Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
Conditions
Keywords
prasterone, estriol, vaginal therapy
Brief summary
This prospective, non-randomized comparative study evaluated the effects of short-term vaginal treatment with prasterone or estriol in women with pelvic floor disorders who were awaiting urogynecological surgery. A total of 74 women were included, with 37 participants receiving vaginal prasterone and 37 receiving vaginal estriol. Treatment was administered before surgery for approximately 8 weeks. The study assessed changes in pelvic floor symptoms and quality of life using the WHOQOL-BREF questionnaire and symptom severity scales. The aim was to compare the effects of the two vaginal treatments on symptoms and quality of life before urogynecological surgery.
Detailed description
Women with pelvic floor disorders, including pelvic organ prolapse and/or stress urinary incontinence, who were scheduled for urogynecological surgery were prospectively enrolled. Participants received preoperative vaginal treatment with either prasterone or estriol according to the treatment protocol used at the study center. The study was non-randomized. Quality of life was evaluated using the WHOQOL-BREF questionnaire, and pelvic floor symptoms were assessed using symptom severity scales before and after treatment. The primary objective was to evaluate changes in quality of life and pelvic floor symptoms and to compare outcomes between the prasterone and estriol groups.
Interventions
DRUGEstriol
Vaginal estriol (Oekolp forte) was administered once daily for 14 days, followed by twice-weekly administration for 8 weeks before urogynecological surgery. In participants with advanced pelvic organ prolapse, estriol cream was used when clinically indicated.
6.5 mg vaginally once daily for 8 weeks before urogynecological surgery.
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were assigned to one of two parallel treatment groups receiving vaginal prasterone or vaginal estriol before urogynecological surgery.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women aged 18 years or older. * Clinically diagnosed pelvic organ prolapse, POP-Q stage II-IV, or stress urinary incontinence, Stamey grade 2-3. * Scheduled for urogynecological surgery. * Received preoperative vaginal treatment with either prasterone or estriol. * Availability of baseline and post-treatment clinical data. * Completed quality-of-life questionnaires.
Exclusion criteria
* Concomitant pelvic organ prolapse and stress urinary incontinence. * Incomplete treatment course. * Missing baseline or post-treatment clinical data. * Incomplete quality-of-life questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Measured by WHOQOL-BREF | Baseline to 8 weeks | Quality of life was assessed using the World Health Organization Quality of Life - BREF (WHOQOL-BREF) questionnaire at baseline and after 8 weeks of vaginal treatment. The questionnaire evaluates four domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. Changes from baseline were compared between the prasterone and estriol groups. |
Countries
Poland
Outcome results
None listed