Trial Outcomes & Findings for Efficacy Study of Vaginal Mesh for Anterior Prolapse (NCT NCT00557882)

NCT ID: NCT00557882

Last Updated: 2020-10-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 65 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2020-10-30

Participant Flow

Participant milestones

Measure	Mesh Vaginal reconstructive surgery with synthetic polypropylene mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.	no Mesh Vaginal reconstructive surgery without mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
Overall Study STARTED	32	33
Overall Study COMPLETED	27	33
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Vaginal Mesh for Anterior Prolapse

Baseline characteristics by cohort

Measure	Mesh n=32 Participants Vaginal reconstructive surgery with synthetic polypropylene mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.	no Mesh n=33 Participants Vaginal reconstructive surgery without mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	64.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	63.5 years STANDARD_DEVIATION 8.9 • n=7 Participants	63.94 years STANDARD_DEVIATION 9.89 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: NIH optimal prolapse cure (Pelvic Organ Prolapse Quantifications System (POP-Q) stage \<1)

Outcome measures

Measure	Mesh n=32 Participants Vaginal reconstructive surgery with synthetic polypropylene mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.	no Mesh n=33 Participants Vaginal reconstructive surgery without mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
The Primary Outcome Measure for Objective Treatment Success is Anterior Prolapse, Point Ba at Stage 0 or 1 (Defined as Maximal Descent of the Anterior Wall to Greater Than 1 cm Above the Hymen) at One Year.	12 Participants	10 Participants

Adverse Events

Mesh

Serious events: 5 serious events

Other events: 4 other events

Deaths: 1 deaths

no Mesh

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	Mesh n=32 participants at risk Vaginal reconstructive surgery with synthetic polypropylene mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.	no Mesh n=33 participants at risk Vaginal reconstructive surgery without mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
Injury, poisoning and procedural complications mesh erosion	15.6% 5/32	0.00% 0/33

Other adverse events

Measure	Mesh n=32 participants at risk Vaginal reconstructive surgery with synthetic polypropylene mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.	no Mesh n=33 participants at risk Vaginal reconstructive surgery without mesh synthetic polypropylene mesh: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
Renal and urinary disorders cystotomy	6.2% 2/32	0.00% 0/33
General disorders Febrile Illness	3.1% 1/32	3.0% 1/33
General disorders Postoperative blood transfusion	3.1% 1/32	0.00% 0/33

Additional Information

Andrew Sokol, MD

MedStar Washington Hospital Center

Phone: 2028776526

Email: andrew.i.sokol@medstar.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place