Vaginal Native Tissues Repair for Pelvic Organ Prolapse

NCT03875989 | Recruiting

• 1 other identifier: 87RI18_0013 (TAPP)
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 9

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.

Conditions

Prolapse, Vaginal

Keywords

Prolapse; Vaginal native tissues repair; Pelvic organ

Outcome Measures

Primary Outcomes (1)

• 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)

  1 year

Secondary Outcomes (5)

• Rate of the prolapse surgery

  1 year

• Rate of post-operative complications

  45 Days

• Sexual function

  1 year

• Rate of the prolapse surgery

  2 years

• Rate of the prolapse surgery

  3 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Procedure: Anterior colporraphy

Arm B

EXPERIMENTAL

Procedure: vaginal patch plastron

Interventions

Anterior colporraphy PROCEDURE

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.

Arm A

vaginal patch plastron PROCEDURE

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 B

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (9)

CHU de Bordeaux

Bordeaux, 33000, France

RECRUITING

CH de Brive

Brive-la-Gaillarde, 19100, France

RECRUITING

CHU de Clermont Ferrand

Clermont-Ferrand, 63100, France

RECRUITING

CH de Gueret

Guéret, 23000, France

RECRUITING

CHU de Limoges

Limoges, 87000, France

RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42000, France

RECRUITING

CHU de Toulouse - Paule de Viguier

Toulouse, 31059, France

RECRUITING

CHU de Toulouse - Rangueil

Toulouse, 31400, France

RECRUITING

CH de Tulle

Tulle, 19000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 32641096 DERIVED

MeSH Terms

Conditions

Uterine Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: September 27, 2019
• Primary Completion: September 27, 2025
• Study Completion (Estimated): March 27, 2028
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)