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

• Conditions: N81; Female genital prolapse

• Registration Number: DRKS00017032
• Lead Sponsor: Evangelische Krankenhaus Hagen Haspe

Brief Summary

A total of 86 patients were treated with the PVDF implant PRS for apical genital descensus during the study period. On average, the patients were 58 years old at the time of surgery. 70% of the patients presented with an apical POPQ of II. The proportion of patients with apical POPQ III or greater was 26%. After a follow-up period of 12 months, 98.8% of patients were anatomically healed (apical POPQ < II); no reoperations were necessary. 5 patients (5.8%) subjectively reported "renewed prolapse symptoms". Postoperative complications included infections (3, 3.5%), erosions (1, 1.2%), de novo SUI (4, 4.7%), de novo micturition disorders (7, 8.1%), hematomas (5, 5.8%), pain (3, 3.5%) and constipation symptoms in 3 cases (3.5%). With regard to sexual dysfunction, the evaluation of the FSFI questionnaires after 12 months showed that the FSFI score increased statistically significantly by 6% compared to the preoperative score. Looking at the changes in the score per patient, it can be seen that for 80% of the patients the postoperative score is greater than or equal to the preoperative score. In 3 cases (3.5%) there was a significant reduction in the FSFI score.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-27
• Study Completion: 2022-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 99

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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