Multicenter observational study for evaluation of patients satisfaction and cure rate after insertion of the MicroGYNious TVT from AMI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00020588

Enrollment

250

Registered

2020-02-13

Start date

2019-06-01

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

N39.3

Interventions

Group 1: Cohort 1: 100 patients with isolated stress incontinence without simultaneous genital descent who receive a MicroGYNious Group 2: Cohort 2: 150 patients with stress urinary incontinence and a

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: - all patients for whom the operation is indicated - completion of the 18th year of life - compliance regarding data collection, therapy and follow-up

Exclusion criteria

Exclusion criteria: Exclusion criteria: - rigid urethra - pregnancy - OAB or mixed incontinence with predominant OAB - state after Radiotherapy - limited life expectancy / progressive malignant disease - chronic pain syndrome, fibromyalgia, immune defects, connective tissue disorders - intolerance to polypropylene

Design outcomes

Primary

Measure	Time frame
Patient satisfaction after 2 years Survey using the German pelvic floor questionnaire	—

Secondary

Measure	Time frame
Secondary endpoints are: • objective surgical result after 6 weeks, 6 months and every year up to 5 years postoperatively (cough test, residual urine, sonographic position of the tape) • subjective satisfaction / quality of life after 6 weeks, 6 months and every year up to 5 years postoperatively (German pelvic floor questionnaire + incontinence questionnaire ICIQ-SF) • postoperative painscore / the need of painmedication • length of hospitalization • complications: bladder or urethra injuries, revision surgery, bladder emptying disorder, hematoma	—

Measure

Time frame

Secondary endpoints are: • objective surgical result after 6 weeks, 6 months and every year up to 5 years postoperatively (cough test, residual urine, sonographic position of the tape) • subjective satisfaction / quality of life after 6 weeks, 6 months and every year up to 5 years postoperatively (German pelvic floor questionnaire + incontinence questionnaire ICIQ-SF) • postoperative painscore / the need of painmedication • length of hospitalization • complications: bladder or urethra injuries, revision surgery, bladder emptying disorder, hematoma

—

Countries

Germany

Contacts

Public ContactMiriam Deniz

UFK Ulm

miriam.deniz@uniklinik-ulm.de0731 500 58584

Outcome results

None listed

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