ProViS (Prolift+M and Vita Sexualis) Study

NCT01997996 | Completed DMC

• 1 other identifier: CTU 10/038
• Study Type: observational
• Target: 18
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse; PROLIFT+M; Vita sexualis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• pain during sexual intercourse

  7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative

• Assessment of pelvic floor function

  7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative

• Assessment of patient satisfaction

  12 months (+/- 1 month) Postoperative

• Assessment of recurrent POP (POP-Q ≥ stage II)

  3 months (12 weeks +/- 2) and 12 months (+/- 1 month) postoperatively

• Safety

  until 12 months (+/- 1 month) postoperatively

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. med. Tanja Hülder: lead

Study Sites (4)

Klinikum Augsburg

Augsburg, Bavaria, 86156, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, Saarland, 66424, Germany

Location

DRK Krankenhaus Chemnitz-Rabenstein

Chemnitz, Saxony, 09117, Germany

Location

Kantonsspital St.Gallen

Sankt Gallen, St.Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanja Hülder, Dr.med.

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. Tanja Hülder

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 28, 2013
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

CH (1); DE (3)