Cystocele, Pelvic Organ Prolapse, Uterine Prolapse, Vaginal Prolapse
Conditions
Keywords
prolapse, uterus, mesh, bladder
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.
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.
Interventions
DEVICEsynthetic 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.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 33 |
| Total | 65 |
Baseline characteristics
| Characteristic | Mesh | no Mesh | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 33 Participants | 65 Participants |
| Age, Continuous | 64.4 years STANDARD_DEVIATION 10.8 | 63.5 years STANDARD_DEVIATION 8.9 | 63.94 years STANDARD_DEVIATION 9.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 29 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 32 Participants | 33 Participants | 65 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 32 | 1 / 33 |
| other Total, other adverse events | 4 / 32 | 1 / 33 |
| serious Total, serious adverse events | 5 / 32 | 0 / 33 |
Outcome results
Primary
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
Population: NIH optimal prolapse cure (Pelvic Organ Prolapse Quantifications System (POP-Q) stage \<1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh | 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 |
| no Mesh | 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. | 10 Participants |