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Treatments for Urogynaecological Problems and Patient Selfreports

NCT02549157 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-11-29

No results posted yet for this study

Summary

The research aims to assess the relationship between treatments for a range of urogynaecological problems (pelvic floor dysfunction, cancers) and patient reported values, psychological states, and quality of life. The impact of treatments on patients' health outcomes will be measured, using specific urogynaecological outcome measures (for either pelvic floor dysfunction or cancer), and patient reported measures of general health and quality of life. Patients' psychological states and values will be measured by validated self-report instruments for these areas. Researchers will obtain consent for participation from patients. Following consent, baseline measures will be taken at the patients' routine appointment about 4 weeks prior to undergoing treatment (e.g., surgery or physiotherapy for pelvic floor dysfunction, or surgery for a urogynaecology cancer). These measures will be the routinely collected physical data obtained by medical staff, and patient reported measures of their general health, psychological state, and quality of life. These questionnaires should take about 30 minutes to complete, in total. The patients will undergo treatment (physiotherapy programme or surgery), which will not be affected by this research. About four weeks post treatment, patients will receive their usual appointment, and routinely collected physical data will be obtained by medical staff, and patients will complete the measures as described above. With the patient's consent, the above evaluation will be repeated at every follow-up appointment that the patient has (i.e. after 3months, and then at yearly intervals, for 5 years). The impact of treatments on objective routine health measures taken by medical staff, and on patient reported measures of health, quality of life, personal values, and psychological functioning, will be documented at each measurement point. Additionally, relationships between psychological states/values and both objective and subjective ratings of how treatments have impacted the patients will be established.

Conditions

  • Urogynaecological Problem, Pelvic Floor Dysfunction, Cancer

Interventions

PROCEDURE

Pelvic Floor Muscle Training

Sponsors & Collaborators

  • Abertawe Bro Morgannwg University Health Board

    collaborator OTHER

  • Swansea University

    lead OTHER

Principal Investigators

  • Phil Reed, D.Phil. · Swansea University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United Kingdom

Study Locations

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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 NCT02549157 on ClinicalTrials.gov