Trial document




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  DRKS00017032

Trial Description

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Title

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

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Trial Acronym

Cervicosacropexy with DynaMesh®-PRS soft visible

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URL of the Trial

http://none

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Brief Summary in Lay Language

The purpose of the observational study is assessment of 1. sexuality, 2. reconstruction of the anatomical conditions of the female genital organs (vagina, uterus, bladder and rectum), 3. descensus symptoms, 4. quality of life, 5. urinary incontinence before and after pelvic floor surgery in the anterior and apical compartments (anterior colprrhaphy + cervicosacropexy)

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Brief Summary in Scientific Language

The study's aim is to demonstrate that the use of a PVDF-mesh allows for a reduction of preoperative sexual dysfunction by at least 65%, compared to the 50% reduction found with conventional PP-meshes.

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Organizational Data

  •   DRKS00017032
  •   2019/03/27
  •   [---]*
  •   yes
  •   Approved
  •   2018-539-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N81 -  Female genital prolapse
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Interventions/Observational Groups

  •   Monocentric, single-cohort, prospective observational study with patients with symptomatic vaginal descensus and cystocele
    Patients are asked to complete questionnaires before surgery, 6 months and 12 months after the operation:
    1. P-QOL (decensus symptoms)
    2. UDI 6 (incontinence complaints)
    3. FSFI-d (questionnaire sexual dysfunction).
    Furthermore, data are collected on demographics, anamnesis.
    In addition, a gynecological examination determines the anatomical correction of the apical uterine prolapse.
    To confirm safety of the product (mesh) and the surgical procedure, all complications associated with surgery and mesh implantation are recorded.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/04/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Evangelische Krankenhaus Hagen Haspe
    • Mr.  Dr. med. dr hab.  Jacek  Kociszewski 
    • Brusebrinkstr. 20
    • 58135  Hagen
    • Germany
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    • FEG Textiltechnik mbH
    • Mr.  Dr. Ing.  Philipp  Schuster 
    • Prager Ring 70
    • 52070  Aachen
    • Germany
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    • Evangelische Krankenhaus Hagen Haspe
    • Mr.  Dr. med. dr hab.  Jacek  Kociszewski 
    • Brusebrinkstr. 20
    • 58135  Hagen
    • Germany
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Sources of Monetary or Material Support

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    • Evangelische Krankenhaus Hagen Haspe
    • Mr.  Dr. med. dr hab.  Jacek  Kociszewski 
    • Brusebrinkstr. 20
    • 58135  Hagen
    • Germany
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    • FEG Textiltechnik mbH
    • Mr.  Dr. Ing.  Philipp  Schuster 
    • Prager Ring 70
    • 52070  Aachen
    • Germany
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    end of 1:1-Block address contact otherSupport
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Prüfplan
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* This entry means the parameter is not applicable or has not been set.