ProViS (Prolift+M and Vita Sexualis) Study

Pelvic Organ Prolapse Clinical Trial

— ProViS  

Official title:

ProViS (Prolift+M TM and Vita Sexualis) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997996
• Other study ID #: CTU 10/038
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: November 25, 2013
• Start date: May 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
Germany	Klinikum Augsburg	Augsburg	Bayern
Germany	DRK Krankenhaus Chemnitz-Rabenstein	Chemnitz	Sachsen
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar	Saarland
Switzerland	Kantonsspital St.Gallen	St.Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. med. Tanja Hülder

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes