Validation of the German version of the FIGO assessment scoring system (FASS) for women with pelvic floor dysfunction.

Validation of the German version of the FIGO assessment scoring system (FASS) for women with pelvic floor dysfunction. - German FASS Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013963

Enrollment

150

Registered

2018-02-08

Start date

2016-06-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N81.8 N39.3

Interventions

Group 1: Each patient that presents at the urogynecologic outpatient clinic is asked if she wants to participate in this trial. After written informed consent each patient will be examined by examiner

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Woman is treated at one of the study centers (Heidelberg / Freiburg / Ludwigshafen), woman has urogynecological symptoms in case of patient group and no urogynecological symptoms/prior surgeries or treatments in case of recruitment for control group, written informed consent, age 18 years or above.

Exclusion criteria

Exclusion criteria: Any event that prohibits data acquisition, woman does not give written informed consent, age below 18

Design outcomes

Secondary

Measure	Time frame
secondary goals: Besides validating FASS for the German speaking community we aim to correlate FASS with the clinical anamnestic data obtained and with the P-QoL questionnaire. To detect a correlation between the symptoms and the obtained scores a Spearman's correlation is evaluated. Resulting p-values will not be adjusted for multiplicity and will be interpreted descriptively.	—

Primary

Measure	Time frame
Main goal of the study: to demonstrate that the use of the German version of the FASS is feasible in German speaking urogynecologic centers. With this, the inter- and intrareader reliability is to be evaluated and the FASS system validity is evaluated by comparing symptomatic and not symptomatic women. A total of 100 patients is planned to be recruited (approximately 25 patients / year / participating center). A total control group of 50 women is to be recruited. statistical analysis is to performed with SPSS. The women's characteristics will be analyzed descriptively (median, mean, standard deviation, absolute/relative frequencies). Ordinal scaling of score parameters (median, quartile). To evaluate the inter-/intrareader reliability Cohen's Kappa coefficients with 95% confidence interval are estimated. POP quantification results obtained by clinically examining the women will be correlated with the physical examination parameter "P" determined by using the FASS system with Spearman's correlation coefficient. A coefficient of 1.0 describes the perfect relationship. A coefficient of >/= 0.7 is considered as acceptable. The content validity is evaluated by comparing the FASS scores between symptomatic and not symptomatic women by using the Mann-Whitney U test. To detect a correlation between the symptoms and the obtained scores a Spearman's correlation is evaluated. Intraindividual changes in filling out the FASS sheet will be detected via Wilcoxon signed rank test. Resulting p-values will not be adjusted for multiplicity and will be interpreted descriptively.	—

Measure

Time frame

Main goal of the study: to demonstrate that the use of the German version of the FASS is feasible in German speaking urogynecologic centers. With this, the inter- and intrareader reliability is to be evaluated and the FASS system validity is evaluated by comparing symptomatic and not symptomatic women. A total of 100 patients is planned to be recruited (approximately 25 patients / year / participating center). A total control group of 50 women is to be recruited. statistical analysis is to performed with SPSS. The women's characteristics will be analyzed descriptively (median, mean, standard deviation, absolute/relative frequencies). Ordinal scaling of score parameters (median, quartile). To evaluate the inter-/intrareader reliability Cohen's Kappa coefficients with 95% confidence interval are estimated. POP quantification results obtained by clinically examining the women will be correlated with the physical examination parameter "P" determined by using the FASS system with Spearman's correlation coefficient. A coefficient of 1.0 describes the perfect relationship. A coefficient of >/= 0.7 is considered as acceptable. The content validity is evaluated by comparing the FASS scores between symptomatic and not symptomatic women by using the Mann-Whitney U test. To detect a correlation between the symptoms and the obtained scores a Spearman's correlation is evaluated. Intraindividual changes in filling out the FASS sheet will be detected via Wilcoxon signed rank test. Resulting p-values will not be adjusted for multiplicity and will be interpreted descriptively.

—

Countries

Germany

Contacts

Public ContactKerstin A. Brocker

Universitätsfrauenklinik Heidelberg

kerstin.brocker@med.uni-heidelberg.de062215637977

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026