Prolapse
Conditions
Keywords
Cystocele, prolapse, anterior repair, colporrhaphy
Brief summary
The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.
Detailed description
It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.
Interventions
PROCEDUREanterior vaginal repair (colporrhaphy)
vaginal repair
PROCEDUREabdominal paravaginal defect repair
abdominal repair
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.
Exclusion criteria
* Patients with at least 2 previous prolapse surgeries * Patients who are pregnant or planning to have a pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery | 4 years | POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported. |
Secondary
| Measure | Time frame |
|---|---|
| The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse. | 4 years |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment were between 2006 and 2010. Patients were recruited from the urogynecology outpatient clinic at Geisinger.
Pre-assignment details
90 patients were screened for eligibility and 70 were recruited. The remaining 20 either declined participation or were not eligible.
Participants by arm
| Arm | Count |
|---|---|
| Anterior Colporrhaphy Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) | 35 |
| Paravaginal Defect Repair Abdominal paravaginal defect repair cystocele (dropped bladder) | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Paravaginal Defect Repair | Anterior Colporrhaphy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 27 Participants | 53 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 13 | 54 years STANDARD_DEVIATION 11 | 54 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 35 participants | 35 participants | 70 participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 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 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.
Time frame: 4 years
Population: Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).
Secondary
The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse.
Time frame: 4 years
Population: Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).