Prolapse, VaginalTAPPNCT03875989
Vaginal Native Tissues Repair for Pelvic Organ Prolapse
A study testing Anterior colporraphy and vaginal patch plastron in people with Prolapse, Vaginal, run by University Hospital, Limoges at 9 sites in France.
Trial summary
The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Prolapse, Vaginal
- What is being tested?
- Anterior colporraphy and vaginal patch plastron
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 9 sitesFrance
- Study dates
- 27 Sep 2019to 27 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at 50 years of age or older
- Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and/or Ba points ≥0 according to the POP-Q system
- A positive response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the PFDI-20)
- Able to give informed consent
- Performans Status score ≤ 2
Who cannot join
- Patient with need for surgical treatment for myorraphy of levator ani muscles
- Patient with previous surgical cystocele repair.
- Patient with evolving gynaecologic cancer.
- Pregnancy or wish for future pregnancy, lactating woman.
- Inability to participate in study follow-up or to provide informed consent.
- Lack of social insurance .
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Claude HOCKE, MD, claude.hocke@chu-bordeaux.fr
Claude HOCKE, MD
- Recruiting
CH de Brive
Brive-la-Gaillarde, 19100
Christelle MESNARD, MD, mesnardc@yahoo.fr
Christelle MESNARD, MD
- Recruiting
CHU de Clermont Ferrand
Clermont-Ferrand, 63100
Sandrine CAMPAGNE, MD, scampagne-loiseau@chu-clermontferrand.fr
Sandrine CAMPAGNE, MD
- Recruiting
CH de Gueret
Guéret, 23000
Yves AUBARD, MD, yves.aubard@chu-limoges.fr
Yves AUBARD, MD
- Recruiting
CHU de Limoges
Limoges, 87000
Aymeline LACORRE, MD, aymeline.lacorre@chu-limoges.fr
Tristan GAUTHIER, MD, tristan.gauthier@chu-limoges.fr
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42000
Céline CHAULEUR, MD, celine.chauleur@chu-st-etienne.fr
Céline CHAULEUR, MD
- Recruiting
CHU de Toulouse - Paule de Viguier
Toulouse, 31059
Hélène POL, MD, helene.pol@chu-toulouse.fr
Fabien VIDAL, MD
- Recruiting
CHU de Toulouse - Rangueil
Toulouse, 31400
Elodie CHANTALAT, MD, chantalat.e@chu-toulouse.fr
Elodie CHANTALAT, MD
- Recruiting
CH de Tulle
Tulle, 19000
François SIEGERTH, MD, FSIEGERTH@ch-tulle.fr
About this study
The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.
Read the detailed description
Pelvic organ prolapse is usually the result of loss of pelvic support. It is widely accepted that 50% of women after 50 years old will develop prolapse, evaluated through the POPQ Classification . Pelvic organ prolapse cause significant psychological distress and negatively affect quality of life. Among the surgery for prolapse, the cystocele cureis is the most frequent (67.7%). Native tissue cystocele repairs is the cornerstone of prolapse surgery especially since the learned societies (Food and Drug Administration, Haute Autorité de Santé, Collège National des Gynécologues-Obstétriciens Français) warned clinicians and patients about serious mesh related complications. In France, 41.5% of vaginal cystocele repair are with native tissue. The main surgeries are anterior colporraphy and vaginal patch plastron, used in routine in our center with re-intervention rates less than 4% at one year. Rate of success of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. A prospective study find a success rate at 35% of the anterior colporraphy based on a combined definition, anatomic and functional as recommended recently. However the definition of anatomic was strict (POPQ<2), while it seems that the best definition of anatomic success is "no prolapse among the hymen", that is to say aAa and Ba points <0.
We think that the vaginal patch plastron will have a better anatomic and functional success comparatively to the anterior colporraphy as it corrects median cystoceles by a vaginal strip as well as lateral cystoceles by the bilateral paravaginal suspension.
The description of the two surgeries will be standardized between all the surgeons. We will compare the anterior colporraphy consisting in bladder median support by retensioning Halban fascia with colpectomy to the vaginal patch plastron consisting in making a vaginal strip attached to the bladder combined with suspension by fixation of the vaginal strip to the tendinous arch of the pelvic fascia.
Patients will be blind of their surgery. They will have a follow-up visit 45 days after the surgery to evaluate the post- operative complications according to the Clavien-Dindo classification. They will have phone call at 4 and 8 months after the surgery to make sure they've not suffered for complications. At last, they will have a follow-up visit 1 year after the surgery by an independent assessor blind of the surgery to evaluate the primary outcome (anatomic and functional success).
