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Four-arm Mesh for Vaginal Stump Prolapse

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ClinicalTrials.gov Identifier: NCT03809806
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Paweł Miotła, Medical University of Lublin

Brief 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).

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Sexual Function Abnormal Procedure: 4-arm polypropylene mesh surgery Diagnostic Test: The Female Sexual Function Index (FSFI) questionnaire Diagnostic Test: King Health Questionnaire (KHQ) Diagnostic Test: Pelvic Organ Prolapse Quantification (POPQ) staging Diagnostic Test: Postoperative questionnaire Diagnostic Test: The Short Form Health Survey (SF 36) questionnaire Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with vaginal stump prolapse who had undergone hysterectomy in the past
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
patients after hysterectomy
modified anterior transvaginal mesh surgery
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • malignant diseases
  • unability to understand informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809806


Locations
Poland
2nd Gynecology Department
Lublin, Poland, 20-954
Sponsors and Collaborators
Medical University of Lublin
Investigators
Principal Investigator: Tomasz Rechberger, Professor 2nd Gynecology Department Medical University in Lublin

Responsible Party: Paweł Miotła, Clinical Professor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03809806     History of Changes
Other Study ID Numbers: 02/2019
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paweł Miotła, Medical University of Lublin:
vaginal stump prolapse
sexual function
quality of life

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical