Pelvic Organ ProlapseNCT07517965
Vaginal Vault Native Tissue Suspension
A study testing Mackenrodt uterosacral double ligaments suspension in people with Pelvic Organ Prolapse, run by Assiut University at 1 site in Egypt.
Trial summary
Vaginal vault suspension at time of abdominal hysterectomy using Mackenrodt and uterosacral ligaments. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Mackenrodt uterosacral double ligaments suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women undergoing hysterectomy
- Stage 1 or more pelvic organ prolapse
Who cannot join
- pregnacy or 6 months postpartum
- previous suspension surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Women's Health Hospital
Asyut
Women Hospital, 0882414916, ethics_committee12@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Mackenrodt uterosacral double ligaments suspension
- Keywords
- Vault Suspension, Mackenrodt ligaments, Uterosacral ligaments
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mackenrodt uterosacral double ligaments suspensionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Suspension group | Experimental | Not described Receives: Procedure: Mackenrodt uterosacral double ligaments suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic organ prolapse Stage
Increase stage means bad outcome Minimum: 0 , Maximum:4
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start3 Jun 2026
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal M.fekry, Assiut University
- Investigators
- Women H Hospital, Principal investigator, Women's health hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517965
- Sponsor's protocol ID
- MUS
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Mackenrodt Uterosacral Double Ligaments Vault Suspension for Treatment of Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT07517965
- Acronym / sponsor ID
- MUS
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Vault Suspension, Mackenrodt ligaments, Uterosacral ligaments
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaginal vault suspension at time of abdominal hysterectomy using Mackenrodt and uterosacral ligaments.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspension group | Experimental | Procedure: Mackenrodt uterosacral double ligaments suspension |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- women undergoing hysterectomy
- Stage 1 or more pelvic organ prolapse
Key exclusion criteria (2 listed)
- pregnacy or 6 months postpartum
- previous suspension surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mackenrodt uterosacral double ligaments suspensionTotal 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 | Procedure or surgery | Suspension group |
Primary outcome
Pelvic organ prolapse Stage
Time frame: 3 months
Increase stage means bad outcome Minimum: 0 , Maximum:4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Women H Hospital principal investigator
Women's health hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mackenrodt uterosacral double ligaments suspension in people with Pelvic Organ Prolapse, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Gamal (+20882312388, mohamedbeethoven2040@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic organ prolapse Stage (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.