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NCT03809806 Clinical Trial

Four-arm Mesh for Vaginal Stump Prolapse

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03809806
Other study ID # 02/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2014
Est. completion date December 31, 2017

Study information
Verified date January 2019
Source Medical University of Lublin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- malignant diseases

- unability to understand informed consent

Study Design

Related Conditions & MeSH terms

Intervention

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
• King Health Questionnaire (KHQ)
patients fulfilled questionnaire before and 1 year after procedure
• Pelvic Organ Prolapse Quantification (POPQ) staging
Pelvic Organ Prolapse staging before and 1 year after the procedure
• Postoperative questionnaire
Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure
• The Short Form Health Survey (SF 36) questionnaire
patients fulfilled questionnaire before and 1 year after procedure

Locations
Country Name City State
Poland 2nd Gynecology Department Lublin

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure 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 1 year
Secondary Sexual function 1 year after procedure assessment of sexual function before and 1 year after the procedure with the use of The Female Sexual Function Index questionnaire 1 year
Secondary Urinary incontinence 1 year after procedure 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 1 year
Secondary quality of life 1 year after procedure assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36) 1 year
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Active, not recruiting NCT05420831 - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment N/A
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Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A