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Degree of Uterine Prolapse and Its Effect on Quality of LifeNCT07080203

Quality of Life Assessment in Patients With Different Degrees of Pelvic Organ Prolapse

An observational study of Degree of Uterine Prolapse and Its Effect on Quality of Life, run by Sohag University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study design: The study building by two design a descriptive exploratory research design and quasi experimental research design were utilized in the present study Setting of the study: This study was conducted at the Outpatient Clinics of Sohag university hospital after approval from the Sohag university medical… Read more about this study

Who is it for?
Ages 18 months and older, women onlyHealthy volunteers can take part
How many people
400 participants
Where
1 siteEgypt
Study dates
1 Dec 2023to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The researcher met with all the women in the childbearing period convenient in outpatient clinics twice weekly and after the researcher introduced herself, explained the goal of the study to them , and obtained formal consent from each women who agreed to participate in the study. Confidentiality of any information obtained was guaranteed, and subjects were informed of their right to participate or not to participate in the study. Anonymity is also assured, and this data will only be used for the study. Data was collected and filled by the researcher via interviewing questionnaire at the beginning the women were asked about their sociodemographic data and medical and obstetric history then they were asked on items included in P-QOL questionnaire which was adopted from (Digesu et al., 2005).and the women with uterine prolapse symptoms and have impairment of quality of life were told that they need to clinical examination to assess the degree of uterine prolapse.

Who may be able to join

  • women in the childbearing period convenient in outpatient clinics twice weekly and sometimes three times per week

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Sohag University

    Sohag, 82749

Other trials in Egypt

About this study

Official title: Effects of Uterine Prolapse Symptoms Based on Degrees and Their Relation to Quality of Life in the Childbearing Period

Study design:

The study building by two design a descriptive exploratory research design and quasi experimental research design were utilized in the present study

Read more

Setting of the study:

This study was conducted at the Outpatient Clinics of Sohag university hospital after approval from the Sohag university medical ethics committee and nursing ethics committee.

Subjects of the study

Sampling:

the sample consists of 400 women.

Sample technique:

a convenient sample of all available women attending outpatient clinics at sohag university hospital and according to the pilot study and demand of the women to clinical investigations also authenticity for the P-QOL. Questionnaire the Quasi experimental research design with purposive sample from the convenient sample were used to confirm the diagnosis and make intervention to improve the quality of life for that women .

Tools of study:

Two tools were utilized and filled by researchers for collecting the data of this study.

The First Tool:

Structured interviewing questionnaire developed by the researcher based on relevant literature divided into three parts.

Part I: socio demographic data as; (age, level of education , income , marital status , place of residence, occupation,).

Part II: Medical history: Related to chronic constipation ,chronic cough and other chronic diseases.

Part III: obstetrical history: Includes (number of pregnancies, number of vaginal deliveries, inter pregnancy interval)

The second Tool: P-QOL. questionnaire adopted from (Digesu et al., 2005) and consist of 9 items (General health perceptions, Prolapse impact, Role limitations, Physical limitations, Social limitations, Personal relationships, Emotions, sleep /energy , Severity measures) then after detect and to determine the degree of prolapse were referred to gynecological clinic to be investigated by clinical supervisor.

Scoring system:

The researcher collected data from patients to complete the P-QOL questionnaire to assess how much their symptoms (if present) were affecting them. Responses ranged from ''not at all, through ''slightly'', ''moderately'' to ''a lot'', from very good to very poor and never to all the time. Therefore, a four- or five-point scoring system according each item was used for severity measurement of uterine prolapse symptoms. Scores in each domain range between 0 and 100. A high total score indicates a greater impairment of quality of life, while a low total score indicates a good quality of life.

  • A score from 0 to 50 indicates women has good quality of life with no symptoms of uterine prolapse
  • A score more than 50 indicates women has impairment of quality of life and need to clinical evaluation to confirm the degree with symptoms of uterine prolapse.

Tool Validity and Reliability:

Validity:

The validity was assessed by measuring levels of missing data, comparing symptom scores between affected and asymptomatic women and lastly comparing symptom scores with objective vaginal examination related to stages of uterine prolapse, in the symptomatic group, as described in the POP-Q, using Spearman's correlation coefficient (construct validity). (Digesu et al., 2005).

