NCT03809806

Four-arm Mesh for Vaginal Stump Prolapse

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Medical University of Lublin · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Pelvic Organ Prolapse
• Sexual Function Abnormal

Interventions

Type	Name	Description
PROCEDURE	4-arm polypropylene mesh surgery	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.
DIAGNOSTIC_TEST	The Female Sexual Function Index (FSFI) questionnaire	patients fulfilled questionnaire before and 1 year after procedure
DIAGNOSTIC_TEST	King Health Questionnaire (KHQ)	patients fulfilled questionnaire before and 1 year after procedure
DIAGNOSTIC_TEST	Pelvic Organ Prolapse Quantification (POPQ) staging	Pelvic Organ Prolapse staging before and 1 year after the procedure
DIAGNOSTIC_TEST	Postoperative questionnaire	Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure
DIAGNOSTIC_TEST	The Short Form Health Survey (SF 36) questionnaire	patients fulfilled questionnaire before and 1 year after procedure

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2019-01-18
• Last updated: 2019-01-18

Locations

1 site across 1 country: Poland