Vaginal Prasterone Versus Estriol in Women With Pelvic Floor Disorders

NCT07854873 | Completed

• 1 other identifier: PRASTERONE-ESTRIOL-2026
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse (POP); Stress Urinary Incontinence (SUI)

Keywords

prasterone; estriol; vaginal therapy

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life Measured by WHOQOL-BREF

  Quality of life was assessed using the 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. Changes from baseline were compared between the prasterone and estriol groups.

  Baseline to 8 weeks

Study Arms (2)

Arm1: Prasterone Group

EXPERIMENTAL

\- Participants received vaginal prasterone 6.5 mg once daily for 8 weeks before urogynecological surgery.

Drug: Prasterone (DHEA)

Arm2: Estriol Group

ACTIVE COMPARATOR

Participants received vaginal estriol according to the preoperative treatment regimen before urogynecological surgery.

Drug: Estriol

Interventions

Prasterone (DHEA) DRUG

6.5 mg vaginally once daily for 8 weeks before urogynecological surgery.

Arm1: Prasterone Group

Estriol DRUG

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.

Arm2: Estriol Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and completed quality-of-life questionnaires.

You may not qualify if:

• Concomitant pelvic organ prolapse and stress urinary incontinence. Incomplete treatment course. Missing baseline or post-treatment clinical data. Incomplete quality-of-life questionnaires.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Gynecology and Obstetrics Clinical Hospital, Poznan University of Medical Sciences

Poznan, Greater Poland Voivodeship, 60-535, Poland

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress

Interventions

Dehydroepiandrosterone; Estriol

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Estrenes; Estranes; Estradiol Congeners

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were assigned to one of two parallel treatment groups receiving vaginal prasterone or vaginal estriol before urogynecological surgery.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2022
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)