Trial Outcomes & Findings for Sacro-Spinous Ligaments Anterior Apical Anchoring (NCT NCT01842464)

Results Overview

The change with distance measured by centimeters, between the vaginal apex and the introitus

Recruitment status

COMPLETED

Target enrollment

44 participants

Primary outcome timeframe

One year

Results posted on

2015-06-19

Participant Flow

44 patients with significant Pelvic Organ Prolapse requiring mesh reconstruction during 2011-2012

The study patients were retrieved out of the operated patients population during the study period.

Participant milestones

Participant milestones
Measure	Anterior Sacro-Spinos Support Anterior Sacro-Spinous Support :
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sacro-Spinous Ligaments Anterior Apical Anchoring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anterior Sacro-Spinos Support n=44 Participants Anterior Sacro-Spinous Support :
Age, Categorical <=18 years	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=113 Participants
Age, Categorical >=65 years	9 Participants n=113 Participants
Age, Continuous	62.4 years STANDARD_DEVIATION 7.75 • n=113 Participants
Sex: Female, Male Female	44 Participants n=113 Participants
Sex: Female, Male Male	0 Participants n=113 Participants

PRIMARY outcome

Timeframe: One year

The change with distance measured by centimeters, between the vaginal apex and the introitus

Outcome measures

Outcome measures
Measure	Anterior Sacro-Spinous Support n=44 Participants Number of participants with successful Sacro-Spinous Ligaments Anterior Apical Anchoring
The Change With Distance Between the Vaginal Apex and the Introitus	-4.4 centimeters Interval -7.0 to 7.0

PRIMARY outcome

Timeframe: one year

Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.

Outcome measures

Outcome measures
Measure	Anterior Sacro-Spinous Support n=44 Participants Number of participants with successful Sacro-Spinous Ligaments Anterior Apical Anchoring
Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring	44 participants

PRIMARY outcome

Timeframe: one year

Population: occurrence and severity of complication is recorded

Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.

Outcome measures

Outcome measures
Measure	Anterior Sacro-Spinous Support n=44 Participants Number of participants with successful Sacro-Spinous Ligaments Anterior Apical Anchoring
Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure	0 participants

Adverse Events

Anterior Sacro-Spinos Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Menahem Neuman

Western Galilee MC

Phone: +972546444033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place