Late Side-effects After Cervical Cancer Treatment - Prevention and Treatment

Summary

Late side-effects following gynecological cancer are predominantly symptoms from the pelvic region originating from the bowels, urinary tract, lymphatic system, genitals and musculoskeletal system. Pelvic floor dysfunctions such as urinary- and anal incontinence, pelvic organ prolapse, vaginal stenosis as well as compromised sexual function and dyspareunia appear to be highly prevalent. The incidence of gynecological cancer in Norway was 1700 in 2020 and the survival rate in Norway is among the highest in the world. Most women with cervical cancers are treated with curative intension and life expectancy at 5 years after diagnosis is \>80%.

A negative impact of pelvic floor disorders on psychosocial well-being and quality of life are seen in survivors of gynecological cancer, and in cancer survivors this is found to be directly linked with patients regaining continence. Pelvic floor muscle training has few or no side effects, and is acknowledged as first line treatment for all types of urinary incontinence in women. Even though less studied, there is evidence to support pelvic floor muscle training as a safe intervention to reduce symptoms of anal incontinence and improve sexual function. A recent comparative cross-sectional study found that survivors of gynecological cancer with dyspareunia had higher stiffness and lower flexibility, coordination and endurance of the pelvic floor muscles compared to women with a history of total hysterectomy but no pelvic pain. These findings suggest a possible role for pelvic floor muscle training in the prevention and treatment of pelvic floor disorders after gynecological cancer. However, the overall quality of evidence for strengthening the pelvic floor muscles to reduce symptoms of pelvic floor dysfunctions after treatment of gynecological cancer is low.

This study aims to assess the feasibility of a digital pelvic floor rehabilitation programme led by an experienced pelvic floor physiotherapist. Study subjects are women treated for cervical cancer within the past 5 years, and all included participants will receive the intervention due to the feasibility design. Participants will be assessed clinically at baseline and endpoint, partly to ensure proper pelvic floor muscle contraction. The digital intervention ensures residents in rural areas equal access to specialized pelvic floor rehabilitation.

Conditions

• Pelvic Floor Disorder
• Female Pelvic Floor Dysfunction
• Female Sexual Dysfunction
• Female Urinary Incontinence
• Fecal Incontinence
• Secondary Lymphedema
• Pelvic Pain

Interventions

OTHER

Pelvic floor muscle training rehabilitation

The intervention consists of both exercise training, including pelvic floor muscle training, and information about the use of a dilator. At the baseline assessment participants are individually instructed in correct voluntary pelvic floor muscle contractions and how to perform intensive pelvic floor muscle training. The pelvic floor rehabilitation is supported with written information. The exercise program is provided with supervised digital group exercise sessions twice weekly and a home exercise program 4-5 weekly for 16 weeks. The home exercise program will be individualized if needed. The pelvic floor muscle training is following the recommendations for effective training dosage i.e. 3 sets of 10-12 repetitions, 5-7 times per week.

Sponsors & Collaborators

• Sykehuset Ostfold

  collaborator OTHER

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Signe Nilssen Stafne · St. Olavs University Hospital

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-04

Primary Completion

2026-02-28

Completion

2026-07-31

Countries

• Norway

Study Locations