Treatments for Urogynaecological Problems and Patient Selfreports

NCT02549157 | Recruiting

• 1 other identifier: IRAS project ID: 130775
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Urogynaecological Problem, Pelvic Floor Dysfunction, Cancer

Outcome Measures

Primary Outcomes (4)

• Change in objective physical outcomes

  Oxford Grading

  Initial measures will be taken about 4 weks pre-treatment, and then again 4 weeks post-treatment. Follow-up measures will be taken after abou 3 months, and then after 1 year for each of the next 4 years.

• Change in self reported depression and anxiety

  Hospital Anxiety and Depresion Scales, ranging from 0-21 for both scales, with 9 or more being considered as showing signs of depression or anxiety.

  Initial measures will be taken about 4 weks pre-treatment, and then again 4 weeks post-treatment. Follow-up measures will be taken after abou 3 months, and then after 1 year for each of the next 4 years.

• Change in self reported quality of life

  Euro-qual 5D measures health related quality of life on 5 dimensons (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each rated as: "no problems," "slight problems," "moderate problems," "severe problems," and "unable to"/"extreme problems"

  Initial measures will be taken about 4 weks pre-treatment, and then again 4 weeks post-treatment. Follow-up measures will be taken after abou 3 months, and then after 1 year for each of the next 4 years.

• Change in personal values

  Personal Values Questionnaire measures patient selected areas of their life which they value (e.g., health, family), giving a score between 0 and 25, with higher scores indicating a more strongly heald value.

  Initial measures will be taken about 4 weks pre-treatment, and then again 4 weeks post-treatment. Follow-up measures will be taken after abou 3 months, and then after 1 year for each of the next 4 years.

Interventions

Pelvic Floor Muscle Training PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients referred for treatments (physiotherapy, surgery) for urogynaecological problems (pelvic floor dysfunction, cancer) will be asked if they would like to participate in this study. Initial approach will be made through letter sent out with their appointment details, which will give information about the study. This will make clear that their treatment will not depend on their participation in the study. The patients also will be given the chance to discuss their participation with the specialist nurse at the time of their pre-treatment assessment, and will give their consent (by completing and signing a Consent Form) on the day of their taking part in the research study, after they have had time to think about their participation and ask any questions that they may have.

You may qualify if:

• consenting patients who are referred for pelvic floor problems to Singleton Hospital Swansea, UK.

You may not qualify if:

• under 18 years

Sponsors & Collaborators

• Swansea University: lead
• Abertawe Bro Morgannwg University Health Board: collaborator

Study Sites (1)

Singleton Hospital

Swansea, SA2 8PP, United Kingdom

RECRUITING

Related Publications (2)

• Osborne LA, Mair Whittall C, Emery S, Reed P. Change in depression predicts change in bladder symptoms for women with urinary incontinence undergoing pelvic-floor muscle training. Eur J Obstet Gynecol Reprod Biol. 2023 Jan;280:54-59. doi: 10.1016/j.ejogrb.2022.11.010. Epub 2022 Nov 14.

  PMID: 36402023 DERIVED

• Reed P, Osborne LA, Whittall CM, Emery S. Impact of patient motivation on compliance and outcomes for incontinence. Physiotherapy. 2021 Dec;113:100-106. doi: 10.1016/j.physio.2020.10.003. Epub 2020 Oct 24.

  PMID: 34563914 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Phil Reed, D.Phil.

  Swansea University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa A Osborne, D.Phil.

CONTACT

0044 (0)1792 285229; lisa.osborne@nhs.wales.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Phil Reed

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

GB (1)