. Data cleaning and processing will be executed
using syntaxes in program SPSS.
Monitoring and Quality Assurance:
As this study is with negligible risks a monitor from the University Medical Center
Groningen (UMCG) will monitor the study.
Statistical analysis:
Primary study parameter(s):
To identify distinct classes of patients with clinically relevant clusters of PFS we
will perform Latent Class Analyses (LCA). LCA is a type of cluster analysis used to
group patients into k number of unique categories, where, within each category patients
are most similar to each other regarding PFS, and between the categories patients are
most different. The prevalence and incidence of those clinically relevant clusters of
PFS will be calculated.
To explore whether sex- and gender-differences are present, we will perform most of the
analyses separately for sex (male and female subjects). The main reason for this is that
the questionnaires to measure PFS among women (female subjects) and men (male subjects)
are different to each other.
Secondary study parameter(s):
Univariate analyses will be performed to assess which parameters will be used in the
multivariable regression-analyses. In addition to those univariate parameters,
parameters known from literature will be added to the regression models.
Multivariable regression-analyses will be used to assess which factors are associated
with cluster membership. We aim to distinguish factors associated with the development
of PFS ('risk factors'), factors that predict the course of PFS ('prognostic factors'),
factors that reveal the impact of PFS on daily life, and explore sex and gender
differences.
To determine which factors are potential risk factors, a subsample consisting of
participants without PFS at baseline will be selected.
Multivariable regression-analyses will be used to identify baseline factors that are
associated with the development of PFS at follow-up measurements. To determine which
factors are prognostic factors, a subsample consisting of participants reporting PFS at
baseline will be selected. Subsequently, a predictive model will be made to assess which
characteristics are associated to the course of (clusters of PFS) during follow-up. To
explore whether sex- and gender-differences are present, we will perform most of the
analyses separately for sex (male and female subjects). The main reason for this is that
the questionnaires to measure PFS among women (female subjects) and men (male subjects)
are different to each other. We would introduce bias if we would use the complete set of
data and add sex as interaction term in the regression analyses. To explore the
influence of gender-specific variables, we will add the gender identity variable and
gender role variables in the regression analyses.
Variables will be entered into the model using the ''enter'' method of regression (ie,
all variables are forced into the model simultaneously, without making a decision about
the order in which the variables are entered.
