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Radiofrequency Combined with Cognitive-Behavioral Therapy for Female Genito-Pelvic Pain/Penetration Disorder: A Pilot Study

Efficacy of Pelvic Floor Radiofrequency Therapy Combined with Sexual Cognitive-Behavioral Therapy for Genito-Pelvic Pain/Penetration Disorder: A Prospective, Single-Arm, Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128785
Enrollment
Unknown
Registered
2026-07-26
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Genito-Pelvic Pain/Penetration Disorder (GPPPD)

Interventions

Treatment Group:Pelvic floor radiofrequency therapy combined with sexual cognitive-behavioral therapy

Sponsors

Obstetris & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–45 years, with willingness to attempt sexual intercourse and having a partner with normal erectile function; 2. Meeting the DSM-5 diagnostic criteria for GPPPD and having symptoms persisting for at least 6 months; 3. Having a Visual Analog Scale (VAS) score for insertion- or intercourse-related pain of >= 4 on a 0–10 scale; 4. Having a Female Sexual Function Index (FSFI) total score of <= 26.55 or a pain domain score of <= 4; 5. Voluntary participation in the study and written informed consent.

Exclusion criteria

Exclusion criteria: 1. Having a definite organic pathology (such as acute pelvic inflammatory disease or congenital vaginal anatomical abnormalities); 2. Currently pregnant, breastfeeding, or planning to become pregnant within the next 3 months; 3. Severe comorbid psychiatric disorders (such as major depressive disorder or schizophrenia) or cognitive impairment; 4. History of pelvic floor radiofrequency therapy or systematic cognitive-behavioral therapy (CBT) within the past 3 months; 5. Having undergone pelvic surgery within the past 6 months or having a metallic intrauterine device (IUD) in situ; 6. Having other severe chronic pain syndromes or neurological disorders.

Design outcomes

Primary

MeasureTime frame
Pre- to post-treatment change in FSFI pain domain score;—

Secondary

MeasureTime frame
central sensitization inventory-9, CSI-9;Generalized Anxiety Disorder-7,GAD-7;Pain severity (VAS score for pain during intercourse or insertion of a No. 5 dilator);Sexual Satisfaction Questionnaire;Penetration ability (Lamont-Pacik classification);—

Countries

China

Contacts

Public ContactYisong Chen

Obstetris & Gynecology Hospital of Fudan University

cys373900207@aliyun.com+86 21 33189900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026