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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vita sexualis	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain during sexual intercourse	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	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	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)	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	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

Collaborators and Investigators

• Sponsor: Dr. med. Tanja Hülder
• Investigators: Study Chair: Tanja Hülder, Dr.med., Cantonal Hospital of St. Gallen

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): November 28, 2013
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Pelvic Organ Prolapse; PROLIFT+M; Vita sexualis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: CTU 10/038