Prospectively randomised multicenter trial on the influence on mesh exposure rates of partially absorbable transobturatoric mesh after surgery for pelvic organ prolapse in the anterior compartment

Prospectively randomised multicenter trial on the influence on mesh exposure rates of partially absorbable transobturatoric mesh after surgery for pelvic organ prolapse in the anterior compartment - PARETO-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004566

Enrollment

200

Registered

2012-11-29

Start date

2007-04-30

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: Vaginal implantation of a non absorbable polypropylene mesh (Seratom E, company: Serag Wiessner, Naila, Germany) Group 2: Vaginal implantation of a partially absorbable polypropylene mesh (Se

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients were eligible for participation in the trial when they had a symptomatic cystocele > stage 2 or stage 2 in combination with a considerable lateral defect and risk factors for recurrent POP: chronic obstructive pulmonary disease, chronic obstipation, overweight.

Exclusion criteria

Exclusion criteria: age <18 yrs, imcompleted family planning, allergy to polypropylene, previous malignancy of lower urinary tract, genital organs or rectosigmoid, previous mesh implantation, missing informed consent, life expectancy <3 yrs or patients that could not ensure follow up visits over 3 years.

Design outcomes

Primary

Measure	Time frame
What: Vaginal mesh exposure rate Wann: 12 months postoperatively Wie: vaginale examination: visible parts of the mesh	—

Secondary

Measure	Time frame
Which other factors have an influence on mesh exposure rates? The following factors will be investigates: preoperatively: patients´charakteristics, proliferation of vaginal epithelium, bacterial colonisation of the vagina, molecularbiologic factors of the vaginal wall (e.g. collagen composition and adherence, extracellular matrix proteines) intraoperative: surgical technique (thickness of vaginal wall. lenght of colpotomy, simultaneous hysterectomy). 3, 12 and 36 months postoperatively: proliferation of vaginal epithelium, bacterial colonisation of the vagina Furthermore, the influence of the mesh used on pelvic floor related quality of life will be evaluated, using the "German pelvic floor questionnaire" (Deutscher Beckenbodenfragebogen, Baessler et al. 2004) and on prolapse recurrence rates (vaginal examination). Both items will be tested after 3,12 and 36 months.	—

Measure

Time frame

Which other factors have an influence on mesh exposure rates? The following factors will be investigates: preoperatively: patients´charakteristics, proliferation of vaginal epithelium, bacterial colonisation of the vagina, molecularbiologic factors of the vaginal wall (e.g. collagen composition and adherence, extracellular matrix proteines) intraoperative: surgical technique (thickness of vaginal wall. lenght of colpotomy, simultaneous hysterectomy). 3, 12 and 36 months postoperatively: proliferation of vaginal epithelium, bacterial colonisation of the vagina Furthermore, the influence of the mesh used on pelvic floor related quality of life will be evaluated, using the "German pelvic floor questionnaire" (Deutscher Beckenbodenfragebogen, Baessler et al. 2004) and on prolapse recurrence rates (vaginal examination). Both items will be tested after 3,12 and 36 months.

—

Countries

Germany

Outcome results

None listed

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