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ProViS (Prolift+M and Vita Sexualis) Study

NCT01997996 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2013-11-28

No results posted yet for this study

Summary

Transvaginal meshes (TVM) are indicated for the treatment of pelvic organ prolapse (POP) where surgical intervention is necessary. Due to a potential risk of de novo dyspareunia, TVM are mainly used in postmenopausal women and in case of recurrent POP. PROLIFT+M (Trademark) is based on a highly flexible material which is partially absorbable. We suggest that PROLIFT+M has less impact on the vita sexualis than conventional TVM and could also be used for the treatment of younger and/or sexually active women. This study observes women who are routinely treated with PROLIFT+M with regard to their sexual function before and after the surgery. The hypothesis is that there is no worsening in vita sexualis with PROLIFT+M.

Conditions

  • Pelvic Organ Prolapse

Sponsors & Collaborators

  • Dr. med. Tanja Hülder

    lead OTHER

Principal Investigators

  • Tanja Hülder, Dr.med. · Cantonal Hospital of St. Gallen

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-04-30
Completion
2013-10-31

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01997996 on ClinicalTrials.gov