NCT03809806 - Four-arm Mesh for Vaginal Stump Prolapse | Biotech Hunter

Enrollment

180

Participants

Timeline

Start Date

January 1, 2014

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions

Pelvic Organ ProlapseSexual Function Abnormal

Interventions

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

Trial Locations (1)

20-954

2nd Gynecology Department, Lublin

All Listed Sponsors

lead

Medical University of Lublin

OTHER