Vaginal Vault Native Tissue Suspension

June 3, 2026 updated by: Mohamed Gamal M.fekry, Assiut University

Efficacy of a Novel Mackenrodt Uterosacral Double Ligaments Vault Suspension for Treatment of Pelvic Organ Prolapse

Vaginal vault suspension at time of abdominal hysterectomy using Mackenrodt and uterosacral ligaments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hysterectomy is one of the most frequently performed gynecological procedures. Hysterectomy remains an important treatment option for a number of benign and malignant indication. Several other studies have shown that hysterectomy independently increased the incidence of subsequent POP, especially when hysterectomy was performed for POP indication. Some studies even have shown that women after hysterectomy were 50% more likely to report symptoms of pelvic floor disorders. With regard to prolapse of the vaginal apex in particular, it has been hypothesized that the "disruption of the cardinaluterosacral ligament complex" during hysterectomy decreases vaginal support. Therefore, adequate support for the vaginal apex would be an essential component to reduce the incidence of post-hysterectomy apical POP. Our study aims to evaluate novel Mackenrodt Uterosacral double ligament vault suspension technique as a treatment option for pelvic prolapse during total abdominal hysterectomy.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • women undergoing hysterectomy
  • Stage 1 or more pelvic organ prolapse

Exclusion Criteria:

  • pregnacy or 6 months postpartum
  • previous suspension surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suspension group
Procedure: Mackenrodt uterosacral double ligaments suspension
Total hysterectomy will be performed and vaginal vault will be closed with absorbable vicryl sutures The pelvis is then inspected and both uterosacral ligaments and ureters are identified. The proximal part of the mid-portion of each ligament is grasped and put under tension. In case of proximity to the ureter, a peritoneal release incision is performed to avoid kinking of the ipsilateral ureter. A Vicryl 1/0 suture is then used and passed through the proximal portion of the ligament approximately 1 cm distal to its sacral origin, in order to avoid entrapment of S3 nerve root. The suture is then passed through the mid portion of the ligament in one or two bites and secured to the posterior vaginal wall.hese steps are repeated in the contralateral ligament. Manchester procedure: Vicryl 1 suture will pass through Mackenrodt ligament and then fixed to the anterior vaginal wall. The suture is repeated on the opposite side ,so both Mackenrodt ligaments will be fixed th anterior vagina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic organ prolapse Stage
Time Frame: 3 months
Increase stage means bad outcome Minimum: 0 , Maximum:4
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Women H Hospital, Women's Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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