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Completed

NCT Number: NCT03809806

Four-arm Mesh for Vaginal Stump Prolapse

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).

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Key information

Conditions

Pelvic Organ Prolapse Genital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Sexual Dysfunction, Physiological Sexual Function Abnormal Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

2nd Gynecology Department

Lublin, 20-954, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • malignant diseases
  • unability to understand informed consent

Treatment and study plan

4-arm polypropylene mesh surgery

Procedure

Pelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments.

The Female Sexual Function Index (FSFI) questionnaire

Diagnostic Test

patients fulfilled questionnaire before and 1 year after procedure

King Health Questionnaire (KHQ)

Diagnostic Test

patients fulfilled questionnaire before and 1 year after procedure

Pelvic Organ Prolapse Quantification (POPQ) staging

Diagnostic Test

Pelvic Organ Prolapse staging before and 1 year after the procedure

Postoperative questionnaire

Diagnostic Test

Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure

The Short Form Health Survey (SF 36) questionnaire

Diagnostic Test

patients fulfilled questionnaire before and 1 year after procedure

Primary outcomes

  1. Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure

    Time frame: 1 year

    assessment of POPQ 1 year after mesh operation, Pelvic Organ Prolapse Quantification system (POP-Q) refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women. It provides a standardized tool for documenting, comparing, and communicating clinical findings with proven interobserver and intraobserver reliability

Secondary outcomes

  1. Sexual function 1 year after procedure

    Time frame: 1 year

    assessment of sexual function before and 1 year after the procedure with the use of The Female Sexual Function Index questionnaire

  2. Urinary incontinence 1 year after procedure

    Time frame: 1 year

    assessment of urinary incontinence before and 1 year after the procedure with the use of the Urogenital Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7) questionnaire

  3. quality of life 1 year after procedure

    Time frame: 1 year

    assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36)

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2019
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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