NCT07538752

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

Continuous Care ModelPsychological Distressquality of lifeUrinary Incontinence

Outcome Measures

Primary Outcomes (2)

  • Psychological distress

    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.

    6 months

  • Women' quality of life.

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

    6 months

Study Arms (2)

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.

Behavioral: Continuous Care Model sessions

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.

Interventions

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

intervention group, which received the continuous care model.

Eligibility Criteria

Age45 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen diagnosed with urinary incontinence during the postmenopausal phase and having the ability to read and write.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Quds University

East Jerusalem, Abu Dies, 51000, Palestinian Territories

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

May 1, 2025

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations