Cystocele, Pelvic Organ Prolapse, Rectocele, Uterine Prolapse, Vaginal Prolapse
Conditions
Keywords
prolapse, uterus, pelvic organ, vaginal prolpase
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 pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
Detailed description
Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the technical advancements. No randomized controlled trials of different vaginal apical suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal Stage II-IV prolapse.
Interventions
DEVICEsynthetic monofilament polypropylene mesh
Vaginal prolapse repair with mesh
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
* Woman \> 21 yrs * Stage II-IV vaginal prolapse * Desires vaginal reconstructive surgery * Able to complete study questionnaires and assessments * Uterus \< 12 weeks size * Available for 12 months follow-up
Exclusion criteria
* 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. * Current intermittent catheterization. * Pregnancy or desire for future fertility. * Presence of an adnexal mass. * Shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys). * Other laparoscopic or abdominal/pelvic surgery in the past 3 months. * Known neurologic or medical condition affecting bladder function, e.g. Multiple Sclerosis, spinal cord injury. * Need for concomitant surgery requiring an abdominal incision. * \< 12 months post-partum. * Non-english speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anatomic Cure at 3 Years | 3 year | 3 different measures for Anatomic cure using POPQ measurements: 1. POP-Q at Stage I or less\* (POP-Q points Ba, Bp or C -1 or less); 2. no prolapse beyond the hymen (Ba, Bp or C 0 or less); 3. no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no. Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bothersome Dyspareunia | 3 year | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia |
Countries
United States
Participant flow
Recruitment details
From January 3, 2007 to August 1, 2009, 238 women were identified as eligible and 65 randomized (32 to experimental group (mesh) and 33 to control group (non-mesh)). All patients completed 3 month followup. Study recruitment halted at median followup of 9.7 months due to pre-determined criteria of vaginal mesh exposure in 5/32 patients (15.6%) in the mesh arm.
Participants by arm
| Arm | Count |
|---|---|
| Prolift Mesh vaginal prolapse repair with anterior or total mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh | 25 |
| Prolapse Repair Without Mesh vaginal prolapse repair without mesh (native tissue repair) | 26 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 36 Months | Censored due to reoperation | 3 | 0 |
| 36 Months | Death | 1 | 2 |
| 36 Months | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | Total | Prolift Mesh | Prolapse Repair Without Mesh |
|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 9.8 | 62.6 years STANDARD_DEVIATION 10.6 | 63.1 years STANDARD_DEVIATION 9 |
| BMI | 27.9 kg/m^2 STANDARD_DEVIATION 6 | 27.6 kg/m^2 STANDARD_DEVIATION 5.5 | 28.2 kg/m^2 STANDARD_DEVIATION 6.4 |
| education college or graduate | 38 Participants | 21 Participants | 17 Participants |
| education completed high school | 12 Participants | 4 Participants | 8 Participants |
| education High school or less | 1 Participants | 0 Participants | 1 Participants |
| hysterectomy | 18 Participants | 9 Participants | 9 Participants |
| insurance medicare | 27 Participants | 13 Participants | 14 Participants |
| insurance Private | 24 Participants | 12 Participants | 12 Participants |
| married | 35 Participants | 16 Participants | 19 Participants |
| Parity | 2 number deliveries | 2 number deliveries | 2 number deliveries |
| POP-Q stage stage 2 | 11 Participants | 7 Participants | 4 Participants |
| POP-Q stage stage 3 | 34 Participants | 16 Participants | 18 Participants |
| POP-Q stage stage 4 | 6 Participants | 2 Participants | 4 Participants |
| Postmenopausal | 47 Participants | 23 Participants | 24 Participants |
| prior incontinence surgery | 3 Participants | 2 Participants | 1 Participants |
| prior prolapse surgery | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized African American | 13 Participants | 6 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 33 Participants | 16 Participants | 17 Participants |
| Sex: Female, Male Female | 51 Participants | 25 Participants | 26 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 | 2 / 33 |
| other Total, other adverse events | 0 / 32 | 5 / 33 |
| serious Total, serious adverse events | 5 / 32 | 0 / 33 |
Outcome results
Primary
Number of Participants With Anatomic Cure at 3 Years
3 different measures for Anatomic cure using POPQ measurements: 1. POP-Q at Stage I or less\* (POP-Q points Ba, Bp or C -1 or less); 2. no prolapse beyond the hymen (Ba, Bp or C 0 or less); 3. no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no. Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better
Time frame: 3 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prolift Mesh | Number of Participants With Anatomic Cure at 3 Years | no reoperation/retreatment | 20 Participants |
| Prolift Mesh | Number of Participants With Anatomic Cure at 3 Years | composite stage less than/equal 1, no bulge symptoms, satisfaction very much better or much better | 8 Participants |
| Prolift Mesh | Number of Participants With Anatomic Cure at 3 Years | composite no prolapse beyond hymen, no bulge symptoms, satisfaction very much better or much better | 15 Participants |
| Prolapse Repair Without Mesh | Number of Participants With Anatomic Cure at 3 Years | composite stage less than/equal 1, no bulge symptoms, satisfaction very much better or much better | 8 Participants |
| Prolapse Repair Without Mesh | Number of Participants With Anatomic Cure at 3 Years | composite no prolapse beyond hymen, no bulge symptoms, satisfaction very much better or much better | 12 Participants |
| Prolapse Repair Without Mesh | Number of Participants With Anatomic Cure at 3 Years | no reoperation/retreatment | 21 Participants |
Comparison: Sample size primary outcome 1 year: 45 participants per arm, 20% difference success (70% no mesh and 90% mesh), alpha of .05 and 80% power, 15% loss to follow-up.p-value: <0.05t-test, 2 sided
Secondary
Bothersome Dyspareunia
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia
Time frame: 3 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prolift Mesh | Bothersome Dyspareunia | Persistent dyspareunia | 5 Participants |
| Prolift Mesh | Bothersome Dyspareunia | resolution dyspareunia | 2 Participants |
| Prolift Mesh | Bothersome Dyspareunia | de novo dyspareunia | 2 Participants |
| Prolapse Repair Without Mesh | Bothersome Dyspareunia | Persistent dyspareunia | 5 Participants |
| Prolapse Repair Without Mesh | Bothersome Dyspareunia | resolution dyspareunia | 1 Participants |
| Prolapse Repair Without Mesh | Bothersome Dyspareunia | de novo dyspareunia | 1 Participants |