Reliability:

The reliability of the questionnaire was assessed by its internal consistency using the Cronbach alpha and stability using a 2-week test-retest analysis. Internal consistency refers to the degree of correlation between the items. Therefore, it is expected that items forming a domain should moderately correlate with each other, but should contribute independently to the overall domain score. A perfect correlation of 1.0 indicates that the questions are measuring an identical construct. A poor correlation instead suggests that the items are testing different traits. A Cronbach alpha of >0.7 has been recommended as acceptable. (Digesu et al., 2005).

Pilot study:

It was carried out on 40 women to understand the feasibility of participant recruitment regarding study design and to ensure that the respondents for the pilot should be as similar as possible for the actual items in terms of age, gender, education, socioeconomic (income) status. It also helped in the estimation of the time needed to fill the tool .Women who participated in pilot study were included in the main study because because no modifications needed to be performed and five cases of them have uterine prolapse symptoms need clinical examination.

Read the detailed description
  • Preparatory phase It included reviewing past, current, local and international related literature and theoretical knowledge of various aspects of the study using books, articles, internet, periodicals and magazines regarding of the effects of uterine prolapse symptoms based on degrees and their relation to quality of life in the childbearing period . the researcher attended the previously mentioned setting twice or sometimes three times per week from 8 Am to 12 p.m .
  • First step The researcher obtained approval from the dean of the Faculty of Nursing at Sohag University, Dean of the Faculty of Medicine at sohag university and director of sohag university hospital
  • Second step The researcher met with all the women in the childbearing period convenient in outpatient clinics twice weekly and sometimes three times per week after the researcher introduced herself, explained the goal of the study to them , and obtained formal consent from each women who agreed to participate in the study. Confidentiality of any information obtained was guaranteed, and subjects were informed of their right to participate or not to participate in the study. Anonymity is also assured, and this data will only be used for the study.

Data was collected and filled by the researcher via interviewing questionnaire at the beginning the women were asked about their sociodemographic data and medical and obstetric history then they were asked on items included in P-QOL questionnaire which was adopted from (Digesu et al., 2005) and consists of 9 items (General health perceptions which include questions such (How would you describe your health at present and How much do you think your prolapse problem affect your life) , Prolapse impact which include urinary and vaginal symptoms such (Going to the toilet to pass urine very often, Urgency:A strong desire to pass urine, Urge incontinence ; urinary leakage associated with a strong desire to pass urine, Stress incontinence ; urinary leakage associated with coughing, Feeling a bulge / lump from or in the vagina , Heaviness or dragging feeling as the day goes on from the vagina or the lower abdomen, Vaginal bulge interfering with you emptying your bowels, Discomfort in the vagina which is worse when standing and relieved by lying down, Poor urinary stream, straining to empty your bladder and Urine dribbles after emptying your bladder) ,bowel and vaginal symptoms which include (Bowels do not feel completely empty after opening, Constipation ;difficulty in emptying, Straining to open your bowels, vaginal bulge which gets in the way of sex, Lower backache worsens with vaginal discomfort, Do you help empty your bowels with your fingers? How often do you open your bowels? , Role limitation which include questions such as ( To what extent does your prolapse affect your household tasks ( e.g. cleaning ,shopping )? And Does you prolapse affect your job or your normal daily activities outside the home ?) , Physical and social limitations which include questions such as (Does your prolapse affect your physical activities (e.g. going for a walk , run , sport , gym etc.)?, Does your prolapse affect your ability to travel, Does your prolapse limit your social life? And Does your prolapse limit your ability to see/visit friends ?) , Personal relationships which include such as(Does your prolapse affect your relationship with your partner ?, Does your prolapse affect your sex life? and Does your prolapse affect your family life?.) , Emotions which include questions such as ( Does your prolapse make you feel depressed, Does your prolapse make you feel anxious or nervous ? and Does your prolapse make you feel bad about you self?) , sleep /energy questions which include (Does your prolapse affect your sleep ?and Do you feel worn out / tired ?) ,Severity measures which include(Use tampons /pads /firm knickers to help?, Do you push up the prolapse?, Pain or discomfort due to the prolapse ? and Does the prolapse prevent you from standing ?).

