Pelvic Organ ProlapseProViSNCT01997996
ProViS (Prolift+M and Vita Sexualis) Study
An observational study of Pelvic Organ Prolapse, run by Dr. med. Tanja Hülder at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 18 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2011to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting specialist in hospitals and specialized doctor's offices scheduled to undergo Prolapse surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Klinikum Augsburg
Augsburg, Bavaria, 86156
DRK Krankenhaus Chemnitz-Rabenstein
Chemnitz, Saxony, 09117
Universitätsklinikum des Saarlandes
Homburg/Saar, Saarland, 66424
About this study
Official title: 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.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Organ Prolapse, PROLIFT+M, Vita sexualis
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
Secondary outcomes (5)
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.
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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)
Measured: until 12 months (+/- 1 month) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. med. Tanja Hülder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. med. Tanja Hülder, Cantonal Hospital of St. Gallen
- Investigators
- Tanja Hülder, Dr.med., Study chair, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997996
- Sponsor's protocol ID
- CTU 10/038
- Acronym
- ProViS
- Status last verified
- Nov 2013
- First submitted
- 29 Oct 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProViS (Prolift+M TM and Vita Sexualis) Study
- ClinicalTrials.gov ID
- NCT01997996
- Acronym / sponsor ID
- ProViS / CTU 10/038
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Organ Prolapse, PROLIFT+M, Vita sexualis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Dr. med. Tanja HülderUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting specialist in hospitals and specialized doctor's offices scheduled to undergo Prolapse surgery.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
pain during sexual intercourse
Time frame: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
Assessment of pelvic floor function
Time frame: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
Assessment of patient satisfaction
Time frame: 12 months (+/- 1 month) Postoperative
Assessment of recurrent POP (POP-Q ≥ stage II)
Time frame: 3 months (12 weeks +/- 2) and 12 months (+/- 1 month) postoperatively
Safety
Time frame: until 12 months (+/- 1 month) postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
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Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja Hülder, Dr.med. study chair
Cantonal Hospital of St. Gallen
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Dr. med. Tanja Hülder at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vita sexualis (time frame: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.