Clinical trial · Observational
Treatments for Urogynaecological Problems and Patient Selfreports
Relationship Between Treatments for Urogynecological Problems and Patient Reported Values, Psychological States, and Quality of Life
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urogynaecological Problem, Pelvic Floor Dysfunction, Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic Floor Muscle Training | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Change in objective physical outcomes
- timeFrame
- 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.
- description
- Oxford Grading
- measure
- Change in self reported depression and anxiety
- timeFrame
- 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.
- description
- 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.
- measure
- Change in self reported quality of life
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * consenting patients who are referred for pelvic floor problems to Singleton Hospital Swansea, UK. Exclusion Criteria: * under 18 years
References
Publications (2)
- DERIVEDOsborne 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
- DERIVEDReed 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