After the women answered these questions. According to the reported symptoms by the women the researcher knew if the women have symptoms of uterine prolapse or no and have good quality of life or impairment in quality of life according to scoring system in P-QOL questionnaire . Once the questionnaires had been completed and collected, an explanation of what had been measured was given to the women and assurances were given also and the women with uterine prolapse symptoms and have impairment of quality of life were told that they need to clinical examination to confirm if they have uterine prolapse or no and if they have uterine prolapse which degree they have. Moreover the researcher explained by booklet for the women about uterine prolapse definition ,causes, risk factors, degrees, symptoms and how to prevent themselves from having uterine prolapse Then the researcher told the women having uterine prolapse symptoms to be in contact with her to find near available time with the physician for clinical examination .

-Third step The researcher was in contact with the physician to determine an available time to examine cases which have symptoms of uterine prolapse . and then the researcher told the women through their mobile phone about time for examination determined by physician .that was about three times monthly every time about four or five cases according to accessibility came for clinical examination .Examination for cases occurred in two places in Feto-maternal unit in special clinics and department of obstetric and gynecology (OBGYN) in sonography room . when the women arrived to hospital waiting room during this the researcher repeated what had been explained for the women about uterine prolapse definition ,causes, risk factors, degrees, symptoms and how to prevent themselves from having uterine prolapse after that the women came to the examination room which was prepared before women coming with sterile Cusco-speculum according to number of cases and sterilization of examination bed then women are asked to empty her bladder before entering the room then women entered the room and nurse in examination room asked the women to keep her clothes down and put women in supine position with knee slightly flexed and rotated outward with complete keeping privacy during examination . after that physician wear gloves and begin to examine cases per vaginal examination at first uses transvaginal sonography to screen uterus ,ovaries ,fallopian tube ,endometrium for any lesion ,polyp, cyst and myoma then sterile Cusco-speculum with lubricated gel slightly inserted through the vagina to determine uterine decent especially in cases of first degree uterine prolapse where cannot be seen through the vaginal decent because in first degree uterine prolapse cervix is below ischial spine then prevaginal examination is done and physician put his fingers in posterior wall of the vagina and ask women to cough to see if there is any vaginal bulge this help to determine if women have cystocele or no and repeat this in anterior wall of the vagina to detect if women has rectocele or no. then physician removed gloves and ask women to be in comfortable position . with examination physician detected some problems which women have as urinary tract infection such as vaginitis or cervicitis so physician described proper treatment for such cases as well as told and reassure women how to manage uterine prolapse according to degree and the researcher repeated what physician has said to women and help in direction of cases to follow physician instructions Lastly, after finishing lots of thanks were given to women for their cooperation.

There were about 50 women which don't have any uterine prolapse symptoms asked if they allowed to do clinical examination to confirm that if they have uterine prolapse or no so clinical examination was done for them and illustrated that they actually don't have uterine prolapse .

Administrative design:

An official letter approval was obtained from Dean of the Faculty of Medicine and Faculty of Nursing at Sohag University to directors of previous setting in Sohag University. This letter included a brief explanation of the objectives of the study and permission to carry out the study

Keywords
Uterine Prolapse, Quality of Life, Childbearing period
Medical subject headings
Uterine Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07080203
Study groupRoleWhat they receive
group 1all available women attending outpatient clinics at sohag university hospital and according to the pilot study and demand of the women to clinical investigations also authenticity for the P-QOL. Questionnaire the Quasi experimental research design with purposive sample from the convenient sample were used to confirm the diagnosis and make intervention to improve the quality of life for that women.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. effect of uterine prolapse on quality of life

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start1 Dec 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07080203
Sponsor's protocol ID
Soh-Med-23-12-04MS
Status last verified
Jul 2025
First submitted
14 Jul 2025
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: decision is still under discussion by all research team

Publications

  • Tega A, Yenealem F, Belay G, Asmare E, Getaneh T, Desalegn M, Dechasa N, Addis Z. Quality of life and its associated factors among women with pelvic organ prolapse who attend gynecology clinics Southern Ethiopia 2022. BMC Womens Health. 2024 Jul 12;24(1):398. doi: 10.1186/s12905-024-03238-1.

    PubMed 38997642
  • Tefera Z, Temesgen B, Arega M, Getaneh T, Belay A. Quality of life and its associated factors among women diagnosed with pelvic organ prolapse in Gynecology outpatient department Southern Nations, Nationalities, and Peoples region public referral hospitals, Ethiopia. BMC Womens Health. 2023 Jun 28;23(1):342. doi: 10.1186/s12905-023-02507-9.

