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ProViS (Prolift+M and Vita Sexualis) Study

NCT ID: NCT01997996

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Organ Prolapse

Keywords

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Pelvic Organ Prolapse PROLIFT+M Vita sexualis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PROLIFT+M

Patients that undergo surgery due to prolapse POP ≥ stage II with PROLIFT+M device having had ≥ 2x/4 weeks sexual intercourse before surgery.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* The patient understands the nature and content of the trial
* POP ≥ stage II (according to the POP-Q system (18))
* Sexual intercourse ≥ 2x/4 weeks
* Written informed consent
* Negative pregnancy test in women of childbearing potential
* Women ≥ 18 years

Exclusion Criteria

* Concomitant surgery at the inner genitalis (e.g. colporrhaphy, sacrocolpopexy, sacrospinous fixation, hysterectomy); concomitant suburethral slings and bulking agents are allowed
* Unable to read or speak German
* Women \< 18 years
* Women who are pregnant or breastfeeding or planning future pregnancies
* Acute infection(s), e.g. untreated urogenital infections
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. med. Tanja Hülder

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Tanja Hülder

Dr. med. Tanja Hülder

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tanja Hülder, Dr.med.

Role: STUDY_CHAIR

Cantonal Hospital of St. Gallen

Locations

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Klinikum Augsburg

Augsburg, Bavaria, Germany

Site Status

Universitätsklinikum des Saarlandes

Homburg/Saar, Saarland, Germany

Site Status

DRK Krankenhaus Chemnitz-Rabenstein

Chemnitz, Saxony, Germany

Site Status

Kantonsspital St.Gallen

Sankt Gallen, St.Gallen, Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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CTU 10/038

Identifier Type: -

Identifier Source: org_study_id