Clinical trial NCT03875989: Vaginal Native Tissues Repair for Pelvic Organ Prolapse
Official title: Vaginal Native Tissues Repair for Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolapse, Vaginal
Keywords: Prolapse
Vaginal native tissues repair
Pelvic organ
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 214
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 .

Primary outcomes:
measure: Rate of the prolapse surgery
timeFrame: 1 year
Secondary outcomes:
measure: Rate of the prolapse surgery
timeFrame: 1 year
measure: Rate of post-operative complications
timeFrame: 45 Days
measure: Sexual function
timeFrame: 1 year
measure: Rate of the prolapse surgery
timeFrame: 2 years
measure: Rate of the prolapse surgery
timeFrame: 3 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brive-la-Gaillarde
country: France
facility: CH de Brive
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Guéret
country: France
facility: CH de Gueret
city: Limoges
country: France
facility: CHU de Limoges
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Toulouse
country: France
facility: CHU de Toulouse - Paule de Viguier
city: Toulouse
country: France
facility: CHU de Toulouse - Rangueil
city: Tulle
country: France
facility: CH de Tulle
Study officials:
References:
citation: 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.