    PubMed 37380942
  • Tahmina Afrin ., Furatul,H., Shahidul,I., Zahid ,B., Zakia ,R., Abid ,H., Abul Kasem ,M.( 2017-2018) DU Roll: 1292 Reg no: 10223, Quality of Life Among women Having Genital Prolapse, Saic College of Medical Science and Technology Department of physiotherapy )

  • Shehata Ibrahim, S., Mohamed Elbhlwan, G. A., & Mansour, S. A. (2023). Knowledge and Practices of Women Regarding Risk Factors and Preventive Measures of Vaginal Prolapse. Port Said Scientific Journal of Nursing, 10(2), 299-319.

  • Rashad, M., Fadel, E., & El-Nemer, A. (2018). Women's knowledge regarding pelvic organ Shavkatovich, S. X. (2025). Incidence Rates of Genital Prolapse in Women of Reproductive Age. Web of Medicine: Journal of Medicine, Practice and Nursing, 3(1), 145-149.

  • Ramadan Hassan, S. G., Moustafa, M. F., Mohamed, H. A. E., El-Malek, A., & Samier, A. (2020). Effect of Kegel Exercise on Improving Manifestations of Uterine Prolapse among Pre menopausal Women. Minia Scientific Nursing Journal, 8(1), 75-82.

  • Olimjonovna, T. D. (2025). UTERINE PROLAPSE IS A DELICATE PROBLEM FOR WOMEN. Modern education and development, 19(3), 163-171. prolapse. Mansoura Nursing Journal, 5(3), 57-67.

  • Okonofua, F., Balogun, J. A., Odunsi, K., & Chilaka, V. N. (Eds.). (2021). Contemporary obstetrics and gynecology for developing countries. Springer.

  • Mohammed Saeed, N., Mohamed Fahmy, N., Abdelhalem Said, S., & Abozied Ramadan, E. (2022). Effect of Nursing Intervention Package on Prevention of Uterine Prolapse among Pregnant Women in Third Trimester. Journal of Nursing Science Benha University, 3(1), 918-939.

  • Martins, F. E. (2025). Pelvic Organ Prolapse and Sexual Dysfunction. Société Internationale d'Urologie Journal, 6(1), 19.

  • Kurniadi A, Dewi AK, Sasotya RMS, Purwara BH, Kireina J. Effect of Vitamin D analog supplementation on levator ani strength and plasma Vitamin D receptor expression in uterine prolapse patients. Sci Rep. 2023 Mar 3;13(1):3616. doi: 10.1038/s41598-023-30842-2.

    PubMed 36869168
  • Kayondo M, Kaye DK, Migisha R, Tugume R, Kato PK, Lugobe HM, Geissbuehler V. Impact of surgery on quality of life of Ugandan women with symptomatic pelvic organ prolapse: a prospective cohort study. BMC Womens Health. 2021 Jun 25;21(1):258. doi: 10.1186/s12905-021-01397-z.

    PubMed 34172043
  • K Khalil, A., Ahmed Mohmed Elbahlowan, G., E Nady, S., & ES, A. (2024). Guidelines for Nursing Care: Effect on Quality of Sexual Life among Women with Vaginal Prolapse. Egyptian Journal of Health Care, 15(4), 818-832.

  • Jayashree, K., Indira, A., & Viji, A. (2022). Impact Of Nurse Led Bundle Care Therapy On Pop Symptoms Among Women With Prolapsed Uterus. Journal of Pharmaceutical Negative Results, 125-131.

  • Gonzalez-Timoneda A, Valles-Murcia N, Munoz Esteban P, Torres Lopez MS, Turrion Martinez E, Errandonea Garcia P, Serrano Raya L, Nohales Alfonso F. Prevalence and impact of pelvic floor dysfunctions on quality of life in women 5-10 years after their first vaginal or caesarian delivery. Heliyon. 2025 Jan 21;11(3):e42018. doi: 10.1016/j.heliyon.2025.e42018. eCollection 2025 Feb 15.

    PubMed 39916837

Questions about this trial

What is this clinical trial studying?

An observational study of Degree of Uterine Prolapse and Its Effect on Quality of Life, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effect of uterine prolapse on quality of life (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07080203, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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