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Completed

NCT Number: NCT01997996

ProViS (Prolift+M 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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Klinikum Augsburg, Augsburg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. vita sexualis

    Time frame: 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.

Secondary outcomes

  1. pain during sexual intercourse

    Time frame: 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.

  2. Assessment of pelvic floor function

    Time frame: 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

  3. Assessment of patient satisfaction

    Time frame: 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).

  4. Assessment of recurrent POP (POP-Q ≥ stage II)

    Time frame: 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)

  5. Safety

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Dr. med. Tanja Hülder

Other

Registry information

Official study title

ProViS (Prolift+M TM and Vita Sexualis) Study

Acronym: ProViS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2013
Registry last updated
Nov 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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