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Recruiting NCT02549157

NCT02549157 Treatments for Urogynaecological Problems and Patient Selfreports

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Clinical Trial Summary
NCT ID NCT02549157
Status Recruiting
Phase
Sponsor Swansea University
Condition Urogynaecological Problem, Pelvic Floor Dysfunction, Cancer
Study Type OBSERVATIONAL
Enrollment 500 participants
Start Date 2015-09-01
Primary Completion 2025-09-30

Trial Parameters

Condition Urogynaecological Problem, Pelvic Floor Dysfunction, Cancer
Sponsor Swansea University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2015-09-01
Completion 2025-09-30
Interventions
Pelvic Floor Muscle Training

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * consenting patients who are referred for pelvic floor problems to Singleton Hospital Swansea, UK. Exclusion Criteria: * under 18 years

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