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ENROLLING BY INVITATION
NCT06786091
NA

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

Sponsor: St. Olavs Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-02-04

Completion Date

2026-07

Last Updated

2025-06-05

Healthy Volunteers

No

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.

Locations (2)

St.Olavs University Hopsital

Trondheim, Trøndelag, Norway

Østfold Hospital

Fredrikstad, Østfold fylke, Norway