VAMP-A: Efficacy Study of Vaginal Mesh for Anterior Prolapse

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00557882
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Duration (Months): 53
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Prolapse; Uterine Prolapse; Cystocele; Pelvic Organ Prolapse	Device: synthetic polypropylene mesh	Phase 4

Detailed Description

Multiple vaginal, abdominal and laparoscopic procedures have been described for surgical correction of pelvic support problems. However, conventional pelvic reconstructive surgeries have been associated with a 20-30% prolapse recurrence rate. The anterior vaginal wall is the site most often recognized as the area of vaginal prolapse recurrence. Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction in an attempt to improve surgical cure rates. Unfortunately, safety and efficacy data have lagged behind the technical advancements.

This trial will randomize women with advanced anterior wall prolapse to two treatment arms:

vaginal reconstructive surgery with mesh and vaginal reconstructive surgery without mesh. The primary outcome is cure of anterior wall prolapse at one year. Secondary outcomes are cure of apical and posterior wall prolapse, quality-of-life measures and complication rates. Patients will be approached for recruitment only after they have made the decision to undergo vaginal surgery for anterior prolapse. The patient and examiner will be blinded to the surgical treatment assignment. Interim measurement of primary and secondary outcomes will be conducted three months post-operatively. Additional follow-up will be conducted at one-year intervals subsequent to the expected one-year endpoint.

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial of Vaginal Mesh for Anterior Prolapse
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: mesh Vaginal reconstructive surgery with synthetic polypropylene mesh	Device: 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.
Active Comparator: no mesh Vaginal reconstructive surgery without mesh	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. women age > 21

2. diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery

3. available for 12 months of follow-up

4. able to complete study questionnaires and assessments.

5. available for 12 months follow-up

Exclusion Criteria:

1. Uterus in place.

2. No anterior vaginal prolapse.

3. Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system.

4. Current intermittent self catheterization.

5. Pregnancy or desire for future fertility.

6. Presence of an adnexal or ovarian mass.

7. Shortened vagina.

8. Other laparoscopic or abdominal/pelvic surgery in the past 3 months.*

9. Known neurologic or medical condition affecting bladder function, e.g. multiple sclerosis, spinal cord injury.

10. Need for surgery requiring an abdominal incision.

11. <12 months post-partum. (Enrollment can be deferred until time requirement has been met).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wahington Hospital Center	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

• Medstar Health Research Institute

Investigators

• Principal Investigator: Andrew I Sokol, MD, Medstar Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click clinical trials for more information about this study " A Randomized Clinical trial of Vaginal Mesh for Prolapse"

Publications

None provided.

• Responsible Party: Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT00557882
• Other Study ID Numbers: 2006-336
• First Posted: Nov 14, 2007
• Last Update Posted: Oct 30, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Medstar Health Research Institute: prolapse; uterus; mesh; bladder
• Additional relevant MeSH terms: Cystocele; Uterine Prolapse; Prolapse; Pelvic Organ Prolapse

Study Results

Participant Flow

Arm/Group Title	Mesh	no Mesh
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	32	33
COMPLETED	27	33
NOT COMPLETED	5	0

Baseline Characteristics

Arm/Group Title	Mesh	no Mesh	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	32	33	65
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	32 100%	33 100%	65 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.4 (10.8)	63.5 (8.9)	63.94 (9.89)
Sex: Female, Male (Count of Participants)
Female	32 100%	33 100%	65 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 9.4%	3 9.1%	6 9.2%
Not Hispanic or Latino	29 90.6%	29 87.9%	58 89.2%
Unknown or Not Reported	0 0%	1 3%	1 1.5%

Outcome Measures

1. Primary Outcome

Title	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Mesh	no Mesh
Arm/Group Description	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.	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.
Measure Participants	32	33
Count of Participants [Participants]	12 37.5%	10 30.3%

Adverse Events

Arm/Group Title	Mesh		no Mesh
Arm/Group Description	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.		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.
All Cause Mortality
	Mesh		no Mesh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/32 (3.1%)		1/33 (3%)
Serious Adverse Events
	Mesh		no Mesh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/32 (15.6%)		0/33 (0%)
Injury, poisoning and procedural complications
mesh erosion	5/32 (15.6%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Mesh		no Mesh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/32 (12.5%)		1/33 (3%)
General disorders
Febrile Illness	1/32 (3.1%)		1/33 (3%)
Postoperative blood transfusion	1/32 (3.1%)		0/33 (0%)
Renal and urinary disorders
cystotomy	2/32 (6.3%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.