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ProViS (Prolift+M and Vita Sexualis) Study (ProViS)

25. november 2013 opdateret af: Dr. med. Tanja Hülder

ProViS (Prolift+M TM and Vita Sexualis) Study

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.

Studieoversigt

Status

Afsluttet

Betingelser

Prolaps af bækkenorganer

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Schweiz
- - St.Gallen, Schweiz, 9007
    - Kantonsspital St.Gallen
Tyskland
- Bayern
  - Augsburg, Bayern, Tyskland, 86156
    - Klinikum Augsburg
- Saarland
  - Homburg/Saar, Saarland, Tyskland, 66424
    - Universitatsklinikum des Saarlandes
- Sachsen
  - Chemnitz, Sachsen, Tyskland, 09117
    - Drk Krankenhaus Chemnitz-Rabenstein

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients visiting specialist in hospitals and specialized doctor's offices scheduled to undergo Prolapse surgery.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
vita sexualis Tidsramme: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative	No worsening in vita sexualis (decrease in total score Female Sexual Function Index (FSFI-d) of ≤ 3.3; max. score = 36) measured at 12 months (+/- 1 month) postoperatively as compared to the preoperative score.	7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
pain during sexual intercourse Tidsramme: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative	No worsening in pain during sexual intercourse (decrease in weighted pain subscore FSFI-d of ≤ 1; max score = 6) measured at 12 months (+/- 1 month) postoperatively compared to preoperative.	7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
Assessment of pelvic floor function Tidsramme: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative	Assessment of pelvic floor function using the validated German pelvic floor questionnaire at 12 months (+/- 1 month) postoperatively compared to preoperative (Deutscher Beckenboden-Fragebogen, validated German Version of the Australian Pelvic Floor Questionnaire	7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
Assessment of patient satisfaction Tidsramme: 12 months (+/- 1 month) Postoperative	Assessment of patient satisfaction at 12 months (+/- 1 month) postoperatively using the visual analogue scale (VAS), question regarding reoperation and patient global (PGI) question.VAS: On top of two scales, the question "How satisfied are you with the result of your operation?" is placed. (Facial expressions are put above the line to express satisfaction visually). In addition, the following two questions are asked: "Would you have the operation done again?" and "In the past 12 months how would you rate your condition as opposed to before your recent pelvic floor operation: much better/a little better/about the same/a little worse/much worse" (PGI question).	12 months (+/- 1 month) Postoperative
Assessment of recurrent POP (POP-Q ≥ stage II) Tidsramme: 3 months (12 weeks +/- 2) and 12 months (+/- 1 month) postoperatively	Assessment of recurrent POP (POP-Q ≥ stage II in the operated compartment(s)), mesh erosion/exposure; each measured 3 (12 +/- 2 weeks) and 12 months (+/- 1 month) postoperatively by clinical examination (Speculum, palpation, POP-Q)	3 months (12 weeks +/- 2) and 12 months (+/- 1 month) postoperatively
Safety Tidsramme: until 12 months (+/- 1 month) postoperatively	Safety (documentation and assessment of medical device incidents; serious incidents and near incidents will be reported to the competent authorities)	until 12 months (+/- 1 month) postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dr. med. Tanja Hülder

Efterforskere

Studiestol: Tanja Hülder, Dr.med., Cantonal Hospital of St. Gallen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2011

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

29. oktober 2013

Først indsendt, der opfyldte QC-kriterier

25. november 2013

Først opslået (Skøn)

28. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)