Improving Women's Function After Pelvic Radiation

NCT04544735 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-06

No results posted yet for this study

Summary

The purpose of the study is to develop and test an intervention combining physical therapy (PT) and coping skills training to improve women's sexual function after pelvic radiation.

Conditions

  • Sexual Dysfunction
  • Pelvic Floor Disorders
  • Gynecologic Cancer

Interventions

BEHAVIORAL

Integrated Physical Therapy and Coping Skills Training

The proposed intervention will provide pelvic health physical therapy interventions including: education about vaginal moisturizers and lubricants, low back and hip assessment and instruction in accommodations (e.g., strategies for accommodating sexual position of choice), instruction in vulvar massage, instruction and facilitation of vaginal dilator use, and pelvic floor muscle training (PFMT) and exercises. Women will be given a set of vaginal dilators. Cognitive behavioral techniques that have been successfully used by physical therapists in prior intervention studies will be integrated into the PT intervention including breathing and relaxation techniques, guided imagery, systematic desensitization, cognitive restructuring techniques and coping thoughts, and problem solving

Sponsors & Collaborators

Principal Investigators

  • Rebecca Shelby, PhD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04544735 on ClinicalTrials.gov