- Conditions
- Prolapse, Vaginal
- Being tested
- Anterior colporraphy, vaginal patch plastron
- Keywords
- Prolapse, Vaginal native tissues repair, Pelvic organ
- Medical subject headings
- Uterine Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior colporraphyProcedure or surgery
It will be delimitate a rectangular vaginal strip which will be isolated from the anterior colpocele. The superior edge of the strip is placed 2 cm from the urethral orifice. After lateral vesico-vaginal dissection, the paravesical fossae will be wide opened to repair the tendinous arches. The vaginal plastron will be fixed to the tendinous arch of the pelvic fascia by 3 lateral stitches (anterior/ lateral/ posterior) on each side of the plastron. After, the plastron will be tensioning and the cystocele will be suspended. The closure of the vaginal wall will end the procedure.
vaginal patch plastronProcedure or surgery
It will be make a midline incision of the anterior vaginal wall from the urethrovesical junction to the vaginal apex or anterior fornix. The vaginal epithelium will be separated from the underlying fibromuscular layer (Halban Fascia) after the midline incision. Midline plication of the fibromuscular layer will be obtained by interrupted horizontal stiches. The closure of the vaginal wall will end the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Not described Receives: Procedure: Anterior colporraphy |
| Arm B | Experimental | Not described Receives: Procedure: vaginal patch plastron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the prolapse surgery
The success rate of the prolapse surgery defined by a composite of objective and subjective measures:
- Anatomic success defined by Aa and Ba values <0 in Pelvic Organ Prolapse Quantification System (POP-Q) AND
- Subjective success through reliable condition-specific quality-of-life questionnaires:
- A negative response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the Pelvic Floor Distress Inventory (PFDI-20)) AND
- Range score of Patient Global Impression of Improvement (PGI-I) 1 or 2 AND
- No need for other treatment for prolapse (surgical nor medical)
Measured: 1 year
Secondary outcomes (5)
Rate of the prolapse surgery
The failure rate of the prolapse surgery defined by a composite of objective and subjective measures:
- Recurrent prolapse defined by Aa and/or Ba values > or= 0 in POP-Q OR
- Subjective failure through reliable condition-specific quality-of-life questionnaires:
- A positive response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the PFDI-20) OR
- A PGI-I score > 2 OR
- Need of a new treatment for prolapse (surgical or medical)
Measured: 1 year
Rate of post-operative complications
Rate of post-operative complications according to the Clavien-Dindo classification 45 days after the surgery by the patient's surgeon (not blinded)
Measured: 45 Days
Sexual function
The sexual function improvement will be evaluated by the difference in PISQ 12 score (condition-specific quality-of-life questionnaire) between the inclusion and one year after the surgery for sexually active women
Measured: 1 year
Rate of the prolapse surgery
The failure rate of the prolapse surgery defined by a composite of objective and subjective measures:
- Recurrent prolapse defined by Aa and/or Ba values > or= 0 in POP-Q OR
- Subjective failure through reliable condition-specific quality-of-life questionnaires:
- A positive response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the PFDI-20) OR
- A PGI-I score > 2 OR
- Need of a new treatment for prolapse (surgical or medical)
Measured: 2 years
Rate of the prolapse surgery
The failure rate of the prolapse surgery defined by a composite of objective and subjective measures:
- Recurrent prolapse defined by Aa and/or Ba values > or= 0 in POP-Q OR
- Subjective failure through reliable condition-specific quality-of-life questionnaires:
- A positive response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the PFDI-20) OR
- A PGI-I score > 2 OR
- Need of a new treatment for prolapse (surgical or medical)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start27 Sep 2019
- Primary completion27 Sep 2025 (estimated)
- Study completion27 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolapse, VaginalStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, parallel-group randomised controlled trial (1:1), multicentric. The primary outcome and the secondary outcome 1 and 3 will be evaluated in double blind; only the secondary outcome 2 will not be evaluated in blind.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875989
- Sponsor's protocol ID
- 87RI18_0013 (TAPP)
- Acronym
- TAPP
- Status last verified
- Aug 2023
- First submitted
- 13 Mar 2019
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lacorre A, Vidal F, Campagne-Loiseau S, Marin B, Aubard Y, Siegerth F, Mesnard C, Chantalat E, Hocke C, Gauthier T. Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial. Trials. 2020 Jul 8;21(1):624. doi: 10.1186/s13063-020-04512-x.
PubMed 32641096
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Native Tissues Repair for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT03875989
- Acronym / sponsor ID
- TAPP / 87RI18_0013 (TAPP)
- Conditions
- Prolapse, Vaginal
- Keywords
- Prolapse, Vaginal native tissues repair, Pelvic organ
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 27 Sep 2025 (estimated)
- Study completion
- 27 Mar 2028 (estimated)
- First posted
- 15 Mar 2019 (actual)
- 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.
The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.
