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

25 november 2013 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Bäckenorgan framfall

Studietyp

Observationell

Inskrivning (Faktisk)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
vita sexualis Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
pain during sexual intercourse Tidsram: 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 Tidsram: 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 Tidsram: 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) Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Dr. med. Tanja Hülder

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2011

Primärt slutförande (Faktisk)

1 april 2013

Avslutad studie (Faktisk)

1 oktober 2013

Studieregistreringsdatum

Först inskickad

29 oktober 2013

Först inskickad som uppfyllde QC-kriterierna

25 november 2013

Första postat (Uppskatta)

28 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)