Skip to main content
OpenTrials
Completed

NCT Number: NCT07538752

The Effect of Continuous Care Model on Psychological Distress and Quality of Life Among Postmenopausal Women With Urinary Incontinence

This research aimed to evaluate the effect of continuous care model on psychological distress and quality of life among postmenopausal women with urinary incontinence.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Background: Urinary incontinence is a common problem experienced by postmenopausal women, which greatly impacts their psychological state and quality of life. Although urinary incontinence is a common problem, it is often underreported.

Aim: This research aimed to evaluate the effect of continuous care model on psychological distress and quality of life among postmenopausal women with urinary incontinence.

Design: A Randomized Controlled Trial with pre-test and post-test assessments in both intervention and control groups was conducted.

Setting: The present research was conducted in Egypt, Gharbia Governorate, Tanta city, at gynecological outpatient clinics of Tanta University Hospital and El-Menshawy Hospital.

Tools: A structured interviewing questionnaire, Kessler Psychological Distress Scale, Incontinence Impact Questionnaire (IIQ-7), and incontinence severity index.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women diagnosed with urinary incontinence during the postmenopausal phase
  • Women having the ability to read and write.

Exclusion criteria

  • Women with diabetic nephropathy.
  • Women with previous central nervous system injuries.
  • Women with bladder cancer.
  • Women with urinary tract infections,
  • Women with other significant neurological disorders.

Treatment and study plan

Continuous Care Model sessions

Behavioral

Continuous care model promotes ongoing, valuable, and consistent dialogue between nurses and women with urinary incontinence in order to identify their needs and preferences and supports them in embracing healthier habits by providing tailored information and structured guidance. This approach aids women in gaining accurate knowledge about their conditions and empowers them to take charge of their health by proactively addressing their own health issues. The model encourages women to participate in developing their care plan, taking ownership of monitoring their health continuously, and averting potential complications.

The main objective of providing nursing care for urinary incontinence is to maintain the woman's continence and support her in carrying out daily activities despite the limitations caused by the condition. Recognizing that women often keep urinary incontinence issues private and avoid seeking healthcare, screening programs are vital in identifying urinary incontinence

Primary outcomes

  1. Psychological distress

    Time frame: 6 months

    Psychological distress was measured using the Kessler Psychological Distress Scale (K10), a frequently used self-report tool for assessing symptoms of anxiety and depression. The K10 scale consists of 10 items, with each item rated on a 5-point Likert scale ranging from "none of the time" (1) to "all of the time" (5), yielding a total score between 10 and 50, indicating that higher scores signify greater psychological distress. The results are commonly interpreted using categorized thresholds: scores between 10 and 19 indicate a low likelihood of psychological distress, 20-24 suggest mild distress, 25-29 indicate moderate distress, and scores between 30 and 50 reflect severe psychological distress.

  2. Women' quality of life.

    Time frame: 6 months

    The IIQ-7 was adopted from Uebersax et al., (1995) and specifically designed to evaluate the influence of UI on women' quality of life.

Sponsors and collaborators

Lead sponsor

Al-Quds University

Other

Registry information

Official study title

The Effect of Continuous Care Model on Psychological Distress and Quality of Life Among Postmenopausal Women With Urinary Incontinence: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.