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Clinical Trials/NCT07538752
NCT07538752
Completed
Not Applicable

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

Al-Quds University1 site in 1 country98 target enrollmentStarted: May 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
98
Locations
1
Primary Endpoint
Psychological distress

Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
45 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

intervention group, which received the continuous care model.

Experimental

The study examined the effects of the intervention ( continuous care model) on the psychological distress and quality of life of postmenopausal women who experienced urinary incontinence.

Intervention: Continuous Care Model sessions (Behavioral)

Control group (no intervention)

No Intervention

The control group was provided with standard care at the outpatient clinics but did not receive the Continuous Care Model sessions. They were assessed at the same time as the intervention group.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ashraf Jehad Abuejheisheh

Dr.

Al-Quds University

Study Sites (1)

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