TAPP: Vaginal Native Tissues Repair for Pelvic Organ Prolapse

Sponsor

University Hospital, Limoges (Other)

Overall Status

Recruiting

CT.gov ID

NCT03875989

Collaborator

(none)

214

Enrollment

Locations

Arms

Anticipated Duration (Months)

23.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prolapse, Vaginal	Procedure: Anterior colporraphy Procedure: vaginal patch plastron	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

214 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Vaginal Native Tissues Repair for Pelvic Organ Prolapse

Actual Study Start Date :

Sep 11, 2019

Anticipated Primary Completion Date :

Sep 11, 2023

Anticipated Study Completion Date :

Sep 11, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A	Procedure: Anterior colporraphy 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.
Experimental: Arm B	Procedure: vaginal patch plastron 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.

Arm

Intervention/Treatment

Active Comparator: Arm A

Procedure: Anterior colporraphy

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.

Experimental: Arm B

Procedure: vaginal patch plastron

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.

Outcome Measures

Primary Outcome Measures

Rate of the prolapse surgery [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)

Secondary Outcome Measures

Rate of the prolapse surgery [1 year]
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)
Rate of post-operative complications [45 Days]
Rate of post-operative complications according to the Clavien-Dindo classification 45 days after the surgery by the patient's surgeon (not blinded)
Sexual function [1 year]
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
Rate of the prolapse surgery [2 years]
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)
Rate of the prolapse surgery [3 years]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 .

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Bordeaux	Bordeaux	France	33000
2	CH de Brive	Brive-la-Gaillarde	France	19100
3	CHU de Clermont Ferrand	Clermont-Ferrand	France	63100
4	CH de Gueret	Guéret	France	23000
5	CHU de Limoges	Limoges	France	87000
6	CHU de Saint-Etienne	Saint-Étienne	France	42000
7	CHU de Toulouse - Paule de Viguier	Toulouse	France	31059
8	CHU de Toulouse - Rangueil	Toulouse	France	31400
9	CH de Tulle	Tulle	France	19000