Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487328
Recruitment Status : Completed
First Posted : April 4, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.

Condition or disease Intervention/treatment Phase
Uterovaginal and Vaginal Vault Prolapse Procedure: Sacrospinous-Sacrotuberous fixation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse: A Randomized Controlled Trial
Actual Study Start Date : March 21, 2018
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Modified technique for Sacrospinous-Sacrotuberous Fixation
Modified technique for Sacrospinous-Sacrotuberous Fixation
 Procedure: Sacrospinous-Sacrotuberous fixation
Sacrospinous-Sacrotuberous fixation
Active Comparator: Conventional technique for Sacrospinous-Sacrotuberous Fixation
Modified technique for Sacrospinous-Sacrotuberous Fixation
 Procedure: Sacrospinous-Sacrotuberous fixation
Sacrospinous-Sacrotuberous fixation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with recurrence of uterovaginal and vaginal vault prolapse [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. blood loss [ Time Frame: intraoperative ]
  2. Injury to surrounding structures [ Time Frame: intraoperative ]
    Number of participants that experience injury of important surrounding structure intraoperative

  3. operative time [ Time Frame: intraoperative ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age from 40 to 60 years.
  2. POP Q stage III & IV
  3. Uterovaginal prolapse.
  4. Vaginal vault prolapse.
  5. BMI >35.

Exclusion Criteria:

  1. Age > 40 years or < 60 years.
  2. POP Q stage I or II.
  3. BMI < 35.
  4. Previous repair of uterovaginal or vaginal vault prolapse.
  5. Comorbidity with Stress Urinary Incontinence.
  6. Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions.
  7. Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03487328


Locations
Layout table for location information
Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Mohamed S Sweed, MD, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03487328    
Other Study ID Numbers: AS1729
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed S Sweed, MD, Ain Shams University:
treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical