Pelvic Organ Prolapse, Sexual Function Abnormal
Conditions
Keywords
vaginal stump prolapse, sexual function, quality of life
Brief summary
To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification \[POP-Q\] system staging).
Detailed description
Pelvic reconstructive procedures were primarily performed using the transvaginal four arm polypropylene mesh, which was inserted through: upper arms- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent hysterectomy in the past apart from one which underwent vaginal hysterectomy during the procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective evaluations included Pelvic Organ Prolapse Quantification \[POP-Q\] staging, preoperative and 1-year postoperative questionnaires were performed.
Interventions
PROCEDURE4-arm polypropylene mesh surgery
Pelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments.
DIAGNOSTIC_TESTThe Female Sexual Function Index (FSFI) questionnaire
patients fulfilled questionnaire before and 1 year after procedure
DIAGNOSTIC_TESTKing Health Questionnaire (KHQ)
patients fulfilled questionnaire before and 1 year after procedure
DIAGNOSTIC_TESTPelvic Organ Prolapse Quantification (POPQ) staging
Pelvic Organ Prolapse staging before and 1 year after the procedure
DIAGNOSTIC_TESTPostoperative questionnaire
Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure
DIAGNOSTIC_TESTThe Short Form Health Survey (SF 36) questionnaire
patients fulfilled questionnaire before and 1 year after procedure
Sponsors
Medical University of Lublin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with vaginal stump prolapse who had undergone hysterectomy in the past
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy
Exclusion criteria
* malignant diseases * unability to understand informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure | 1 year | assessment of POPQ 1 year after mesh operation, Pelvic Organ Prolapse Quantification system (POP-Q) refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women. It provides a standardized tool for documenting, comparing, and communicating clinical findings with proven interobserver and intraobserver reliability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual function 1 year after procedure | 1 year | assessment of sexual function before and 1 year after the procedure with the use of The Female Sexual Function Index questionnaire |
| Urinary incontinence 1 year after procedure | 1 year | assessment of urinary incontinence before and 1 year after the procedure with the use of the Urogenital Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7) questionnaire |
| quality of life 1 year after procedure | 1 year | assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36) |
Countries
Poland
Outcome results
None listed