Pelvic Floor Signs and Symptoms in Women and Men

NCT03558802 | Completed

• 2 other identifiers: NL67503.042.18201800687
• Study Type: observational
• Target: 1,691
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (5)

• sex- and gender differences in the prevalence of (clusters of) pelvic floor symptoms

  To evaluate the sex-and gender difference in prevalence of (clinically relevant clusters of) PFS, the following primary parameters are assessed: lower urinary tract symptoms, bowel symptoms, prolapse, sexual functioning, and pain.

  prevalence at baseline

• sex- and gender differences in the prevalence of (clusters of) pelvic floor symptoms

  To evaluate the sex-and gender difference in prevalence of (clinically relevant clusters of) PFS, the following primary parameters are assessed: lower urinary tract symptoms, bowel symptoms, prolapse, sexual functioning, and pain.

  prevalence after 1 year

• sex- and gender differences in the prevalence of (clusters of) pelvic floor symptoms

  To evaluate the sex-and gender difference in prevalence of (clinically relevant clusters of) PFS, the following primary parameters are assessed: lower urinary tract symptoms, bowel symptoms, prolapse, sexual functioning, and pain.

  prevalence after 2 years

• sex- and gender differences in the incidence of (clusters of) pelvic floor symptoms

  sex- and gender differences in the incidence of (clusters of) pelvic floor symptoms

  after 1 year

• sex- and gender differences in the incidence of (clusters of) pelvic floor symptoms

  sex- and gender differences in the incidence of (clusters of) pelvic floor symptoms

  after 2 years

Secondary Outcomes (5)

• risk factors

  at baseline, after 1 year, after 2 years

• prognostic factors

  at baseline, after 1 year, after 2 years

• impact of PFS on daily functioning

  at baseline, after 1 year, after 2 years

• help seeking behavior

  at baseline, after 1 year, after 2 years

• health care use

  at baseline, after 1 year, after 2 years

Interventions

questionnaire OTHER

questionnaire

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohort will be based on a community-dwelling population. The source population of the observational cohort study are people registered at a participating general practice.

You may not qualify if:

• The general practices will perform the selection of potential participants.
• A potential subject who meets any of the following criteria will not be invited for the prospective cohort study:
• terminal illnesses;
• cognitive impairment (e.g. due to dementia) precluding informed consent;
• current psychological condition precluding informed consent;
• not suitable or too ill to participate based on the judgement of the GP.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 AD, Netherlands

Location

Related Publications (1)

• Notenboom-Nas FJM, Knol-de Vries GE, Beijer L, Tolsma Y, Slieker-Ten Hove MCP, Dekker JH, van Koeveringe GA, Blanker MH. Exploring pelvic floor muscle function in men with and without pelvic floor symptoms: A population-based study. Neurourol Urodyn. 2022 Nov;41(8):1739-1748. doi: 10.1002/nau.24996. Epub 2022 Jul 25.

  PMID: 35876473 DERIVED

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marco H Blanker, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: coordinating investigator Postdoc researcher

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 15, 2018
• Study Start: May 16, 2019
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

NL (1)