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出境医 / 临床实验 / Four-arm Mesh for Vaginal Stump Prolapse

Four-arm Mesh for Vaginal Stump Prolapse

Study Description
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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: N/A
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
Arms and Interventions
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
Outcome Measures
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)


Eligibility Criteria
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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
Contacts and Locations

Locations
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Poland
2nd Gynecology Department
Lublin, Poland, 20-954
Sponsors and Collaborators
Medical University of Lublin
Investigators
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Principal Investigator: Tomasz Rechberger, Professor 2nd Gynecology Department Medical University in Lublin
Tracking Information
First Submitted Date  ICMJE January 16, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE January 1, 2014
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Four-arm Mesh for Vaginal Stump Prolapse
Official Title  ICMJE Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Pelvic Organ Prolapse
  • Sexual Function Abnormal
Intervention  ICMJE
  • 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
Study Arms  ICMJE patients after hysterectomy
modified anterior transvaginal mesh surgery
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019) 		180
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • malignant diseases
  • unability to understand informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809806
Other Study ID Numbers  ICMJE 02/2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paweł Miotła, Medical University of Lublin
Study Sponsor  ICMJE Medical University of Lublin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tomasz Rechberger, Professor 2nd Gynecology Department Medical University in Lublin
PRS Account Medical University of Lublin
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP