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Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners

NCT02103088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-02-04

No results posted yet for this study

Summary

Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of the prostate gland (prostatectomy) which may be associated with immediate and long lasting erectile dysfunction and decline in urinary function. Besides these physical late effects patients operated for PC have a twofold increased risk for depression up to ten years after the diagnosis. To reduce these late effects affecting both patient and partner the investigators have developed a sexual and urological intervention (PROCAN). The intervention is based on epidemiological data, evidence from previous clinical trials, a feasibility study and qualitative explorations among PC patients and partners. The investigators hereby suggest the conduction of a randomized controlled trial to test the effect of the PROCAN intervention on urological and sexual dysfunction, couples adjustment and quality of life. Results of the proposed trial may provide clinicians and decision makers with the evidence needed to optimize rehabilitation after PC.

Conditions

Interventions

BEHAVIORAL

Sexual and urological intervention

Sexual and urological intervention consisting of: i) DVD instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor.

Sponsors & Collaborators

  • The Capital Region Research Foundation for Health Research Denmark

    collaborator UNKNOWN

  • Department of Urology Rigshospitalet Copenhagen Denmark

    collaborator UNKNOWN

  • Clinic for Sexology and Center for Psychiatry Copenhagen Denmark

    collaborator UNKNOWN

  • Department of Ergotherapy and Physiotherapy Rigshospitalet Copenhagen Denmark

    collaborator UNKNOWN

  • Danish Cancer Society

    lead OTHER

Principal Investigators

  • Christoffer Johansen, PhD, Dr. Med · Danish Cancer Society

  • Randi V. Karlsen, RN, MEd · Danish Cancer Society

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-01-31
Completion
2021-02-28

Countries

  • Denmark

Study Locations

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Entities

Diseases

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 NCT02103088 on ClinicalTrials.gov