Prospective observational study on sexual dysfunction after pelvic floor surgery in the anterior compartment (anterior colporrhaphy) and apical compartment (cervicosacropexy) with the PVDF-Mesh DynaMesh®-PRS soft visible

Prospective observational study on sexual dysfunction after pelvic floor surgery in the anterior compartment (anterior colporrhaphy) and apical compartment (cervicosacropexy) with the PVDF-Mesh DynaMesh®-PRS soft visible - Cervicosacropexy with DynaMesh®-PRS soft visible

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017032

Enrollment

100

Registered

2019-03-27

Start date

2019-04-01

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

N81

Interventions

Group 1: Monocentric, single-cohort, prospective observational study with patients with symptomatic vaginal descensus and cystocele Patients are asked to complete questionnaires before surgery, 6 mont

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Women with symptomatic vaginal descensus. Symptomatic descensus is defined as POPQ > I° including clinical symptoms (descensus, foreign body sensation, cystitides, micturition problems) accompanied by cystocele > I°. 2. Women of at least 18 years of age 3. Patient´s informed consent to data collection, therapy, and follow-up examinations. 4. No significant improvement after conservative treatment (pelvic floor exercise, pessary, local estrogen) or decline of conservative treatment. 5. No further desire to have children.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or desire to have children 2. Unwilling or unable to participate in follow-up examinations 3. Severe cervical dysplasia (CIN > II) 4. Asymptomatic uterovaginal descensus 5. Patients with ASA > 2 (according to American Society of Anaesthesiologists score) 6. Previous non-supracervical hysterectomy 7. Desire to preserve uterus 8. Existing anterior or posterior enterocele or rectocele > I° 9. Ongoing ocological treatment 10. BMI > 40 11. Deep endometriosis IV° 12. Patients held at an institution on judicial or governmental order.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the objective change of sexual dysfunction after treatment with a PVDF (polyvinylidene fluoride) implant. In order to do so, the FSFI-questionnaire (female sexual function index) will be evaluated preoperatively, as well as 6 and 12 months postoperatively, and compared.	—

Secondary

Measure	Time frame
Secondary endpoints are: • Objective cure rate (POP-Q) • Subjective cure rate • Urinary incontinence (UDI-6 Questionnaire) • Quality of life (P-QOL) • Peri- and postoperative complications (according to Clavien-Dindo)	—

Countries

Germany

Contacts

Public ContactJacek Kociszewski

Evangelische Krankenhaus Hagen Haspe

gyn@evk-haspe.de02331 476201

Outcome results

None listed

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