Detailed description
Pelvic organ prolapse is usually the result of loss of pelvic support. It is widely accepted that 50% of women after 50 years old will develop prolapse, evaluated through the POPQ Classification . Pelvic organ prolapse cause significant psychological distress and negatively affect quality of life. Among the surgery for prolapse, the cystocele cureis is the most frequent (67.7%). Native tissue cystocele repairs is the cornerstone of prolapse surgery especially since the learned societies (Food and Drug Administration, Haute Autorité de Santé, Collège National des Gynécologues-Obstétriciens Français) warned clinicians and patients about serious mesh related complications. In France, 41.5% of vaginal cystocele repair are with native tissue. The main surgeries are anterior colporraphy and vaginal patch plastron, used in routine in our center with re-intervention rates less than 4% at one year. Rate of success of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. A prospective study find a success rate at 35% of the anterior colporraphy based on a combined definition, anatomic and functional as recommended recently. However the definition of anatomic was strict (POPQ<2), while it seems that the best definition of anatomic success is "no prolapse among the hymen", that is to say aAa and Ba points <0.
We think that the vaginal patch plastron will have a better anatomic and functional success comparatively to the anterior colporraphy as it corrects median cystoceles by a vaginal strip as well as lateral cystoceles by the bilateral paravaginal suspension.
The description of the two surgeries will be standardized between all the surgeons. We will compare the anterior colporraphy consisting in bladder median support by retensioning Halban fascia with colpectomy to the vaginal patch plastron consisting in making a vaginal strip attached to the bladder combined with suspension by fixation of the vaginal strip to the tendinous arch of the pelvic fascia.
Patients will be blind of their surgery. They will have a follow-up visit 45 days after the surgery to evaluate the post- operative complications according to the Clavien-Dindo classification. They will have phone call at 4 and 8 months after the surgery to make sure they've not suffered for complications. At last, they will have a follow-up visit 1 year after the surgery by an independent assessor blind of the surgery to evaluate the primary outcome (anatomic and functional success).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Experimental, parallel-group randomised controlled trial (1:1), multicentric. The primary outcome and the secondary outcome 1 and 3 will be evaluated in double blind; only the secondary outcome 2 will not be evaluated in blind.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Procedure: Anterior colporraphy |
| Arm B | Experimental | Procedure: vaginal patch plastron |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient at 50 years of age or older
- Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and/or Ba points ≥0 according to the POP-Q system
- A positive response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the PFDI-20)
- Able to give informed consent
- Performans Status score ≤ 2
Key exclusion criteria (6 listed)
- Patient with need for surgical treatment for myorraphy of levator ani muscles
- Patient with previous surgical cystocele repair.
- Patient with evolving gynaecologic cancer.
- Pregnancy or wish for future pregnancy, lactating woman.
- Inability to participate in study follow-up or to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior colporraphyIt will be delimitate a rectangular vaginal strip which will be isolated from the anterior colpocele. The superior edge of the strip is placed 2 cm from the urethral orifice. After lateral vesico-vaginal dissection, the paravesical fossae will be wide opened to repair the tendinous arches. The vaginal plastron will be fixed to the tendinous arch of the pelvic fascia by 3 lateral stitches (anterior/ lateral/ posterior) on each side of the plastron. After, the plastron will be tensioning and the cystocele will be suspended. The closure of the vaginal wall will end the procedure. | Procedure or surgery | Arm A |
| vaginal patch plastronIt will be make a midline incision of the anterior vaginal wall from the urethrovesical junction to the vaginal apex or anterior fornix. The vaginal epithelium will be separated from the underlying fibromuscular layer (Halban Fascia) after the midline incision. Midline plication of the fibromuscular layer will be obtained by interrupted horizontal stiches. The closure of the vaginal wall will end the procedure. | Procedure or surgery | Arm B |
Primary outcome
Rate of the prolapse surgery
Time frame: 1 year
The success rate of the prolapse surgery defined by a composite of objective and subjective measures: * Anatomic success defined by Aa and Ba values <0 in Pelvic Organ Prolapse Quantification System (POP-Q) AND * Subjective success through reliable condition-specific quality-of-life questionnaires: * A negative response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the Pelvic Floor Distress Inventory (PFDI-20)) AND * Range score of Patient Global Impression of Improvement (PGI-I) 1 or 2 AND * No need for other treatment for prolapse (surgical nor medical)
5 secondary outcomes
Rate of the prolapse surgery
Time frame: 1 year
Rate of post-operative complications
Time frame: 45 Days
Sexual function
Time frame: 1 year
Rate of the prolapse surgery
Time frame: 2 years
Rate of the prolapse surgery
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 32641096Lacorre A, Vidal F, Campagne-Loiseau S, Marin B, Aubard Y, Siegerth F, Mesnard C, Chantalat E, Hocke C, Gauthier T. Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial. Trials. 2020 Jul 8;21(1):624. doi: 10.1186/s13063-020-04512-x.
- Individual participant dataSharing planned: No
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior colporraphy and vaginal patch plastron in people with Prolapse, Vaginal, run by University Hospital, Limoges at 9 sites in France.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of the prolapse surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875989, which also lists 1 linked publication.
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 29 Aug 2023.