Four-arm Mesh for Vaginal Stump Prolapse

Medical University of Lublin

Status: Completed

Conditions: Sexual Function Abnormal; Pelvic Organ Prolapse

Treatments: Procedure: 4-arm polypropylene mesh surgery; Diagnostic Test: King Health Questionnaire (KHQ); Diagnostic Test: Postoperative questionnaire; Diagnostic Test: The Short Form Health Survey (SF 36) questionnaire; Diagnostic Test: Pelvic Organ Prolapse Quantification (POPQ) staging; Diagnostic Test: The Female Sexual Function Index (FSFI) questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT03809806

02/2019

Details and patient eligibility

About

To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification [POP-Q] system staging).

Full description

Pelvic reconstructive procedures were primarily performed using the transvaginal four arm polypropylene mesh, which was inserted through: upper arms- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent hysterectomy in the past apart from one which underwent vaginal hysterectomy during the procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective evaluations included Pelvic Organ Prolapse Quantification [POP-Q] staging, preoperative and 1-year postoperative questionnaires were performed.

Enrollment: 180 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy

Exclusion criteria

• malignant diseases
• unability to understand informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

patients after hysterectomy

Other group

Description:

modified anterior transvaginal mesh surgery

Treatment:

Procedure: 4-arm polypropylene mesh surgery

Diagnostic Test: King Health Questionnaire (KHQ)

Diagnostic Test: The Short Form Health Survey (SF 36) questionnaire

Diagnostic Test: Postoperative questionnaire

Diagnostic Test: Pelvic Organ Prolapse Quantification (POPQ) staging

Diagnostic Test: The Female Sexual Function Index (FSFI) questionnaire