Prospective multicenter post- marketing surveillance study for surgical pelvic floor reconstruction in the anterior compartment with the polypropylen mesh InGYNious

Prospective multicenter post- marketing surveillance study for surgical pelvic floor reconstruction in the anterior compartment with the polypropylen mesh InGYNious - InGYNious - AWB

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011657

Enrollment

250

Registered

2017-02-20

Start date

2014-09-10

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

N81.1 N81.2

Interventions

Group 1: Comparison of the anatomical and subjective outcome before and after mesh supported pelvic floor reconstruction with InGYNious mesh for cystocele.The patients have an indication for surgical

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: symptomatic cystocele according to ICS (international continence society) grade >= POPQ 2 (primary cystocele and recurrence) Compliance according to evaluation of data, therapy and follow- up Written consent form of patient

Exclusion criteria

Exclusion criteria: Asymptomatic prolapse of uterus age< 18 years missing written consent form lacling compliance according to evaluation of data, therapy and follow- up known incompatibility in regard to mesh products expectation of life less than period of review, ASA 4 progredient malignancy state after radiotherapy of the true pelvis chronic cortisone medication fibromyalgia, chronic pain syndrome, connective tissue disease, immunodeficiency

Design outcomes

Primary

Measure	Time frame
1)Evaluation of quality of life and sexuality pre- vs. post- operatively after surgical repair of cystocele with implantation of InGYNious mesh. The German Version of the P- QOL(Prolapse Quality of Life) questionnaire is used. The patients complete the questionnaire pre- operatively, after 6 and 12 months. 2) Determination of cystocele recurrence rate after implantation of InGYNious mesh. The quantiication of prolapse is ensued with the POP- Q (Pelvic Organ Prolapse Quantification)- system, published by Bump et al., 1996	—

Measure

Time frame

1)Evaluation of quality of life and sexuality pre- vs. post- operatively after surgical repair of cystocele with implantation of InGYNious mesh. The German Version of the P- QOL(Prolapse Quality of Life) questionnaire is used. The patients complete the questionnaire pre- operatively, after 6 and 12 months. 2) Determination of cystocele recurrence rate after implantation of InGYNious mesh. The quantiication of prolapse is ensued with the POP- Q (Pelvic Organ Prolapse Quantification)- system, published by Bump et al., 1996

—

Secondary

Measure	Time frame
Evaluation of intra- and post- operative side effects after repair of cystocele with InGYNious mesh	—

Countries

Germany

Contacts

Public ContactAndreas Brandt

Ortenau Klinikum Offenburg- Gengenbach

andreas.brandt@og.ortenau-klinikum.de07814723500

Outcome results

None listed

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