Pelvinity: Real World Effectiveness study | CE-marked Medical Device | Pregnancy, Prolapse and Pelvic Congestion

Pelvinity — Clinical Data & Professional Information

CE-marked medical device. Backed by real-world data.

Your referrals reflect your clinical judgment. That's why Pelvinity was designed to meet a clinical standard - not just a commercial one.

Pelvinity is a vulvo-pelvic compression medical device designed to reduce pelvic pain, pressure, and heaviness in women experiencing vulvo-pelvic varicosities during pregnancy, urogenital prolapse, and pelvic congestion syndrome.

This is not an accessory. It is a CE-marked, class I medical device, manufactured in France, and subject to the requirements of EU Medical Device Regulation (EU) 2017/745.

Real-World Effectiveness Study

Data collection: April – May 2026

Study report published: June 2026

→ Download the full study report (PDF)

A questionnaire was distributed by email to all Pelvinity customers. It collected: (1) reasons for purchase (multiple selection permitted, with a free-text option); (2) perceived discomfort or heaviness before use on a numerical scale of 0–10; (3) perceived discomfort or heaviness since using Pelvinity on a numerical scale of 0–10; and (4) user age.

518 users who had purchased Pelvinity completed the questionnaire.

Results

⭐ 96.3% of users reported symptom improvement

⭐ Mean discomfort score: 8.3/10 before use → 3.0/10 after use (64% reduction)

⭐ Very large effect size: Cohen's d = 2.13

⭐ Effectiveness demonstrated across all age groups, in women ranging from 19 to 86 years old

⭐ Consistent results across all clinical conditions studied, including combination and chronic conditions

Symptom improvement was greatest in conditions with a vascular etiology. Among the two primary subgroups:

Vulvar varicosities and other pregnancy-related discomfort: 98.4% improvement rate
Chronic and structural conditions (prolapse, PCS, multiple comorbidities including endometriosis, dysmenorrhea, urinary incontinence): 94.3% improvement rate

Methodological note — This is an observational real-world study without a control group. Results reflect user-reported perceived benefit under normal conditions of use. Statistical robustness is strong (Wilcoxon test, W=722, p<0.0001); interpretation should account for the absence of a comparator.

→ Download the full study report (PDF)

Santos-Souffir E, Perrier ET. Effectiveness of the Pelvinity compression garment on pelvic and vulvar discomfort: results from a usage questionnaire. Herapreg, France, 2026.

Clinical Indications

PELVINITY® is indicated to reduce symptoms (pain, pressure, and heaviness) through compression of the lower abdomen combined with compression of the vulvar area.

Intended users

Adult women, including pregnant women, experiencing pressure or heaviness due to conditions including vulvar varicosities, genitourinary prolapse, and pelvic congestion.

Indications for use

Pelvinity is indicated for:

Pelvic and/or vulvar varicosities (during pregnancy)
Pelvic organ prolapse (POP)
Pelvic congestion syndrome

CE Marking & Regulatory Compliance

Pelvinity is a Class I CE-marked medical device, manufactured in France, in conformity with the requirements of EU Medical Device Regulation (EU) 2017/745.

Partner With Us

Pelvinity is manufactured in France using quality materials, developed in collaboration with pelvic health professionals following several years of research.

We welcome enquiries from healthcare professionals wishing to learn more about Pelvinity, its clinical data, to request a demonstration unit, or to discuss integration into clinical practice.